NEBIVOLOL

Product NDC
70518-4032
11-digit product format
705184032
Labeler code
70518
Product ID
70518-4032_3f91fb6d-6d25-a881-e063-6394a90a3c61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212682
Marketing category
ANDA
Marketing start
2024-03-05
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
70518-4032-0NEBIVOLOL90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4032NEBIVOLOL TABLET [REMEDYREPACK INC.]1Current NDC, 1 package rows20240307_a9bad35e-cd48-48f1-93ca-46490dbf70a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387013nebivolol 5 MG Oral TabletPSNa9bad35e-cd48-48f1-93ca-46490dbf70a82
387013nebivolol 5 MG Oral TabletSCDa9bad35e-cd48-48f1-93ca-46490dbf70a82
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSYa9bad35e-cd48-48f1-93ca-46490dbf70a82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4032-07051840320090 TABLET in 1 BOTTLE, PLASTIC (70518-4032-0) 90 tablet2024-03-05NoNoHistorical