Levothyroxine Sodium (Page 6 of 6)

HOW SUPPLIED

Levothyroxine Sodium Tablets, USP are round, color coded, partial bisected tablets debossed with JSP and ID Number:

Strength (mcg) Color NDC# for bottles of 100 NDC# for bottles of 1000
25 Peach NDC 0527-1341-01 NDC 0527-1341 -10
50 White NDC 0527-1342-01 NDC 0527-1342 -10
75 Purple NDC 0527-1343-01 NDC 0527-1343 -10
88 Olive NDC 0527-1344-01 NDC 0527-1344 -10
100 Yellow NDC 0527-1345-01 NDC 0527-1345 -10
112 Rose NDC 0527-1346-01 NDC 0527-1346 -10
125 Tan NDC 0527-1347-01 NDC 0527-1347 -10
137 Blue NDC 0527-1638-01 NDC 0527-1638 -10
150 Lt. Blue NDC 0527-1349-01 NDC 0527-1349 -10
175 Lilac NDC 0527-1350-01 NDC 0527-1350 -10
200 Pink NDC 0527-1351-01 NDC 0527-1351 -10
300 Green NDC 0527-1352-01 NDC 0527-1352 -10

STORAGE CONDITIONS

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

Rx only

Manufactured for:
Lannett Company, Inc.
Philadelphia, PA 19136

Manufactured by:
Jerome Stevens Pharmaceuticals, Inc.
Bohemia, NY 11716

Rev. 10/07

MG #18326

PRINCIPAL DISPLAY PANEL — 200 mcg (0.2 mg)

Levothyroxine Sodium Tablets, USP 200mcg (0.2mg)
30 Tablets
NDC 10544-267-30

0.2mg 30ct
(click image for full-size original)

LEVOTHYROXINE SODIUM levothyroxine sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-267(NDC:0527-1351)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOTHYROXINE SODIUM (LEVOTHYROXINE) LEVOTHYROXINE SODIUM ANHYDROUS 0.2 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
ACACIA
SODIUM STARCH GLYCOLATE TYPE A POTATO
FD&C RED NO. 40
ALUMINUM OXIDE
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code JSP;522
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-267-30 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021210 11/18/2013
Labeler — Blenheim Pharmacal, Inc. (171434587)
Registrant — Blenheim Pharmacal, Inc. (171434587)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 repack (10544-267)

Revised: 12/2015 Blenheim Pharmacal, Inc.

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