FDA.reportPublic FDA data

Nebivolol

Product NDC
62559-275
11-digit product format
625590275
Labeler code
62559
Product ID
62559-275_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
2.5 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
NEBIVOLOL HYDROCHLORIDE2.5 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
62559-275-30Nebivolol30 in 1 BOTTLETABLET307
62559-275-83Nebivolol2300 in 1 BOTTLETABLET23007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-275-30EA - Each62559-275a0b44149-37da-4c0c-a050-d46492e6b71b12021-10-08
62559-275-83EA - Each62559-2750afc54c3-f957-4067-908d-18339ad0cf1212021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-275NEBIVOLOL TABLET [ANI PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 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
62559-275-306255902753030 TABLET in 1 BOTTLE (62559-275-30) 30 tablet2021-09-170000-00-00NoNoCurrent
62559-275-83625590275832300 TABLET in 1 BOTTLE (62559-275-83) 2300 tablet2021-09-170000-00-00NoNoCurrent