FDA.reportPublic FDA data

nebivolol

Product NDC
24689-161
11-digit product format
246890161
Labeler code
24689
Product ID
24689-161_ffc06b5e-4f7d-4020-8be9-a4e903c1bfa8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nebivolol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Apnar Pharma LP
Application
ANDA216568
Marketing category
ANDA
Marketing start
2024-05-13
Substance
NEBIVOLOL HYDROCHLORIDE
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
NEBIVOLOL HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJGS34J7L9I
Rxcui387013, 751612, 751618, 827073

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
24689-161-01nebivolol30 in 1 BOTTLETABLET304
24689-161-02nebivolol90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24689-161NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE) TABLET [APNAR PHARMA LP]4Current NDC, 2 package rows20250226_3f5766c0-e1fa-4805-a32c-523182310ad5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSN3f5766c0-e1fa-4805-a32c-523182310ad54
751618nebivolol 2.5 MG Oral TabletPSN3f5766c0-e1fa-4805-a32c-523182310ad54
827073nebivolol 20 MG Oral TabletPSN3f5766c0-e1fa-4805-a32c-523182310ad54
387013nebivolol 5 MG Oral TabletPSN3f5766c0-e1fa-4805-a32c-523182310ad54
751612nebivolol 10 MG Oral TabletSCD3f5766c0-e1fa-4805-a32c-523182310ad54
751618nebivolol 2.5 MG Oral TabletSCD3f5766c0-e1fa-4805-a32c-523182310ad54
827073nebivolol 20 MG Oral TabletSCD3f5766c0-e1fa-4805-a32c-523182310ad54
387013nebivolol 5 MG Oral TabletSCD3f5766c0-e1fa-4805-a32c-523182310ad54
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY3f5766c0-e1fa-4805-a32c-523182310ad54
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSY3f5766c0-e1fa-4805-a32c-523182310ad54
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSY3f5766c0-e1fa-4805-a32c-523182310ad54
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY3f5766c0-e1fa-4805-a32c-523182310ad54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24689-161-012468901610130 TABLET in 1 BOTTLE (24689-161-01) 30 tablet2024-05-13NoNoCurrent
24689-161-022468901610290 TABLET in 1 BOTTLE (24689-161-02) 90 tablet2024-05-13NoNoCurrent