FDA.reportPublic FDA data

Nebivolol

Product NDC
62559-278
11-digit product format
625590278
Labeler code
62559
Product ID
62559-278_4bca2b49-cd1c-4645-99e7-511dd1b67da6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA203659
Marketing category
ANDA
Marketing start
2021-09-17
Substance
NEBIVOLOL HYDROCHLORIDE
Active strength
20 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 HYDROCHLORIDE20 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
62559-278-05Nebivolol500 in 1 BOTTLETABLET5007
62559-278-30Nebivolol30 in 1 BOTTLETABLET307
62559-278-90Nebivolol90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-278-05EA - Each62559-2782a0b4b0b-5f11-41d6-9fc7-b338fa178d5c12021-12-08
62559-278-30EA - Each62559-278f84e19e7-0184-4e01-bc77-d7c1c3a4be2f12021-10-08
62559-278-90EA - Each62559-2785e6dfaef-3f9f-4f23-9007-8436b88b2bd012021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-278NEBIVOLOL TABLET [ANI PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 3 package rows20241215_3ebcc539-efe0-4545-bd83-37c20de7efb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSNc9d8edb5-5312-ad38-e053-2995a90a715410
751618nebivolol 2.5 MG Oral TabletPSNc9d8edb5-5312-ad38-e053-2995a90a715410
827073nebivolol 20 MG Oral TabletPSNc9d8edb5-5312-ad38-e053-2995a90a715410
387013nebivolol 5 MG Oral TabletPSNc9d8edb5-5312-ad38-e053-2995a90a715410
751612nebivolol 10 MG Oral TabletSCDc9d8edb5-5312-ad38-e053-2995a90a715410
751618nebivolol 2.5 MG Oral TabletSCDc9d8edb5-5312-ad38-e053-2995a90a715410
827073nebivolol 20 MG Oral TabletSCDc9d8edb5-5312-ad38-e053-2995a90a715410
387013nebivolol 5 MG Oral TabletSCDc9d8edb5-5312-ad38-e053-2995a90a715410
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSYc9d8edb5-5312-ad38-e053-2995a90a715410
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSYc9d8edb5-5312-ad38-e053-2995a90a715410
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSYc9d8edb5-5312-ad38-e053-2995a90a715410
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSYc9d8edb5-5312-ad38-e053-2995a90a715410
751612nebivolol 10 MG Oral TabletPSN3ebcc539-efe0-4545-bd83-37c20de7efb07
751618nebivolol 2.5 MG Oral TabletPSN3ebcc539-efe0-4545-bd83-37c20de7efb07
827073nebivolol 20 MG Oral TabletPSN3ebcc539-efe0-4545-bd83-37c20de7efb07
387013nebivolol 5 MG Oral TabletPSN3ebcc539-efe0-4545-bd83-37c20de7efb07
751612nebivolol 10 MG Oral TabletSCD3ebcc539-efe0-4545-bd83-37c20de7efb07
751618nebivolol 2.5 MG Oral TabletSCD3ebcc539-efe0-4545-bd83-37c20de7efb07
827073nebivolol 20 MG Oral TabletSCD3ebcc539-efe0-4545-bd83-37c20de7efb07
387013nebivolol 5 MG Oral TabletSCD3ebcc539-efe0-4545-bd83-37c20de7efb07
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY3ebcc539-efe0-4545-bd83-37c20de7efb07
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSY3ebcc539-efe0-4545-bd83-37c20de7efb07
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSY3ebcc539-efe0-4545-bd83-37c20de7efb07
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY3ebcc539-efe0-4545-bd83-37c20de7efb07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-278-0562559027805500 TABLET in 1 BOTTLE (62559-278-05) 500 tablet2021-11-150000-00-00NoNoCurrent
62559-278-306255902783030 TABLET in 1 BOTTLE (62559-278-30) 30 tablet2021-09-170000-00-00NoNoCurrent
62559-278-906255902789090 TABLET in 1 BOTTLE (62559-278-90) 90 tablet2021-09-170000-00-00NoNoCurrent