Hydrochlorothiazide (Page 3 of 3)

PRINCIPAL DISPLAY PANEL

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Hydrochlorothiazide Tablets USP 25 mg

Container Label
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Hydrochlorothiazide Tablets USP 50 mg

HYDROCHLOROTHIAZIDE
hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-128
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SILICON DIOXIDE
STARCH, CORN
Product Characteristics
Color ORANGE (Light Orange) Score 2 pieces
Shape ROUND (Round) Size 7mm
Flavor Imprint Code U;128
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29300-128-01 100 TABLET in 1 BOTTLE None
2 NDC:29300-128-05 500 TABLET in 1 BOTTLE None
3 NDC:29300-128-10 1000 TABLET in 1 BOTTLE None
4 NDC:29300-128-50 5000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040907 08/15/2008
HYDROCHLOROTHIAZIDE
hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-129
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SILICON DIOXIDE
STARCH, CORN
Product Characteristics
Color ORANGE (Light Orange) Score 2 pieces
Shape ROUND (Round) Size 8mm
Flavor Imprint Code U;129
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29300-129-01 100 TABLET in 1 BOTTLE None
2 NDC:29300-129-05 500 TABLET in 1 BOTTLE None
3 NDC:29300-129-10 1000 TABLET in 1 BOTTLE None
4 NDC:29300-129-50 5000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040907 08/15/2008
Labeler — Unichem Pharmaceuticals (USA), Inc. (181620514)

Revised: 11/2019 Unichem Pharmaceuticals (USA), Inc.

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