NEBIVOLOL

Product NDC
70518-4648
11-digit product format
705184648
Labeler code
70518
Product ID
70518-4648_509898af-5f31-b49c-e063-6394a90a4b82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NEBIVOLOL
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA217397
Marketing category
ANDA
Marketing start
2026-04-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NEBIVOLOL
Listing expiration
2027-12-31

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
70518-4648-0NEBIVOLOL50 in 1 BOXTABLET501
70518-4648-1NEBIVOLOL1 in 1 POUCHTABLET11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387013nebivolol 5 MG Oral TabletPSNafb38a32-1520-4fd9-ac00-cf6825dfe70a1
387013nebivolol 5 MG Oral TabletSCDafb38a32-1520-4fd9-ac00-cf6825dfe70a1
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSYafb38a32-1520-4fd9-ac00-cf6825dfe70a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4648-07051846480050 POUCH in 1 BOX (70518-4648-0) / 1 TABLET in 1 POUCH (70518-4648-1) 50 pouch2026-04-28NoNoCurrent
70518-4648-1705184648011 in 1 POUCHHistorical