NEBIVOLOL

Product NDC
71335-2443
11-digit product format
713352443
Labeler code
71335
Product ID
71335-2443_3e583d86-66cb-4a0f-a868-416721f24ad1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nebibolol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212682
Marketing category
ANDA
Marketing start
2022-02-14
Substance
NEBIVOLOL
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEBIVOLOL10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii030Y90569U
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
71335-2443-1NEBIVOLOL30 in 1 BOTTLETABLET301
71335-2443-2NEBIVOLOL90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2443NEBIVOLOL (NEBIBOLOL) TABLET [BRYANT RANCH PREPACK]1Current NDC, 2 package rows20240816_78c0945a-b8dc-4397-95d5-9f209224ad5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSN78c0945a-b8dc-4397-95d5-9f209224ad5e1
751612nebivolol 10 MG Oral TabletSCD78c0945a-b8dc-4397-95d5-9f209224ad5e1
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY78c0945a-b8dc-4397-95d5-9f209224ad5e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2443-17133524430130 TABLET in 1 BOTTLE (71335-2443-1) 30 tablet2024-08-15NoNoHistorical
71335-2443-27133524430290 TABLET in 1 BOTTLE (71335-2443-2) 90 tablet2024-08-15NoNoHistorical