FDA.reportPublic FDA data

Atenolol

Product NDC
50090-3411
11-digit product format
500903411
Labeler code
50090
Product ID
50090-3411_ccb16e07-c3fd-4516-9e1a-3535ebed0913
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
2021-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3411DDiscontinued by firm2026-08-03
excluded packagepackage50090-341150090-3411-0DDiscontinued by firm2026-08-03
excluded packagepackage50090-341150090-3411-2DDiscontinued by firm2026-08-03
excluded packagepackage50090-341150090-3411-4DDiscontinued by firm2026-08-03
excluded packagepackage50090-341150090-3411-5DDiscontinued by firm2026-08-03

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3411-02023-12-22C16284748780-1f386c649-c669-0266-e053-dadaa90a7c1aATENOLOL TABLETS USP 0787 0752 0753 Rx only
50090-3411-22023-12-22C16284748780-1f386c649-c669-0266-e053-dadaa90a7c1aATENOLOL TABLETS USP 0787 0752 0753 Rx only
50090-3411-42023-12-22C16284748780-1f386c649-c669-0266-e053-dadaa90a7c1aATENOLOL TABLETS USP 0787 0752 0753 Rx only
50090-3411-52023-12-22C16284748780-1f386c649-c669-0266-e053-dadaa90a7c1aATENOLOL TABLETS USP 0787 0752 0753 Rx only
50090-3411-02023-01-30C16284748780-1f386c649-c669-0266-e053-dadaa90a7c1aATENOLOL TABLETS USP 0787 0752 0753 Rx only
50090-3411-22023-01-30C16284748780-1f386c649-c669-0266-e053-dadaa90a7c1aATENOLOL TABLETS USP 0787 0752 0753 Rx only
50090-3411-42023-01-30C16284748780-1f386c649-c669-0266-e053-dadaa90a7c1aATENOLOL TABLETS USP 0787 0752 0753 Rx only
50090-3411-52023-01-30C16284748780-1f386c649-c669-0266-e053-dadaa90a7c1aATENOLOL TABLETS USP 0787 0752 0753 Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3411-0EA - Each50090-341162c0f446-69fc-492c-a28b-ebf0b416420312021-09-07
50090-3411-2EA - Each50090-3411da12fcb8-a62c-4b38-b427-45f154f849db12021-09-07
50090-3411-4EA - Each50090-3411f93f987a-ee9f-4edc-9a7a-a792d016231e12019-05-02
50090-3411-5EA - Each50090-3411971955ae-b27f-4cc5-b517-9716167b62fb12019-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3411-05009034110030 TABLET in 1 BOTTLE, PLASTIC (50090-3411-0) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-3411-250090341102100 TABLET in 1 BOTTLE, PLASTIC (50090-3411-2) 100 tablet2014-11-280000-00-00NoNoCurrent
50090-3411-450090341104200 TABLET in 1 BOTTLE (50090-3411-4) 200 tablet2018-03-270000-00-00NoNoCurrent
50090-3411-55009034110590 TABLET in 1 BOTTLE (50090-3411-5) 90 tablet2018-03-220000-00-00NoNoCurrent