LEVOXYL (Page 6 of 6)

Pregnancy

Pregnancy may increase levothyroxine requirements (see PREGNANCY).

Subclinical Hypothyroidism

If this condition is treated, a lower levothyroxine sodium dose (e.g., 1 mcg/kg/day) than that used for full replacement may be adequate to normalize the serum TSH level. Patients who are not treated should be monitored yearly for changes in clinical status and thyroid laboratory parameters.

TSH Suppression in Well-differentiated Thyroid Cancer and Thyroid Nodules

The target level for TSH suppression in these conditions has not been established with controlled studies. In addition, the efficacy of TSH suppression for benign nodular disease is controversial. Therefore, the dose of LEVOXYL used for TSH suppression should be individualized based on the specific disease and the patient being treated.

In the treatment of well differentiated (papillary and follicular) thyroid cancer, levothyroxine is used as an adjunct to surgery and radioiodine therapy. Generally, TSH is suppressed to <0.1 mU/L, and this usually requires a levothyroxine sodium dose of greater than 2 mcg/kg/day. However, in patients with high-risk tumors, the target level for TSH suppression may be <0.01 mU/L.

In the treatment of benign nodules and nontoxic multinodular goiter, TSH is generally suppressed to a higher target (e.g., 0.1—0.5 mU/L for nodules and 0.5—1.0 mU/L for multinodular goiter) than that used for the treatment of thyroid cancer. Levothyroxine sodium is contraindicated if the serum TSH is already suppressed due to the risk of precipitating overt thyrotoxicosis (see CONTRAINDICATIONS , WARNINGS and PRECAUTIONS).

Myxedema Coma

Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Therefore, oral thyroid hormone drug products are not recommended to treat this condition. Thyroid hormone products formulated for intravenous administration should be administered.

HOW SUPPLIED

– LEVOXYL(levothyroxine sodium tablets, USP) are supplied as oval, color-coded, potency marked tablets in 11 strengths:

Strength (mcg) Color NDC # for bottles
25 Orange 30’s NDC 54868-4087-1
50 White 30’s NDC 54868-4092-290’s NDC 54868-4092-1
75 Purple 30’s NDC 54868-4534-190’s NDC 54868-4534-2
88 Olive 30’s NDC 54868-4177-190’s NDC 54868-4177-2
100 Yellow 30’s NDC 54868-4176-190’s NDC 54868-4176-2
112 Rose 30’s NDC 54868-3849-1
125 Brown 20’s NDC 54868-4536-230’s NDC 54868-4536-1100’s NDC 54868-4536-0
150 Blue 30’s NDC 54868-4535-1

STORAGE CONDITIONS

20°—25°C (68°—77°F) with excursions permitted between 15°—30°C (59°—86°F).

Meets USP Dissolution Tests 1 and 2.

Rx ONLY

Manufactured and Distributed by:

King Pharmaceuticals, Inc.
Bristol, TN 37620

Prescribing Information as of August 2008

3001143

Distributed by:
Physicians Total Care, Inc.
Tuisa, OK 74146

PRINCIPAL DISPLAY PANEL — 25 mcg Tablet Bottle Label

LEVOXYL ® (levothyroxine sodium tablets, USP)

25 mcg

Rx only

PRINCIPAL DISPLAY PANEL -- 25 mcg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mcg Tablet Bottle Label

LEVOXYL ® (levothyroxine sodium tablets, USP)

50 mcg

Rx only

PRINCIPAL DISPLAY PANEL -- 50 mcg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mcg Tablet Bottle Label

LEVOXYL ® (levothyroxine sodium tablets, USP)

75 mcg

Rx only

PRINCIPAL DISPLAY PANEL -- 75 mcg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 88 mcg Tablet Bottle Label

LEVOXYL ® (levothyroxine sodium tablets, USP)

88 mcg

Rx only

PRINCIPAL DISPLAY PANEL -- 88 mcg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mcg Tablet Bottle Label

LEVOXYL ® (levothyroxine sodium tablets, USP)

100 mcg

Rx only

PRINCIPAL DISPLAY PANEL -- 100 mcg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 112 mcg Tablet Bottle Label

LEVOXYL ® (levothyroxine sodium tablets, USP)

112 mcg

Rx only

PRINCIPAL DISPLAY PANEL -- 112 mcg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 125 mcg Tablet Bottle Label

LEVOXYL ® (levothyroxine sodium tablets, USP)

125 mcg

Rx only

PRINCIPAL DISPLAY PANEL -- 125 mcg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 150 mcg Tablet Bottle Label

LEVOXYL ® (levothyroxine sodium tablets, USP)

150 mcg

Rx only

PRINCIPAL DISPLAY PANEL -- 150 mcg Tablet Bottle Label
(click image for full-size original)
LEVOXYL levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4087(NDC:60793-850)
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
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CALCIUM SULFATE DIHYDRATE
SODIUM BICARBONATE
FD&C Yellow No. 6
Product Characteristics
Color ORANGE Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code Levoxyl;dp;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4087-1 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021301 06/20/2003
LEVOXYL levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4092(NDC:60793-851)
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
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CALCIUM SULFATE DIHYDRATE
SODIUM BICARBONATE
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code Levoxyl;dp;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4092-1 90 TABLET in 1 BOTTLE None
2 NDC:54868-4092-2 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021301 11/15/2002
LEVOXYL levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4534(NDC:60793-852)
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
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CALCIUM SULFATE DIHYDRATE
SODIUM BICARBONATE
FD&C BLUE NO. 1
D&C RED NO. 30
Product Characteristics
Color PURPLE Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code Levoxyl;dp;75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4534-1 30 TABLET in 1 BOTTLE None
2 NDC:54868-4534-2 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021301 08/03/2001
LEVOXYL levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4177(NDC:60793-853)
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
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CALCIUM SULFATE DIHYDRATE
SODIUM BICARBONATE
FD&C Yellow No. 6
FD&C BLUE NO. 1
D&C YELLOW NO. 10
Product Characteristics
Color GREEN (Olive) Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code Levoxyl;dp;88
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4177-1 30 TABLET in 1 BOTTLE None
2 NDC:54868-4177-2 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021301 05/10/2000
LEVOXYL levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4176(NDC:60793-854)
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
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CALCIUM SULFATE DIHYDRATE
SODIUM BICARBONATE
FD&C Yellow No. 6
D&C YELLOW NO. 10
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code Levoxyl;dp;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4176-1 30 TABLET in 1 BOTTLE None
2 NDC:54868-4176-2 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021301 08/03/2001
LEVOXYL levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-3849(NDC:60793-855)
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
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CALCIUM SULFATE DIHYDRATE
SODIUM BICARBONATE
FD&C Yellow No. 6
FD&C RED NO. 40
D&C RED NO. 30
Product Characteristics
Color PINK (ROSE) Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code Levoxyl;dp;112
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-3849-1 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021301 08/29/1996
LEVOXYL levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4536(NDC:60793-856)
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
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CALCIUM SULFATE DIHYDRATE
SODIUM BICARBONATE
FD&C RED NO. 40
D&C YELLOW NO. 10
Product Characteristics
Color BROWN Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code Levoxyl;dp;125
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4536-0 100 TABLET in 1 BOTTLE None
2 NDC:54868-4536-1 30 TABLET in 1 BOTTLE None
3 NDC:54868-4536-2 10 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021301 12/11/2001
LEVOXYL levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4535(NDC:60793-858)
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
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CALCIUM SULFATE DIHYDRATE
SODIUM BICARBONATE
FD&C BLUE NO. 1
D&C RED NO. 30
Product Characteristics
Color BLUE Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code Levoxyl;dp;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4535-1 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021301 08/22/2001
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel (54868-4087), repack (54868-4087), relabel (54868-4092), repack (54868-4092), relabel (54868-4534), repack (54868-4534), relabel (54868-4177), repack (54868-4177), relabel (54868-4176), repack (54868-4176), relabel (54868-3849), repack (54868-3849), relabel (54868-4536), repack (54868-4536), relabel (54868-4535), repack (54868-4535)

Revised: 08/2013 Physicians Total Care, Inc.

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