Atenolol and Chlorthalidone: Package Insert and Label Information

ATENOLOL AND CHLORTHALIDONE — atenolol and chlorthalidone tablet
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1372-1

Atenolol and Chlorthalidone Tablets, USP 50 mg/25 mg

Rx only

100 Tablets

Atenolol and Chlorthalidon Tablets, USP
(click image for full-size original)

NDC 70771-1373-1

Atenolol and Chlorthalidone Tablets, USP 100 mg/25 mg

Rx only

100 Tablets

Atenolol and Chlorthalidon Tablets, USP
(click image for full-size original)
ATENOLOL AND CHLORTHALIDONE
atenolol and chlorthalidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1372
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATENOLOL (ATENOLOL) ATENOLOL 50 mg
CHLORTHALIDONE (CHLORTHALIDONE) CHLORTHALIDONE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
STARCH, CORN
Product Characteristics
Color WHITE (WHITE TO OFF WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code 11;67
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1372-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210028 03/12/2019
ATENOLOL AND CHLORTHALIDONE
atenolol and chlorthalidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1373
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATENOLOL (ATENOLOL) ATENOLOL 100 mg
CHLORTHALIDONE (CHLORTHALIDONE) CHLORTHALIDONE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
STARCH, CORN
Product Characteristics
Color WHITE (WHITE TO OFF WHITE) Score no score
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code 11;68
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1373-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210028 03/12/2019
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 863362789 ANALYSIS (70771-1372), ANALYSIS (70771-1373), MANUFACTURE (70771-1372), MANUFACTURE (70771-1373)

Revised: 08/2022 Zydus Lifesciences Limited

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