Nebivolol

Product NDC
63629-4693
11-digit product format
636294693
Labeler code
63629
Product ID
63629-4693_31377ec0-88f3-4d00-8cfc-8a4c63750e7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203825
Marketing category
ANDA
Marketing start
2021-09-17
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4693-1Nebivolol30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4693NEBIVOLOL (NEBIVOLOL) TABLET [BRYANT RANCH PREPACK]1Current NDC, 1 package rows20241024_90d4ea48-7831-4cb0-8796-1ed79407c363.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387013nebivolol 5 MG Oral TabletPSN90d4ea48-7831-4cb0-8796-1ed79407c3631
387013nebivolol 5 MG Oral TabletSCD90d4ea48-7831-4cb0-8796-1ed79407c3631
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY90d4ea48-7831-4cb0-8796-1ed79407c3631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-4693-16362946930130 TABLET in 1 BOTTLE (63629-4693-1) 30 tablet2024-10-22NoNoCurrent