FDA.reportPublic FDA data

NEBIVOLOL

Product NDC
71335-2648
11-digit product format
713352648
Labeler code
71335
Product ID
71335-2648_366e45a3-20d8-4707-ba64-d12985872b58
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
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
71335-2648-1NEBIVOLOL30 in 1 BOTTLETABLET301
71335-2648-2NEBIVOLOL90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387013nebivolol 5 MG Oral TabletPSN156c41be-551b-46ab-86a8-52f6f70a46891
387013nebivolol 5 MG Oral TabletSCD156c41be-551b-46ab-86a8-52f6f70a46891
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY156c41be-551b-46ab-86a8-52f6f70a46891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2648-17133526480130 TABLET in 1 BOTTLE (71335-2648-1) 30 tablet2025-06-03NoNoHistorical
71335-2648-27133526480290 TABLET in 1 BOTTLE (71335-2648-2) 90 tablet2025-06-03NoNoHistorical