FDA.reportPublic FDA data

Nebivolol

Product NDC
71335-2646
11-digit product format
713352646
Labeler code
71335
Product ID
71335-2646_a2cbc9ff-9806-4cdb-9cd4-ec86026f9cf8
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
71335-2646-1Nebivolol90 in 1 BOTTLETABLET901
71335-2646-2Nebivolol30 in 1 BOTTLETABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387013nebivolol 5 MG Oral TabletPSN9f0bd0b4-ee17-46bb-b4e2-8ca0ea0e04891
387013nebivolol 5 MG Oral TabletSCD9f0bd0b4-ee17-46bb-b4e2-8ca0ea0e04891
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY9f0bd0b4-ee17-46bb-b4e2-8ca0ea0e04891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2646-17133526460190 TABLET in 1 BOTTLE (71335-2646-1) 90 tablet2025-06-03NoNoCurrent
71335-2646-27133526460230 TABLET in 1 BOTTLE (71335-2646-2) 30 tablet2025-06-03NoNoCurrent