FDA.reportPublic FDA data

Atenolol

Product NDC
75834-281
11-digit product format
758340281
Labeler code
75834
Product ID
75834-281_af3cca55-4c04-4381-9827-20016b2e4bef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA073026
Marketing category
ANDA
Marketing start
2022-12-19
Marketing end
0000-00-00
Substance
ATENOLOL
Active strength
25 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
5eb1a708-d713-e905-0a08-b103c64796f4Product name320201019

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75834-281-102026-01-29C16284748780-149896155-be4c-586f-e063-e6dba90add90Atenolol Tablets, USP
75834-281-002024-02-09C16284748780-11030e364-f997-111a-e063-dadaa90a10e2Atenolol Tablets, USP
75834-281-012024-02-09C16284748780-11030e364-f997-111a-e063-dadaa90a10e2Atenolol Tablets, USP
75834-281-002024-01-30C16284748780-11030e364-f997-111a-e063-dadaa90a10e2Atenolol Tablets, USP
75834-281-012024-01-30C16284748780-11030e364-f997-111a-e063-dadaa90a10e2Atenolol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-281-00Atenolol1000 in 1 BOTTLETABLET10002
75834-281-01Atenolol100 in 1 BOTTLETABLET1002
75834-281-10Atenolol1 in 1 DRUMTABLET11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-281-00EA - Each75834-2810cae8390-10a7-4a5f-a53b-77ca6fa1b28f12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-281ATENOLOL TABLET [NIVAGEN PHARMACEUTICALS, INC.]2Legacy NDC, 2 package rows20240210_af3cca55-4c04-4381-9827-20016b2e4bef.zip
75834-281ATENOLOL TABLET [NIVAGEN PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20240724_bc9b6990-4e55-4c6e-ab61-fdb207b15df5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197380atenolol 25 MG Oral TabletPSN79490e9f-bbed-4e8f-b640-7d218741303a100
197380atenolol 25 MG Oral TabletSCD79490e9f-bbed-4e8f-b640-7d218741303a100
197379atenolol 100 MG Oral TabletPSNaf3cca55-4c04-4381-9827-20016b2e4bef2
197380atenolol 25 MG Oral TabletPSNaf3cca55-4c04-4381-9827-20016b2e4bef2
197381atenolol 50 MG Oral TabletPSNaf3cca55-4c04-4381-9827-20016b2e4bef2
197379atenolol 100 MG Oral TabletSCDaf3cca55-4c04-4381-9827-20016b2e4bef2
197380atenolol 25 MG Oral TabletSCDaf3cca55-4c04-4381-9827-20016b2e4bef2
197381atenolol 50 MG Oral TabletSCDaf3cca55-4c04-4381-9827-20016b2e4bef2
197379atenolol 100 MG Oral TabletPSNbc9b6990-4e55-4c6e-ab61-fdb207b15df51
197380atenolol 25 MG Oral TabletPSNbc9b6990-4e55-4c6e-ab61-fdb207b15df51
197381atenolol 50 MG Oral TabletPSNbc9b6990-4e55-4c6e-ab61-fdb207b15df51
197379atenolol 100 MG Oral TabletSCDbc9b6990-4e55-4c6e-ab61-fdb207b15df51
197380atenolol 25 MG Oral TabletSCDbc9b6990-4e55-4c6e-ab61-fdb207b15df51
197381atenolol 50 MG Oral TabletSCDbc9b6990-4e55-4c6e-ab61-fdb207b15df51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-281-00758340281001000 TABLET in 1 BOTTLE (75834-281-00) 1000 tablet2022-12-190000-00-00NoNoCurrent
75834-281-0175834028101100 TABLET in 1 BOTTLE (75834-281-01) 100 tablet2022-12-190000-00-00NoNoCurrent
75834-281-10758340281101 in 1 DRUMHistorical