Atenolol

Product NDC
64725-0621
11-digit product format
647250621
Labeler code
64725
Product ID
64725-0621_45ecdad5-5b7b-4eb4-b8b0-f89d02ad60e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA077877
Marketing category
ANDA
Marketing start
2007-12-04
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
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 productproduct64725-0621IInactivated by FDA2026-08-03
excluded packagepackage64725-062164725-0621-1IInactivated 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 · 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 packagepackage64725-0621-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64725-0621-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64725-0621-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64725-0621-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64725-0621-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64725-0621-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64725-0621-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64725-0621-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64725-0621-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64725-0621-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64725-0621-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64725-0621-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64725-0621-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64725-0621-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64725-0621-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64725-0621-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64725-0621-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64725-0621-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64725-0621-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage64725-0621-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage64725-0621-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage64725-0621-1110d247fa046…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
A077877-001ATENOLOLATENOLOL25MGTABLET / ORALAB2006-12-27
A077877-002ATENOLOLATENOLOL50MGTABLET / ORALAB2006-12-27
A077877-003ATENOLOLATENOLOL100MGTABLET / ORALAB2006-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077877-001AB
A077877-002AB
A077877-003AB

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 UTC2026-02A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077877-001ATENOLOL25MGTABLET / ORAL2006-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077877-002ATENOLOL50MGTABLET / ORAL2006-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077877-003ATENOLOL100MGTABLET / ORAL2006-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077877-001ATENOLOL25MGTABLET / ORAL2006-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077877-002ATENOLOL50MGTABLET / ORAL2006-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077877-003ATENOLOL100MGTABLET / ORAL2006-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077877-001ATENOLOL25MGTABLET / ORAL2006-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077877-002ATENOLOL50MGTABLET / ORAL2006-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077877-003ATENOLOL100MGTABLET / ORAL2006-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077877-001ATENOLOL25MGTABLET / ORAL2006-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077877-002ATENOLOL50MGTABLET / ORAL2006-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077877-003ATENOLOL100MGTABLET / ORAL2006-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077877-001ATENOLOL25MGTABLET / ORAL2006-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077877-002ATENOLOL50MGTABLET / ORAL2006-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077877-003ATENOLOL100MGTABLET / ORAL2006-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077877-002ATENOLOL50MGTABLET / ORALAB2006-12-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077877-003ATENOLOL100MGTABLET / ORALAB2006-12-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077877-001ATENOLOL25MGTABLET / ORALAB2006-12-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077877-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077877-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077877-003AB1011fe1cb6892…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077877-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077877-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077877-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077877-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077877-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077877-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077877-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077877-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077877-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077877-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077877-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077877-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077877-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077877-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077877-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077877-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077877-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077877-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077877-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077877-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077877-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077877-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077877-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077877-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077877-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077877-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077877-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077877-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077877-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077877-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077877-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077877-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077877-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077877-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077877-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077877-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077877-001AB1bb7c543d1eb4…

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
64725-0621-12019-11-27C16284748780-19855e2a2-38e8-60a7-e053-dbdaa90a05bdAtenolol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0621-1Atenolol100 in 1 BOTTLETABLET1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [TYA PHARMACEUTICALS]2
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [TYA PHARMACEUTICALS]2
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAATENOLOL TABLET [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JATENOLOL TABLET [TYA PHARMACEUTICALS]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJATENOLOL TABLET [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0621ATENOLOL TABLET [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140928_1998fa54-018e-45d2-826d-cc3eb570fd0b.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLIpca Laboratories Limited98d29958-b026-4888-a516-7bb85bb7d4792026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077877
application number: ANDA077877

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197380atenolol 25 MG Oral TabletPSN1998fa54-018e-45d2-826d-cc3eb570fd0b2
197380atenolol 25 MG Oral TabletSCD1998fa54-018e-45d2-826d-cc3eb570fd0b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0621-164725062101100 in 1 BOTTLEHistorical