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 — 50 mcg Tablet Bottle Label

LEVOXYL ^® (levothyroxine sodium tablets, USP)

50 mcg

Rx only

PRINCIPAL DISPLAY PANEL — 75 mcg Tablet Bottle Label

LEVOXYL ^® (levothyroxine sodium tablets, USP)

75 mcg

Rx only

PRINCIPAL DISPLAY PANEL — 88 mcg Tablet Bottle Label

LEVOXYL ^® (levothyroxine sodium tablets, USP)

88 mcg

Rx only

PRINCIPAL DISPLAY PANEL — 100 mcg Tablet Bottle Label

LEVOXYL ^® (levothyroxine sodium tablets, USP)

100 mcg

Rx only

PRINCIPAL DISPLAY PANEL — 112 mcg Tablet Bottle Label

LEVOXYL ^® (levothyroxine sodium tablets, USP)

112 mcg

Rx only

PRINCIPAL DISPLAY PANEL — 125 mcg Tablet Bottle Label

LEVOXYL ^® (levothyroxine sodium tablets, USP)

125 mcg

Rx only

PRINCIPAL DISPLAY PANEL — 150 mcg Tablet Bottle Label

LEVOXYL ^® (levothyroxine sodium tablets, USP)

150 mcg

Rx only

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.