FDA.reportPublic FDA data

NEBIVOLOL

Product NDC
71335-3102
11-digit product format
713353102
Labeler code
71335
Product ID
71335-3102_5e2d131f-0cd1-4940-a82b-ab59a1bf21da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NEBIVOLOL
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217397
Marketing category
ANDA
Marketing start
2024-10-01
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
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 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
71335-3102-1NEBIVOLOL30 in 1 BOTTLETABLET301
71335-3102-2NEBIVOLOL90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSNaad20a92-bc2e-4624-b588-c6d40facd3a71
751612nebivolol 10 MG Oral TabletSCDaad20a92-bc2e-4624-b588-c6d40facd3a71
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSYaad20a92-bc2e-4624-b588-c6d40facd3a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3102-17133531020130 TABLET in 1 BOTTLE (71335-3102-1) 30 tablet2026-03-16NoNoHistorical
71335-3102-27133531020290 TABLET in 1 BOTTLE (71335-3102-2) 90 tablet2026-03-16NoNoHistorical