FDA.reportPublic FDA data

Nebivolol

Product NDC
63629-9424
11-digit product format
636299424
Labeler code
63629
Product ID
63629-9424_ebf0662a-eab8-48c6-8601-78198caec5b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211053
Marketing category
ANDA
Marketing start
2021-12-17
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
2026-12-31
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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJGS34J7L9I
Rxcui751612

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
63629-9424-1Nebivolol30 in 1 BOTTLETABLET30103
63629-9424-2Nebivolol90 in 1 BOTTLETABLET90103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9424NEBIVOLOL TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20250331_ef3b8ec9-0cec-40d4-824f-fc2b6cafd39a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSNef3b8ec9-0cec-40d4-824f-fc2b6cafd39a103
751612nebivolol 10 MG Oral TabletSCDef3b8ec9-0cec-40d4-824f-fc2b6cafd39a103
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSYef3b8ec9-0cec-40d4-824f-fc2b6cafd39a103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9424-16362994240130 TABLET in 1 BOTTLE (63629-9424-1) 30 tablet2022-08-160000-00-00NoNoCurrent
63629-9424-26362994240290 TABLET in 1 BOTTLE (63629-9424-2) 90 tablet2022-08-16NoNoHistorical