NEBIVOLOL

Product NDC
71335-2516
11-digit product format
713352516
Labeler code
71335
Product ID
71335-2516_afe4a662-64fe-49a5-a45c-2bee2070ef85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212682
Marketing category
ANDA
Marketing start
2022-02-14
Substance
NEBIVOLOL
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
NEBIVOLOL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii030Y90569U
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
71335-2516-1NEBIVOLOL30 in 1 BOTTLETABLET302
71335-2516-2NEBIVOLOL90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2516NEBIVOLOL TABLET [BRYANT RANCH PREPACK]2Current NDC, 2 package rows20250330_126de78c-fb3d-4a53-9aaf-f2dfe1ac2a2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387013nebivolol 5 MG Oral TabletPSN126de78c-fb3d-4a53-9aaf-f2dfe1ac2a2f2
387013nebivolol 5 MG Oral TabletSCD126de78c-fb3d-4a53-9aaf-f2dfe1ac2a2f2
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY126de78c-fb3d-4a53-9aaf-f2dfe1ac2a2f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2516-17133525160130 TABLET in 1 BOTTLE (71335-2516-1) 30 tablet2024-10-24NoNoCurrent
71335-2516-27133525160290 TABLET in 1 BOTTLE (71335-2516-2) 90 tablet2024-10-24NoNoCurrent