Atenolol

Product NDC
60760-787
11-digit product format
607600787
Labeler code
60760
Product ID
60760-787_be648303-8e2c-ac0d-e053-2a95a90a821d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
St Mary's Medical Park Pharmacy
Application
ANDA074056
Marketing category
ANDA
Marketing start
2021-03-25
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60760-787DDiscontinued by firm2026-08-17
excluded packagepackage60760-78760760-787-90DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-181e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074056-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074056-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074056-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074056-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074056-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074056-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074056-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074056-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074056-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074056-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074056-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074056-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074056-001AB11e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-787-90EA - Each60760-787f09aba5e-0bbe-41c1-8ac1-cc1b4bbed88412021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-787ATENOLOL TABLET [ST MARY'S MEDICAL PARK PHARMACY]1Legacy NDC20210331_be644f8b-69c3-eef4-e053-2a95a90af51e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-787-906076007879090 TABLET in 1 BOTTLE, PLASTIC (60760-787-90) 90 tablet2021-03-250000-00-00NoNoCurrent