Atenolol

Product NDC
66116-401
11-digit product format
661160401
Labeler code
66116
Product ID
66116-401_b8585313-58f6-42af-bab7-e524ccdacd08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA078254
Marketing category
ANDA
Marketing start
2009-11-10
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
E
Listing certified through
2017-12-31
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 productproduct66116-401IInactivated by FDA2026-08-10
excluded packagepackage66116-40166116-401-30IInactivated by FDA2026-08-10

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 · 44 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 packagepackage66116-401-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66116-401-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66116-401-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66116-401-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66116-401-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66116-401-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66116-401-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66116-401-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66116-401-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66116-401-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66116-401-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66116-401-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66116-401-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66116-401-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66116-401-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66116-401-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66116-401-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66116-401-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66116-401-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66116-401-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66116-401-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66116-401-30110d247fa046…a55b01930146…

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
A078254-001ATENOLOLATENOLOL25MGTABLET / ORAL2009-09-25
A078254-002ATENOLOLATENOLOL50MGTABLET / ORAL2009-09-25
A078254-003ATENOLOLATENOLOL100MGTABLET / ORAL2009-09-25

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 UTC2026-02A078254-001ATENOLOL25MGTABLET / ORAL2009-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078254-002ATENOLOL50MGTABLET / ORAL2009-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078254-003ATENOLOL100MGTABLET / ORAL2009-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078254-001ATENOLOL25MGTABLET / ORAL2009-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078254-002ATENOLOL50MGTABLET / ORAL2009-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078254-003ATENOLOL100MGTABLET / ORAL2009-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078254-001ATENOLOL25MGTABLET / ORAL2009-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078254-002ATENOLOL50MGTABLET / ORAL2009-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078254-003ATENOLOL100MGTABLET / ORAL2009-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078254-001ATENOLOL25MGTABLET / ORAL2009-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078254-002ATENOLOL50MGTABLET / ORAL2009-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078254-003ATENOLOL100MGTABLET / ORAL2009-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078254-001ATENOLOL25MGTABLET / ORAL2009-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078254-002ATENOLOL50MGTABLET / ORAL2009-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078254-003ATENOLOL100MGTABLET / ORAL2009-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078254-001ATENOLOL25MGTABLET / ORAL2009-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078254-002ATENOLOL50MGTABLET / ORAL2009-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078254-003ATENOLOL100MGTABLET / ORAL2009-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078254-001ATENOLOL25MGTABLET / ORAL2009-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078254-002ATENOLOL50MGTABLET / ORAL2009-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078254-003ATENOLOL100MGTABLET / ORAL2009-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078254-001ATENOLOL25MGTABLET / ORAL2009-09-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078254-002ATENOLOL50MGTABLET / ORAL2009-09-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078254-003ATENOLOL100MGTABLET / ORAL2009-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078254-001ATENOLOL25MGTABLET / ORAL2009-09-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078254-002ATENOLOL50MGTABLET / ORAL2009-09-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078254-003ATENOLOL100MGTABLET / ORAL2009-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078254-001ATENOLOL25MGTABLET / ORAL2009-09-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078254-002ATENOLOL50MGTABLET / ORAL2009-09-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078254-003ATENOLOL100MGTABLET / ORAL2009-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078254-001ATENOLOL25MGTABLET / ORAL2009-09-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078254-002ATENOLOL50MGTABLET / ORAL2009-09-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078254-003ATENOLOL100MGTABLET / ORAL2009-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078254-001ATENOLOL25MGTABLET / ORAL2009-09-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078254-002ATENOLOL50MGTABLET / ORAL2009-09-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078254-003ATENOLOL100MGTABLET / ORAL2009-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078254-001ATENOLOL25MGTABLET / ORAL2009-09-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078254-002ATENOLOL50MGTABLET / ORAL2009-09-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078254-003ATENOLOL100MGTABLET / ORAL2009-09-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078254-001ATENOLOL25MGTABLET / ORAL2009-09-258072bd15b7f6…

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
66116-401-302019-11-13C16284748780-197449f38-c5b1-f6ea-e053-dbdaa90aa703Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-401-30Atenolol30 in 1 BOTTLETABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AtenololACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [MEDVANTX, INC.]1
AtenololACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [MEDVANTX, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATENOLOL TABLET [MEDVANTX, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-401ATENOLOL TABLET [MEDVANTX, INC.]1Legacy NDC, 1 package rows20111205_b8585313-58f6-42af-bab7-e524ccdacd08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197381atenolol 50 MG Oral TabletPSNb8585313-58f6-42af-bab7-e524ccdacd081
197381atenolol 50 MG Oral TabletSCDb8585313-58f6-42af-bab7-e524ccdacd081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-401-306611604013030 in 1 BOTTLEHistorical