FDA.reportPublic FDA data

Nebivolol

Product NDC
50090-5708
11-digit product format
500905708
Labeler code
50090
Product ID
50090-5708_980722af-2bc3-492d-a8ff-835f3b69dd19
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
2.5 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nebivolol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEBIVOLOL HYDROCHLORIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJGS34J7L9I
Rxcui751618

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
50090-5708-02023-02-07C16284748780-1f386c649-aad2-0266-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
50090-5708-12023-02-07C16284748780-1f386c649-aad2-0266-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
50090-5708-02023-01-30C16284748780-1f386c649-aad2-0266-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
50090-5708-12023-01-30C16284748780-1f386c649-aad2-0266-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
50090-5708-0Nebivolol5 in 1 BOTTLETABLET55
50090-5708-1Nebivolol90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5708NEBIVOLOL TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20250221_5953f23b-2f41-4b49-bcdb-1691f4ffa35f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751618nebivolol 2.5 MG Oral TabletPSN5953f23b-2f41-4b49-bcdb-1691f4ffa35f5
751618nebivolol 2.5 MG Oral TabletSCD5953f23b-2f41-4b49-bcdb-1691f4ffa35f5
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSY5953f23b-2f41-4b49-bcdb-1691f4ffa35f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5708-0500905708005 TABLET in 1 BOTTLE (50090-5708-0) 5 tablet2021-09-230000-00-00NoNoCurrent
50090-5708-15009057080190 TABLET in 1 BOTTLE (50090-5708-1) 90 tablet2021-10-070000-00-00NoNoCurrent