FDA.reportPublic FDA data

Nebivolol

Product NDC
50090-5752
11-digit product format
500905752
Labeler code
50090
Product ID
50090-5752_b7236465-ffd4-4834-8f62-227246ac4961
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203828
Marketing category
ANDA
Marketing start
2021-09-16
Substance
NEBIVOLOL HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nebivolol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEBIVOLOL HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJGS34J7L9I
Rxcui387013

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
50090-5752-02023-02-07C16284748780-1f386c649-ced6-0266-e053-dadaa90a7c1aThese 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
50090-5752-12023-02-07C16284748780-1f386c649-ced6-0266-e053-dadaa90a7c1aThese 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
50090-5752-02023-01-30C16284748780-1f386c649-ced6-0266-e053-dadaa90a7c1aThese 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
50090-5752-12023-01-30C16284748780-1f386c649-ced6-0266-e053-dadaa90a7c1aThese 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
50090-5752-0Nebivolol30 in 1 BOTTLETABLET308
50090-5752-1Nebivolol90 in 1 BOTTLETABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5752NEBIVOLOL TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20230524_f85d7b19-51d9-47d9-bd7b-13d45ad7759b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387013nebivolol 5 MG Oral TabletPSNf85d7b19-51d9-47d9-bd7b-13d45ad7759b8
387013nebivolol 5 MG Oral TabletSCDf85d7b19-51d9-47d9-bd7b-13d45ad7759b8
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSYf85d7b19-51d9-47d9-bd7b-13d45ad7759b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5752-05009057520030 TABLET in 1 BOTTLE (50090-5752-0) 30 tablet2021-09-300000-00-00NoNoCurrent
50090-5752-15009057520190 TABLET in 1 BOTTLE (50090-5752-1) 90 tablet2021-09-300000-00-00NoNoCurrent