ATENOLOL

Product NDC
61919-581
11-digit product format
619190581
Labeler code
61919
Product ID
61919-581_9c5970fb-9b71-6e87-e053-2a95a90a6889
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATENOLOL
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA076900
Marketing category
ANDA
Marketing start
2017-07-19
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
2021-12-31
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 productproduct61919-581IInactivated by FDA2026-08-03
excluded packagepackage61919-58161919-581-60IInactivated 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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-581-60IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-581-60IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-581-60IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-581-60IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-581-60IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-581-60IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-581-60IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-581-60IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-581-60IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-581-60IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-581-60IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-581-60IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-581-60IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-581-60IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-581-60IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61919-581-60EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
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
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
5eb1a708-d713-e905-0a08-b103c64796f4Product name320201019

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-581-602023-01-30C16284748780-1f386c649-ef2f-0266-e053-dadaa90a7c1aATENOLOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-581-60ATENOLOL60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-581-60EA - Each61919-58143295a75-bb78-4413-aa97-521c750f820012017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-581ATENOLOL TABLET [DIRECT RX]2Legacy NDC, 1 package rows20200118_54b0cbf0-388b-6928-e054-00144ff8d46c.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
197380atenolol 25 MG Oral TabletPSN54b0cbf0-388b-6928-e054-00144ff8d46c2
197380atenolol 25 MG Oral TabletSCD54b0cbf0-388b-6928-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-581-606191905816060 TABLET in 1 BOTTLE (61919-581-60) 60 tablet2017-07-190000-00-00NoNoCurrent