Atenolol

ATENOLOL- atenolol tablet
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-022-01 in bottles of 100 tablets

Atenolol Tablets USP, 25 mg

Rx only

100 Tablets

Atenolol Tablets, 25 mg
(click image for full-size original)

NDC 65841-023-01 in bottles of 100 tablets

Atenolol Tablets USP, 50 mg

Rx only

100 Tablets

Atenolol Tablets, 50 mg
(click image for full-size original)

NDC 65841-024-01 in bottles of 100 tablets

Atenolol Tablets USP, 100 mg

Rx only

100 Tablets

Atenolol Tablets, 100 mg
(click image for full-size original)
ATENOLOL
atenolol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-022
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATENOLOL (ATENOLOL) ATENOLOL 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
POVIDONE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF- WHITE) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code Z;65
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-022-16 90 TABLET in 1 BOTTLE None
2 NDC:65841-022-01 100 TABLET in 1 BOTTLE None
3 NDC:65841-022-10 1000 TABLET in 1 BOTTLE None
4 NDC:65841-022-40 5000 TABLET in 1 BOTTLE None
5 NDC:65841-022-24 10000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076900 10/08/2005
ATENOLOL
atenolol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-023
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATENOLOL (ATENOLOL) ATENOLOL 50 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
POVIDONE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF- WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code Z;66
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-023-16 90 TABLET in 1 BOTTLE None
2 NDC:65841-023-01 100 TABLET in 1 BOTTLE None
3 NDC:65841-023-10 1000 TABLET in 1 BOTTLE None
4 NDC:65841-023-02 2000 TABLET in 1 BOTTLE None
5 NDC:65841-023-40 5000 TABLET in 1 BOTTLE None
6 NDC:65841-023-24 10000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076900 10/08/2005
ATENOLOL
atenolol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-024
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATENOLOL (ATENOLOL) ATENOLOL 100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
POVIDONE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (WHITE TO OFF- WHITE) Score no score
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code Z;67
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-024-01 100 TABLET in 1 BOTTLE None
2 NDC:65841-024-10 1000 TABLET in 1 BOTTLE None
3 NDC:65841-024-40 5000 TABLET in 1 BOTTLE None
4 NDC:65841-024-16 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076900 10/08/2005
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-022), ANALYSIS (65841-023), ANALYSIS (65841-024), MANUFACTURE (65841-022), MANUFACTURE (65841-023), MANUFACTURE (65841-024)
Establishment
Name Address ID/FEI Operations
CADILA HEALTHCARE LIMITED 677605858 ANALYSIS (65841-022), ANALYSIS (65841-023), ANALYSIS (65841-024), MANUFACTURE (65841-022), MANUFACTURE (65841-023), MANUFACTURE (65841-024)

Revised: 07/2020 Cadila Healthcare Limited

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