FDA.reportPublic FDA data

Atenolol

Product NDC
63187-710
11-digit product format
631870710
Labeler code
63187
Product ID
63187-710_6144c77d-0600-4b23-9a4a-4f93332871e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074056
Marketing category
ANDA
Marketing start
1995-02-22
Substance
ATENOLOL
Active strength
50 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
ndc (product): 63187-710

Additional Listing Data#

Finished product
Yes
Brand name base
Atenolol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATENOLOL50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
50VV3VW0TIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197381Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b198b34c-861a-4b52-b4df-8c48b807520aAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-710-30Atenolol30 in 1 BOTTLETABLET304
63187-710-60Atenolol60 in 1 BOTTLETABLET604
63187-710-90Atenolol90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-710ATENOLOL TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20200218_b198b34c-861a-4b52-b4df-8c48b807520a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197381atenolol 50 MG Oral TabletPSNb198b34c-861a-4b52-b4df-8c48b807520a4
197381atenolol 50 MG Oral TabletSCDb198b34c-861a-4b52-b4df-8c48b807520a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-710-306318707103030 TABLET in 1 BOTTLE (63187-710-30) 30 tablet2016-06-010000-00-00NoNoCurrent
63187-710-606318707106060 TABLET in 1 BOTTLE (63187-710-60) 60 tablet2016-06-010000-00-00NoNoCurrent
63187-710-906318707109090 TABLET in 1 BOTTLE (63187-710-90) 90 tablet2016-06-010000-00-00NoNoCurrent