FDA.reportPublic FDA data

NEBIVOLOL

Product NDC
43547-524
11-digit product format
435470524
Labeler code
43547
Product ID
43547-524_a3b47cb5-4f9f-4788-945b-0012a54c0884
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA212682
Marketing category
ANDA
Marketing start
2022-02-14
Substance
NEBIVOLOL
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEBIVOLOL2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii030Y90569U

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
43547-524-03NEBIVOLOL30 in 1 BOTTLETABLET303
43547-524-09NEBIVOLOL90 in 1 BOTTLETABLET903
43547-524-50NEBIVOLOL500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-524-03EA - Each43547-5247c1ee7c5-3dd2-48e1-ae66-2aaf99d948e112022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-524NEBIVOLOL TABLET [SOLCO HEALTHCARE US, LLC]3Current NDC, Legacy NDC, 3 package rows20250312_51d3f12f-94cc-4f58-94d3-61990e16adfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSN3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
751618nebivolol 2.5 MG Oral TabletPSN3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
827073nebivolol 20 MG Oral TabletPSN3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
387013nebivolol 5 MG Oral TabletPSN3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
751612nebivolol 10 MG Oral TabletSCD3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
751618nebivolol 2.5 MG Oral TabletSCD3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
827073nebivolol 20 MG Oral TabletSCD3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
387013nebivolol 5 MG Oral TabletSCD3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSY3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSY3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY3e9e1048-b5ea-4d6a-9363-3ee0d059e0884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-524-034354705240330 TABLET in 1 BOTTLE (43547-524-03) 30 tablet2022-02-140000-00-00NoNoCurrent
43547-524-094354705240990 TABLET in 1 BOTTLE (43547-524-09) 90 tablet2022-02-140000-00-00NoNoCurrent
43547-524-5043547052450500 TABLET in 1 BOTTLE (43547-524-50) 500 tablet2022-02-140000-00-00NoNoCurrent