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NDC 65841-0022-01 Atenolol 25 mg/1 Details

Atenolol 25 mg/1

Atenolol is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Lifesciences Limited. The primary component is ATENOLOL.

MedlinePlus Drug Summary

Atenolol is used alone or in combination with other medications to treat high blood pressure. It also is used to prevent angina (chest pain) and improve survival after a heart attack. Atenolol is in a class of medications called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

Related Packages: 65841-0022-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Atenolol

Product Information

NDC	65841-0022
Product ID	65841-022_dcaaa30b-389f-4409-8c25-8e1b9a1e76cc
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Atenolol
Proprietary Name Suffix	n/a
Non-Proprietary Name	Atenolol
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	ATENOLOL
Labeler Name	Zydus Lifesciences Limited
Pharmaceutical Class	Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076900
Listing Certified Through	2024-12-31

Package

Package Images

NDC 65841-0022-01 (65841002201)

Pricing Information	N/A
NDC Package Code	65841-022-01
Billing NDC	65841002201
Package	100 TABLET in 1 BOTTLE (65841-022-01)
Marketing Start Date	2005-10-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2492d5f6-00b0-42c9-a793-2be83ea81ad1 Details

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-022-01 in bottles of 100 tablets

Atenolol Tablets USP, 25 mg

Rx only

100 Tablets

NDC 65841-023-01 in bottles of 100 tablets

Atenolol Tablets USP, 50 mg

Rx only

100 Tablets

NDC 65841-024-01 in bottles of 100 tablets

Atenolol Tablets USP, 100 mg

Rx only

100 Tablets

INGREDIENTS AND APPEARANCE

ATENOLOL

atenolol tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-022
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI)	ATENOLOL	25 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE (WHITE TO OFF- WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	Z;65
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-022-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2005
2	NDC:65841-022-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2005
3	NDC:65841-022-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2005
4	NDC:65841-022-40	5000 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2005
5	NDC:65841-022-24	10000 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2005

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI)	ATENOLOL	50 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE (WHITE TO OFF- WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	8mm
Flavor		Imprint Code	Z;66
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-023-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2005
2	NDC:65841-023-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2005
3	NDC:65841-023-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2005
4	NDC:65841-023-02	2000 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2005
5	NDC:65841-023-40	5000 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2005
6	NDC:65841-023-24	10000 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2005

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATENOLOL (UNII: 50VV3VW0TI) (ATENOLOL - UNII:50VV3VW0TI)	ATENOLOL	100 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE (WHITE TO OFF- WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	Z;67
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-024-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2005
2	NDC:65841-024-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2005
3	NDC:65841-024-40	5000 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2005
4	NDC:65841-024-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2005

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076900	10/08/2005

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-022, 65841-023, 65841-024) , MANUFACTURE(65841-022, 65841-023, 65841-024)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		677605858	ANALYSIS(65841-022, 65841-023, 65841-024) , MANUFACTURE(65841-022, 65841-023, 65841-024)

Revised: 8/2022

Document Id: dcaaa30b-389f-4409-8c25-8e1b9a1e76cc

Set id: 2492d5f6-00b0-42c9-a793-2be83ea81ad1

Version: 9

Effective Time: 20220803

Search by Drug Name or NDC

NDC 65841-0022-01 Atenolol 25 mg/1 Details

Atenolol 25 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 65841-0022-01 (65841002201)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 2492d5f6-00b0-42c9-a793-2be83ea81ad1 Details

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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