FDA.reportPublic FDA data

Nebivolol

Product NDC
51407-485
11-digit product format
514070485
Labeler code
51407
Product ID
51407-485_48392f96-85ae-e631-e063-6294a90a2568
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA203659
Marketing category
ANDA
Marketing start
2015-04-16
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
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 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
51407-485-30Nebivolol30 in 1 BOTTLETABLET3010
51407-485-90Nebivolol90 in 1 BOTTLETABLET9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-485-30EA - Each51407-4857b4e40bf-1f90-4d7c-8fd1-1733d56645ba12021-10-08
51407-485-90EA - Each51407-4851e7966bb-21dd-4798-a4c5-ce77e613d80812021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-485NEBIVOLOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]9Current NDC, Legacy NDC, 2 package rows20241228_c9d8edb5-5312-ad38-e053-2995a90a7154.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-485-305140704853030 TABLET in 1 BOTTLE (51407-485-30) 30 tablet2021-09-170000-00-00NoNoCurrent
51407-485-905140704859090 TABLET in 1 BOTTLE (51407-485-90) 90 tablet2021-09-170000-00-00NoNoCurrent