Losartan Potassium (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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LOSARTAN POTASSIUM losartan potassium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-1518(NDC:13668-115)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
STARCH, PREGELATINIZED CORN
TALC
TITANIUM DIOXIDE
SILICON DIOXIDE
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL (oval shaped, biconvex) Size 13mm
Flavor Imprint Code 100;115
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-1518-3 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090467 10/06/2010
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 relabel (68071-1518)

Revised: 09/2020 NuCare Pharmaceuticals,Inc.

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