Atenolol

Product NDC
63187-092
11-digit product format
631870092
Labeler code
63187
Product ID
63187-092_d07f3951-beb5-4943-a972-0813a5ccda60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077877
Marketing category
ANDA
Marketing start
2007-12-04
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
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-092DDiscontinued by firm2026-08-03
excluded packagepackage63187-09263187-092-30DDiscontinued by firm2026-08-03
excluded packagepackage63187-09263187-092-90DDiscontinued by firm2026-08-03

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 · 6 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 packagepackage63187-092-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-092-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-092-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-092-90f5e01cc5f278…a2eaf40c39c3…

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 Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-092ATENOLOL TABLET [PROFICIENT RX LP]4Legacy NDC20191121_347befff-4a62-4205-bcf4-77c03f8aafa4.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-092-306318700923030 TABLET in 1 BOTTLE (63187-092-30) 30 tablet2018-11-010000-00-00NoNoCurrent
63187-092-906318700929090 TABLET in 1 BOTTLE (63187-092-90) 90 tablet2018-11-010000-00-00NoNoCurrent