ATENOLOL

Product NDC
61919-854
Requested package NDC
61919-854-30
11-digit product format
619190854
Labeler code
61919
Product ID
61919-854_ea4edbaa-3901-bf8c-e053-2995a90a0af1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATENOLOL
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA077443
Marketing category
ANDA
Marketing start
2019-08-14
Marketing end
0000-00-00
Substance
ATENOLOL
Active strength
100 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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61919-85461919-854-30DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A077443-001ATENOLOLATENOLOL25MGTABLET / ORALAB2006-09-13
A077443-002ATENOLOLATENOLOL50MGTABLET / ORALAB2006-09-13
A077443-003ATENOLOLATENOLOL100MGTABLET / ORALAB2006-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077443-001AB
A077443-002AB
A077443-003AB

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 06:07:402026-07A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13caaa826d4ba7…
2026-08-18 06:07:402026-07A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13caaa826d4ba7…
2026-08-18 06:07:402026-07A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-131e350fbaab3a…

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 06:07:402026-07A077443-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077443-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077443-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077443-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077443-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077443-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077443-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077443-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077443-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077443-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077443-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077443-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-001AB11e350fbaab3a…

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
61919-854-902024-01-30C16284748780-1ba0f9c33-4ef2-a910-e053-dadaa90a0b85ATENOLOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-854-90ATENOLOL90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-854-30EA - Each61919-854e6028184-c599-4011-ad46-76a5a84be0e912019-09-05
61919-854-90EA - Each61919-854274e151b-9793-481e-92ce-733db7dce23112019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [DIRECT RX]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [DIRECT RX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [DIRECT RX]1
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAATENOLOL TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JATENOLOL TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJATENOLOL TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-854ATENOLOL TABLET [DIRECT RX]5Legacy NDC, 1 package rows20190430_b002421f-8120-4e76-a9e2-cc356fbc4cff.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLSt. Mary's Medical Park Pharmacy7f8304a4-93de-774f-e053-2a91aa0aa5b52026-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLSt Mary's Medical Park Pharmacy78d394b8-8ffb-a846-e053-2991aa0aa58c2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLSt. Mary's Medical Park Pharmacy8501f6c1-8157-4189-e053-2a91aa0ac4ef2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLPreferred Pharmaceuticals, Inc.26d3df38-20c6-40e0-a456-da4f10fff6322026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLPreferred Pharmaceuticals, Inc.a8d48a47-ccab-4a35-a092-6e562683ade32026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLPreferred Pharmaceuticals Inc.82100fc8-5a5a-4d80-8101-72024ee0abef2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
atenololATENOLOLdirect rxb3c757de-1cbf-61f5-e053-2995a90accfc2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLA-S Medication Solutions43acd912-f0f4-47eb-b81f-cbbfed77c5572026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLA-S Medication Solutionse4ece8f4-3714-42ba-b36d-d00586dfd33a2026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLNorthwind Health Company, LLCdb5bd8e2-1314-0f7f-e053-2995a90ae86e2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLQPharma, Inc.bd43e0b1-c05e-01ae-e053-2a95a90af1cd2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLRising Pharma Holdings, Inc.96dd038f-b363-4e24-9c67-82b7c85c3bc42025-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLNuCare Pharmaceuticals,Inc.8115a2bc-69aa-60b4-e053-2a91aa0aeae72025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLDirect_Rxee143f2f-be60-bc67-e053-2a95a90ae6e62025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
ATENOLOLATENOLOLdirect rxb3d9f826-7ed7-1e3b-e053-2995a90ae7312025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLNuCare Pharmaceuticals,Inc.9db36b04-f353-55d6-e053-2a95a90ae08f2025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLBryant Ranch Prepack722d6532-20d0-4936-ae9c-b7bb593b960a2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLBryant Ranch Prepackc7a8830a-5eda-4f0e-bf03-61ee8ed6558d2024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLBryant Ranch Prepack1d6ea66b-30ef-4829-b757-5ea9d412a6662024-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLNuCare Pharmaceuticals,Inc.73671d55-3e10-cb1d-e053-2991aa0ac0382024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197379atenolol 100 MG Oral TabletPSNb002421f-8120-4e76-a9e2-cc356fbc4cff5
197380atenolol 25 MG Oral TabletPSNb002421f-8120-4e76-a9e2-cc356fbc4cff5
197379atenolol 100 MG Oral TabletSCDb002421f-8120-4e76-a9e2-cc356fbc4cff5
197380atenolol 25 MG Oral TabletSCDb002421f-8120-4e76-a9e2-cc356fbc4cff5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-854-306191908543030 TABLET in 1 BOTTLE (61919-854-30) 30 tablet2019-08-140000-00-00NoNoCurrent