FDA.reportPublic FDA data

Nebivolol

Product NDC
27241-181
11-digit product format
272410181
Labeler code
27241
Product ID
27241-181_4c94e072-38a5-49ca-98ac-90a6319f614d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA213349
Marketing category
ANDA
Marketing start
2022-03-31
Marketing end
0000-00-00
Substance
NEBIVOLOL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b9af42fa-00cc-b314-02ce-e06da0a12313Product name620250423
52311e76-a520-4bd2-9d5b-e0b6d6f44519Product name220231208

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
27241-181-302026-01-29C16284748780-149896155-bdd7-586f-e063-e6dba90add90These highlights do not include all the information needed to use NEBIVOLOL TABLETS safely and effectively. See full prescribing information for NEBIVOLOL TABLETS. NEBIVOLOL tablets, for oral use Initial U.S. Approval: 2007
27241-181-902026-01-29C16284748780-149896155-bdd7-586f-e063-e6dba90add90These highlights do not include all the information needed to use NEBIVOLOL TABLETS safely and effectively. See full prescribing information for NEBIVOLOL TABLETS. NEBIVOLOL tablets, for oral use Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-181-30Nebivolol30 in 1 BOTTLETABLET304
27241-181-90Nebivolol90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-181NEBIVOLOL TABLET [AJANTA PHARMA USA INC.]4Legacy NDC, 2 package rows20230907_375f239f-58a7-496b-b0ce-dbacf4b82757.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSN375f239f-58a7-496b-b0ce-dbacf4b827574
751618nebivolol 2.5 MG Oral TabletPSN375f239f-58a7-496b-b0ce-dbacf4b827574
827073nebivolol 20 MG Oral TabletPSN375f239f-58a7-496b-b0ce-dbacf4b827574
387013nebivolol 5 MG Oral TabletPSN375f239f-58a7-496b-b0ce-dbacf4b827574
751612nebivolol 10 MG Oral TabletSCD375f239f-58a7-496b-b0ce-dbacf4b827574
751618nebivolol 2.5 MG Oral TabletSCD375f239f-58a7-496b-b0ce-dbacf4b827574
827073nebivolol 20 MG Oral TabletSCD375f239f-58a7-496b-b0ce-dbacf4b827574
387013nebivolol 5 MG Oral TabletSCD375f239f-58a7-496b-b0ce-dbacf4b827574
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY375f239f-58a7-496b-b0ce-dbacf4b827574
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSY375f239f-58a7-496b-b0ce-dbacf4b827574
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSY375f239f-58a7-496b-b0ce-dbacf4b827574
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY375f239f-58a7-496b-b0ce-dbacf4b827574

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-181-302724101813030 TABLET in 1 BOTTLE (27241-181-30) 30 tablet2022-03-310000-00-00NoNoCurrent
27241-181-902724101819090 TABLET in 1 BOTTLE (27241-181-90) 90 tablet2022-03-310000-00-00NoNoCurrent