Atenolol

Product NDC
53217-365
11-digit product format
532170365
Labeler code
53217
Product ID
53217-365_4e3a0f8f-5fb4-424d-a702-8d757820b9f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076900
Marketing category
ANDA
Marketing start
2018-02-02
Marketing end
0000-00-00
Substance
ATENOLOL
Active strength
50 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#

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 productproduct53217-365IInactivated by FDA2026-08-03
excluded packagepackage53217-36553217-365-30IInactivated by FDA2026-08-03

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53217-365-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53217-365-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53217-365-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53217-365-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53217-365-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53217-365-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53217-365-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53217-365-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53217-365-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53217-365-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53217-365-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53217-365-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53217-365-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53217-365-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53217-365-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53217-365-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53217-365-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53217-365-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53217-365-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53217-365-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53217-365-309bebd1f3094a…5416666fcb17…

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
A076900-001ATENOLOLATENOLOL25MGTABLET / ORALAB2005-01-28
A076900-002ATENOLOLATENOLOL50MGTABLET / ORALAB2005-01-28
A076900-003ATENOLOLATENOLOL100MGTABLET / ORALAB2005-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076900-001AB
A076900-002AB
A076900-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076900-002ATENOLOL50MGTABLET / ORALAB2005-01-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076900-003ATENOLOL100MGTABLET / ORALAB2005-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076900-001ATENOLOL25MGTABLET / ORALAB2005-01-288072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076900-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076900-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076900-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076900-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076900-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076900-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076900-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076900-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076900-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076900-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076900-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076900-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076900-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076900-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076900-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076900-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076900-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076900-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076900-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076900-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076900-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076900-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076900-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076900-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076900-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076900-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076900-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076900-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076900-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076900-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076900-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076900-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076900-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076900-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076900-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076900-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076900-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076900-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076900-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076900-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
5eb1a708-d713-e905-0a08-b103c64796f4Product name320201019
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-365-302020-01-31C16284748780-19d75b9d0-0aff-f424-e053-dadaa90a57ceAtenolol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-365-30Atenolol30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-365ATENOLOL TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180821_37ddfad4-5234-4149-b1c9-f4e8cb802243.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLA-S Medication Solutionsb6fe1a12-a6d5-4c4c-9d77-6f717b43f8fe2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076900
application number: ANDA076900
AtenololATENOLOLA-S Medication Solutionsd21f2b4d-6584-48e5-8045-e5927ba033292026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076900
application number: ANDA076900
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.8acdb229-928b-4c22-88f1-f4dd97cde2742025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076900
application number: ANDA076900
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.bdbf6779-8e9b-4ce1-a361-ede4914dd2f32025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076900
application number: ANDA076900
AtenololATENOLOLAmerican Health Packagingd19e9fcf-dfa1-43d7-94dc-e3f03fb90f5c2024-12-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076900
application number: ANDA076900
AtenololATENOLOLZydus Lifesciences Limited2492d5f6-00b0-42c9-a793-2be83ea81ad12024-11-25Exact identifier
application applno (ANDA): 076900
application number: ANDA076900
AtenololATENOLOLNuCare Pharmaceuticals, Inc.3d70576a-6fa7-481d-e054-00144ff88e882024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076900
application number: ANDA076900
AtenololATENOLOLBryant Ranch Prepack67d9ca94-2af6-4ebb-a5c3-8d360f7412772024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076900
application number: ANDA076900
AtenololATENOLOLZydus Pharmaceuticals USA Inc.db801706-1362-44c7-92ab-f584f96c7e1c2024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076900
application number: ANDA076900

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197381atenolol 50 MG Oral TabletPSN37ddfad4-5234-4149-b1c9-f4e8cb8022431
197381atenolol 50 MG Oral TabletSCD37ddfad4-5234-4149-b1c9-f4e8cb8022431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-365-305321703653030 in 1 BOTTLEHistorical