LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (Page 5 of 5)

PACKAGE LABEL -LOSARTAN POTASSIUM HCTZ 100 / 25 MG TABLET

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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:16590-954(NDC:13668-118)
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
HYPROMELLOSES
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
TITANIUM DIOXIDE
D&C YELLOW NO. 10
Product Characteristics
Color yellow Score no score
Shape OVAL (OVAL SHAPED, BICONVEX FILM COATED TABLAETS) Size 16mm
Flavor Imprint Code 1118
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-954-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:16590-954-60 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:16590-954-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090528 10/06/2010
Labeler — STAT RX USA LLC (786036330)
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC 786036330 relabel, repack

Revised: 07/2011 STAT RX USA LLC

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