Chlorthalidone

CHLORTHALIDONE — chlorthalidone tablet
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1369-1

Chlorthalidone tablets USP ,25 mg

Rx only

100 tablets

Chlorthalidone tablets, USP
(click image for full-size original)

NDC 70771-1370-1

Chlorthalidone tablets USP, 50 mg

Rx only

100 tablets

Chlorthalidone tablets, USP
(click image for full-size original)
CHLORTHALIDONE
chlorthalidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1369
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORTHALIDONE (CHLORTHALIDONE) CHLORTHALIDONE 25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
FERRIC OXIDE YELLOW
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
STEARIC ACID
Product Characteristics
Color YELLOW (LIGHT YELLOW) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code Z25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1369-1 100 TABLET in 1 BOTTLE None
2 NDC:70771-1369-0 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207813 05/15/2019
CHLORTHALIDONE
chlorthalidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1370
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORTHALIDONE (CHLORTHALIDONE) CHLORTHALIDONE 50 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
STEARIC ACID
Product Characteristics
Color WHITE (WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code Z;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1370-1 100 TABLET in 1 BOTTLE None
2 NDC:70771-1370-0 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207813 05/15/2019
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 863362789 ANALYSIS (70771-1369), ANALYSIS (70771-1370), MANUFACTURE (70771-1369), MANUFACTURE (70771-1370)

Revised: 08/2022 Zydus Lifesciences Limited

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