Hydrochlorothiazide (Page 3 of 3)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 25 mg (100 Tablet Bottle)

NDC 65862-133-01
Rx only
Hydrochlorothiazide
Tablets, USP
25 mg AUROBINDO 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 25 mg (100 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 50 mg (100 Tablet Bottle)

NDC 65862-134-01
Rx only
Hydrochlorothiazide
Tablets, USP
50 mg AUROBINDO 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 50 mg (100 Tablet Bottle)
(click image for full-size original)
HYDROCHLOROTHIAZIDE hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-133
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
LACTOSE MONOHYDRATE
STARCH, CORN
FD&C YELLOW NO. 6
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color PINK (Light Pink) Score 2 pieces
Shape ROUND (Flat Faced Beveled Edge) Size 6mm
Flavor Imprint Code D;27
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-133-01 100 TABLET in 1 BOTTLE None
2 NDC:65862-133-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040780 07/20/2007
HYDROCHLOROTHIAZIDE hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-134
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
LACTOSE MONOHYDRATE
STARCH, CORN
FD&C YELLOW NO. 6
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color PINK (Light Pink) Score 2 pieces
Shape ROUND (Flat Faced Beveled Edge) Size 8mm
Flavor Imprint Code D;28
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-134-01 100 TABLET in 1 BOTTLE None
2 NDC:65862-134-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040780 07/20/2007
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (65862-133), ANALYSIS (65862-134), MANUFACTURE (65862-133), MANUFACTURE (65862-134)

Revised: 10/2020 Aurobindo Pharma Limited

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