FDA.reportPublic FDA data

Atenolol

Product NDC
43353-833
11-digit product format
433530833
Labeler code
43353
Product ID
43353-833_dac66f7f-c5e7-4781-a1d1-540604e87d76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074056
Marketing category
ANDA
Marketing start
2004-11-16
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
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-833IInactivated by FDA2026-08-03
excluded packagepackage43353-83343353-833-30IInactivated by FDA2026-08-03
excluded packagepackage43353-83343353-833-45IInactivated by FDA2026-08-03
excluded packagepackage43353-83343353-833-60IInactivated by FDA2026-08-03
excluded packagepackage43353-83343353-833-80IInactivated by FDA2026-08-03
excluded packagepackage43353-83343353-833-92IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074056-001ATENOLOLATENOLOL50MGTABLET / ORALAB1995-01-18
A074056-002ATENOLOLATENOLOL100MGTABLET / ORALAB1995-01-18
A074056-003ATENOLOLATENOLOL25MGTABLET / ORALAB2004-07-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A074056-001AB
A074056-002AB
A074056-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18a50c72e98297…
2026-08-01 22:54:322026-06A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18a50c72e98297…
2026-08-01 22:54:322026-06A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A074056-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A074056-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A074056-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLQPharma, Inc.70d7a585-7a46-4eac-b2b5-2ac5b98d98822025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.95761173-1c95-46b2-a08f-fbc3e70daba82025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.c69b8e5e-c7c3-4883-9cea-f7f435a8ede82025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLAphena Pharma Solutions - Tennessee, LLC23e96396-85d3-0d8e-e063-6394a90a614d2024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLAphena Pharma Solutions - Tennessee, LLC247569d6-9a73-f1d0-e063-6394a90a667a2024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLNuCare Pharmaceuticals,Inc.7366c6f8-4cb3-520e-e053-2991aa0a2cc82024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLTeva Pharmaceuticals USA, Inc.25a72ec9-de0f-44e5-90b8-da1aab0d35882024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLA-S Medication Solutionsd73a475a-c8c9-44a0-89ac-6a2d665c0d242023-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLProficient Rx LP24f1f3f4-bbda-458b-b15f-d942c90534e22022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLBryant Ranch Prepackba0b0221-d4b3-4cb1-9435-53a75fcc4b402020-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLProficient Rx LPb198b34c-861a-4b52-b4df-8c48b807520a2020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056

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
43353-833-302020-01-31C16284748780-19d75b9cf-f7c7-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753
43353-833-452020-01-31C16284748780-19d75b9cf-f7c7-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753
43353-833-602020-01-31C16284748780-19d75b9cf-f7c7-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753
43353-833-802020-01-31C16284748780-19d75b9cf-f7c7-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753
43353-833-922020-01-31C16284748780-19d75b9cf-f7c7-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-833-30Atenolol30 in 1 BOTTLE, PLASTICTABLET301
43353-833-45Atenolol45 in 1 BOTTLE, PLASTICTABLET451
43353-833-60Atenolol90 in 1 BOTTLE, PLASTICTABLET901
43353-833-80Atenolol180 in 1 BOTTLE, PLASTICTABLET1801
43353-833-92Atenolol270 in 1 BOTTLE, PLASTICTABLET2701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-833-30EA - Each43353-83352d55d72-89e1-4e74-865b-1392dab3e9de12014-06-03
43353-833-45EA - Each43353-83384285309-969d-4b4e-bca4-db15e02a8dfc12014-06-03
43353-833-60EA - Each43353-8336290f125-196b-482e-8af8-8884a4ae870912014-06-03
43353-833-80EA - Each43353-8339687c1b8-9ca7-44b6-9ca2-a7d38647d70e12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-833ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 5 package rows20140516_c53a6028-840e-4e24-9c4e-d487782e0a20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197380atenolol 25 MG Oral TabletPSNc53a6028-840e-4e24-9c4e-d487782e0a201
197380atenolol 25 MG Oral TabletSCDc53a6028-840e-4e24-9c4e-d487782e0a201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-833-304335308333030 in 1 BOTTLE, PLASTICHistorical
43353-833-454335308334545 in 1 BOTTLE, PLASTICHistorical
43353-833-604335308336090 in 1 BOTTLE, PLASTICHistorical
43353-833-8043353083380180 in 1 BOTTLE, PLASTICHistorical
43353-833-9243353083392270 in 1 BOTTLE, PLASTICHistorical