Losartan Potassium and Hydrochlorothiazide (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

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LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE losartan potassium and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-1916(NDC:65862-470)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM (LOSARTAN) LOSARTAN POTASSIUM 100 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TITANIUM DIOXIDE
D&C YELLOW NO. 10
Product Characteristics
Color yellow Score no score
Shape OVAL (Beveled Edge, Biconvex) Size 17mm
Flavor Imprint Code E;49
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-1916-9 90 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68071-1916-3 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091629 10/06/2010
Labeler — NuCare Pharmaceuticals, Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals, Inc. 010632300 repack (68071-1916)

Revised: 01/2022 NuCare Pharmaceuticals, Inc.

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