Atenolol

Product NDC
63187-201
11-digit product format
631870201
Labeler code
63187
Product ID
63187-201_93d667f2-a0fd-4def-85ad-f89ae36b78e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA073025
Marketing category
ANDA
Marketing start
1991-09-17
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
2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-201DDiscontinued by firm2026-08-03
excluded packagepackage63187-20163187-201-30DDiscontinued by firm2026-08-03
excluded packagepackage63187-20163187-201-60DDiscontinued by firm2026-08-03
excluded packagepackage63187-20163187-201-90DDiscontinued 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 · 8 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 packagepackage63187-201-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-201-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-201-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-201-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-201-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-201-90f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A073025-001ATENOLOL50MGTABLET / ORALAB1991-09-1774a2ff9319b5…
2019-12-14 00:12 UTC2019-12A073025-001ATENOLOL50MGTABLET / ORALAB1991-09-173f01610625f2…
2019-09-15 20:21 UTC2019-09A073025-001ATENOLOL50MGTABLET / ORALAB1991-09-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A073025-001ATENOLOL50MGTABLET / ORALAB1991-09-17ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A073025-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A073025-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A073025-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A073025-001AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-201-30EA - Each63187-20103390c3f-f01b-4e3c-a28f-2aeaec9cb93312017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [PROFICIENT RX LP]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-201ATENOLOL TABLET [PROFICIENT RX LP]4Legacy NDC20210121_06c0a04f-a77e-4871-9bb4-13abe2cbbe7a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-201-306318702013030 TABLET in 1 BOTTLE (63187-201-30) 30 tablet2015-02-020000-00-00NoNoCurrent
63187-201-606318702016060 TABLET in 1 BOTTLE (63187-201-60) 60 tablet2015-02-020000-00-00NoNoCurrent
63187-201-906318702019090 TABLET in 1 BOTTLE (63187-201-90) 90 tablet2015-02-020000-00-00NoNoCurrent