Synthroid (Page 6 of 6)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Standard animal studies have not been performed to evaluate the carcinogenic potential, mutagenic potential or effects on fertility of levothyroxine.

16 HOW SUPPLIED/STORAGE AND HANDLING

SYNTHROID (levothyroxine sodium, USP) tablets are supplied as follows:

Strength (mcg) Color/Shape TabletMarkings NDC# for bottles of 90 NDC # for bottles of 1000 NDC # forunit dose cartons of 100
25 Orange/Round “SYNTHROID”and “25” 0074-4341-90 0074-4341-19
50 White/Round “SYNTHROID”and “50” 0074-4552-90 0074-4552-19 0074-4552-11
75 Violet/Round “SYNTHROID”and “75” 0074-5182-90 0074-5182-19 0074-5182-11
88 Olive/Round “SYNTHROID”and “88” 0074-6594-90 0074-6594-19
100 Yellow/Round “SYNTHROID”and “100” 0074-6624-90 0074-6624-19 0074-6624-11
112 Rose/Round “SYNTHROID”and “112” 0074-9296-90 0074-9296-19
125 Brown/Round “SYNTHROID”and “125” 0074-7068-90 0074-7068-19 0074-7068-11
137 Turquoise/Round “SYNTHROID”and “137” 0074-3727-90 0074-3727-19
150 Blue/Round “SYNTHROID”and “150” 0074-7069-90 0074-7069-19 0074-7069-11
175 Lilac/Round “SYNTHROID”and “175” 0074-7070-90 0074-7070-19
200 Pink/Round “SYNTHROID”and “200” 0074-7148-90 0074-7148-19 0074-7148-11
300 Green/Round “SYNTHROID”and “300” 0074-7149-90 0074-7149-19

Storage Conditions

Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F)

[see USP Controlled Room Temperature]. SYNTHROID tablets should be protected from light and moisture.

17 PATIENT COUNSELING INFORMATION

Inform the patient of the following information to aid in the safe and effective use of SYNTHROID:

Dosing and Administration

  • Instruct patients to take SYNTHROID only as directed by their healthcare provider.
  • Instruct patients to take SYNTHROID as a single dose, preferably on an empty stomach, one-half to one hour before breakfast.
  • Inform patients that agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine. Instruct patients not to take SYNTHROID tablets within 4 hours of these agents.
  • Instruct patients to notify their healthcare provider if they are pregnant or breastfeeding or are thinking of becoming pregnant while taking SYNTHROID.

Important Information

  • Inform patients that it may take several weeks before they notice an improvement in symptoms.
  • Inform patients that the levothyroxine in SYNTHROID is intended to replace a hormone that is normally produced by the thyroid gland. Generally, replacement therapy is to be taken for life.
  • Inform patients that SYNTHROID should not be used as a primary or adjunctive therapy in a weight control program.
  • Instruct patients to notify their healthcare provider if they are taking any other medications, including prescription and over-the-counter preparations.
  • Instruct patients to notify their physician of any other medical conditions they may have, particularly heart disease, diabetes, clotting disorders, and adrenal or pituitary gland problems, as the dose of medications used to control these other conditions may need to be adjusted while they are taking SYNTHROID. If they have diabetes, instruct patients to monitor their blood and/or urinary glucose levels as directed by their physician and immediately report any changes to their physician. If patients are taking anticoagulants, their clotting status should be checked frequently.
  • Instruct patients to notify their physician or dentist that they are taking SYNTHROID prior to any surgery.

Adverse Reactions

  • Instruct patients to notify their healthcare provider if they experience any of the following symptoms: rapid or irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleeplessness, tremors, change in appetite, weight gain or loss, vomiting, diarrhea, excessive sweating, heat intolerance, fever, changes in menstrual periods, hives or skin rash, or any other unusual medical event.
  • Inform patients that partial hair loss may occur rarely during the first few months of SYNTHROID therapy, but this is usually temporary.

© 2020 AbbVie Inc.

AbbVie Inc.

North Chicago, IL 60064, U.S.A.

20063914 July 2020

NDC 0074-4552-11

Synthroid®

Levothyroxine Sodium Tablets, USP

50 mcg (0.05 mg)

100 Tablets

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Rx only abbvie

carton-synthroid-50mcg-100ct-hud
(click image for full-size original)

NDC 0074-6624-11

Synthroid®

Levothyroxine Sodium Tablets, USP

100 mcg (0.1 mg)

100 Tablets

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Rx only abbvie

carton-synthroid-100mcg-100ct-hud
(click image for full-size original)

NDC 0074-7148-11

Synthroid®

Levothyroxine Sodium Tablets, USP

200 mcg (0.2 mg)

100 Tablets

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Rx only abbvie

carton-synthroid-200mcg-100ct-hud
(click image for full-size original)

NDC 0074-3727-90

Synthroid®

Levothyroxine Sodium Tablets, USP

137 mcg (0.137 mg)

90 Tablets

Rx only abbvie

synthroid-137mcg-90ct
(click image for full-size original)

NDC 0074-4341-19

Synthroid®

Levothyroxine Sodium Tablets, USP

25 mcg (0.025 mg)

1000 Tablets

Rx only abbvie

synthroid 25 mcg 1000ct
(click image for full-size original)

NDC 0074-5182-19

Synthroid®

Levothyroxine Sodium Tablets, USP

75 mcg (0.075 mg)

1000 Tablets

Rx only abbvie

synthroid 75 mcg 1000ct
(click image for full-size original)

NDC 0074-6594-90

Synthroid®

Levothyroxine Sodium Tablets, USP

88 mcg (0.088 mg)

90 Tablets

Rx only abbvie

synthroid 88 mcg 90 ct
(click image for full-size original)

NDC 0074-7068-19

Synthroid®

Levothyroxine Sodium Tablets, USP

125 mcg (0.125 mg)

1000 Tablets

Rx only abbvie

synthroid 125 mcg 1000ct
(click image for full-size original)

NDC 0074-7069-90

Synthroid®

Levothyroxine Sodium Tablets, USP

150 mcg (0.15 mg)

90 Tablets

Rx only abbvie

synthroid 150 mcg 90 ct
(click image for full-size original)

NDC 0074-7070-19

Synthroid®

Levothyroxine Sodium Tablets, USP

175 mcg (0.175 mg)

1000 Tablets

Rx only abbvie

synthroid 175 mcg 1000 ct
(click image for full-size original)

NDC 0074-7149-90

Synthroid®

Levothyroxine Sodium Tablets, USP

300 mcg (0.3 mg)

90 Tablets

Rx only abbvie

synthroid 300 mcg 90 ct
(click image for full-size original)

NDC 0074-9296-19

Synthroid®

Levothyroxine Sodium Tablets, USP

112 mcg (0.112 mg)

1000 Tablets

Rx only abbvie

synthroid 112 mcg 1000ct
(click image for full-size original)

NDC 0074-4341-72

2 cards x 7 tablets

orange 25mcg (0.025mg) Synthroid

Synthroid ®

levothyroxine sodium tablets, USP

www.synthroid.com

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Professional sample. Not for sale. Rx only abbvie

carton-synthroid-25mcg-14ct-sample
(click image for full-size original)

NDC 0074-4552-90

Synthroid®

Levothyroxine Sodium Tablets, USP

50 mcg

(0.05mg)

90 Tablets

Rx only abbvie

synthroid-50mcg-90ct-tablets
(click image for full-size original)

NDC 0074-5182-72 2 cards x 7 tablets

violet 75 mcg (0.075 mg) Synthroid

Synthroid®

levothyroxine sodium tablets, USP

www.synthroid.com

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Professional sample. Not for sale. Rx only abbvie

carton-synthroid-75mcg-14ct-tablet-sample
(click image for full-size original)

NDC 0074-9296-72 2 cards x 7 tablets

rose 112mcg (0.112 mg) Synthroid

Synthroid®

levothyroxine sodium tablets, USP

www.synthroid.com

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Professional sample. Not for sale. Rx only abbvie

carton-synthroid-112mcg-14ct-tablets-sample
(click image for full-size original)

NDC 0074-7148-90

Synthroid®

Levothyroxine Sodium Tablets, USP

200 mcg

(0.2 mg)

90 Tablets

Rx only abbvie

label-synthroid-200mcg-90ct-tablets
(click image for full-size original)

NDC 0074-6624-72 2 cards x 7 tablets

yellow 100 mcg (0.1mg) Synthroid

Synthroid®

levothyroxine sodium tablets, USP

www.synthroid.com

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Professional sample. Not for sale. Rx only abbvie

carton-synthroid-100mcg-14ct-tablet-sample
(click image for full-size original)

NDC 0074-6624-90

Synthroid®

Levothyroxine Sodium Tablets, USP

100 mcg

(0.1 mg)

90 Tablets

Rx only abbvie

label-synthroid-100mcg-90ct-tablets
(click image for full-size original)
SYNTHROID levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-7149
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 300 ug
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
FD&C BLUE NO. 1
SUCROSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color GREEN Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code SYNTHROID;300
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-7149-90 90 TABLET in 1 BOTTLE None
2 NDC:0074-7149-19 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021402 07/24/2002
SYNTHROID levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-4341
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 25 ug
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
FD&C YELLOW NO. 6
SUCROSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color ORANGE Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code SYNTHROID;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-4341-13 100 TABLET in 1 BOTTLE None
2 NDC:0074-4341-90 90 TABLET in 1 BOTTLE None
3 NDC:0074-4341-19 1000 TABLET in 1 BOTTLE None
4 NDC:0074-4341-72 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-4341-72)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021402 07/24/2002
SYNTHROID levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-4552
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 50 ug
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
SUCROSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code SYNTHROID;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-4552-13 100 TABLET in 1 BOTTLE None
2 NDC:0074-4552-90 90 TABLET in 1 BOTTLE None
3 NDC:0074-4552-19 1000 TABLET in 1 BOTTLE None
4 NDC:0074-4552-11 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (0074-4552-11)
5 NDC:0074-4552-71 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-4552-71)
6 NDC:0074-4552-72 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-4552-72)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021402 07/24/2002
SYNTHROID levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-5182
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 75 ug
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
FD&C RED NO. 40
FD&C BLUE NO. 2
SUCROSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color PURPLE (Violet) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code SYNTHROID;75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-5182-13 100 TABLET in 1 BOTTLE None
2 NDC:0074-5182-90 90 TABLET in 1 BOTTLE None
3 NDC:0074-5182-71 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-5182-71)
4 NDC:0074-5182-19 1000 TABLET in 1 BOTTLE None
5 NDC:0074-5182-11 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
5 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (0074-5182-11)
6 NDC:0074-5182-72 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-5182-72)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021402 07/24/2002
SYNTHROID levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-6624
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 100 ug
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
SUCROSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code SYNTHROID;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-6624-13 100 TABLET in 1 BOTTLE None
2 NDC:0074-6624-90 90 TABLET in 1 BOTTLE None
3 NDC:0074-6624-19 1000 TABLET in 1 BOTTLE None
4 NDC:0074-6624-11 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (0074-6624-11)
5 NDC:0074-6624-71 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-6624-71)
6 NDC:0074-6624-72 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-6624-72)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021402 07/24/2002
SYNTHROID levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-6594
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 88 ug
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
SUCROSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color GREEN (Olive) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code SYNTHROID;88
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-6594-13 100 TABLET in 1 BOTTLE None
2 NDC:0074-6594-90 90 TABLET in 1 BOTTLE None
3 NDC:0074-6594-71 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-6594-71)
4 NDC:0074-6594-19 1000 TABLET in 1 BOTTLE None
5 NDC:0074-6594-72 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-6594-72)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021402 07/24/2002
SYNTHROID levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-9296
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 112 ug
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
D&C RED NO. 27
D&C RED NO. 30
SUCROSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color RED (Rose) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code SYNTHROID;112
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-9296-13 100 TABLET in 1 BOTTLE None
2 NDC:0074-9296-90 90 TABLET in 1 BOTTLE None
3 NDC:0074-9296-19 1000 TABLET in 1 BOTTLE None
4 NDC:0074-9296-71 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-9296-71)
5 NDC:0074-9296-72 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-9296-72)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021402 07/24/2002
SYNTHROID levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-7068
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 125 ug
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
FD&C YELLOW NO. 6
FD&C RED NO. 40
FD&C BLUE NO. 1
SUCROSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color BROWN Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code SYNTHROID;125
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-7068-13 100 TABLET in 1 BOTTLE None
2 NDC:0074-7068-90 90 TABLET in 1 BOTTLE None
3 NDC:0074-7068-71 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-7068-71)
4 NDC:0074-7068-19 1000 TABLET in 1 BOTTLE None
5 NDC:0074-7068-11 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
5 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (0074-7068-11)
6 NDC:0074-7068-72 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-7068-72)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021402 07/24/2002
SYNTHROID levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-3727
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 137 ug
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
FD&C BLUE NO. 1
SUCROSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color BLUE (Turquoise) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code SYNTHROID;137
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-3727-13 100 TABLET in 1 BOTTLE None
2 NDC:0074-3727-90 90 TABLET in 1 BOTTLE None
3 NDC:0074-3727-71 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-3727-71)
4 NDC:0074-3727-19 1000 TABLET in 1 BOTTLE None
5 NDC:0074-3727-72 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-3727-72)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021402 07/24/2002
SYNTHROID levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-7069
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 150 ug
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
FD&C BLUE NO. 2
SUCROSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code SYNTHROID;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-7069-90 90 TABLET in 1 BOTTLE None
2 NDC:0074-7069-71 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-7069-71)
3 NDC:0074-7069-19 1000 TABLET in 1 BOTTLE None
4 NDC:0074-7069-11 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (0074-7069-11)
5 NDC:0074-7069-72 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-7069-72)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021402 07/24/2002
SYNTHROID levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-7070
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 175 ug
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
FD&C BLUE NO. 1
D&C RED NO. 27
D&C RED NO. 30
SUCROSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color PURPLE (Lilac) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code SYNTHROID;175
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-7070-13 100 TABLET in 1 BOTTLE None
2 NDC:0074-7070-90 90 TABLET in 1 BOTTLE None
3 NDC:0074-7070-71 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-7070-71)
4 NDC:0074-7070-19 1000 TABLET in 1 BOTTLE None
5 NDC:0074-7070-72 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-7070-72)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021402 07/24/2002
SYNTHROID levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-7148
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 200 ug
Inactive Ingredients
Ingredient Name Strength
ACACIA
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC
FD&C RED NO. 40
SUCROSE
POVIDONE, UNSPECIFIED
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code SYNTHROID;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0074-7148-90 90 TABLET in 1 BOTTLE None
2 NDC:0074-7148-19 1000 TABLET in 1 BOTTLE None
3 NDC:0074-7148-71 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-7148-71)
4 NDC:0074-7148-11 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (0074-7148-11)
5 NDC:0074-7148-72 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 7 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0074-7148-72)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021402 02/24/2002
Labeler — AbbVie Inc. (078458370)

Revised: 07/2020 AbbVie Inc.

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