FDA.reportPublic FDA data

Nebivolol

Product NDC
60687-652
11-digit product format
606870652
Labeler code
60687
Product ID
60687-652_35420d8c-7a05-0220-e063-6394a90a1c25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203828
Marketing category
ANDA
Marketing start
2022-09-07
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

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
60687-652-11Nebivolol1 in 1 BLISTER PACKTABLET14
60687-652-21Nebivolol30 in 1 CARTONTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-652NEBIVOLOL TABLET [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 2 package rows20250519_5418f2b2-3e23-4e7a-b4df-36a1515c9a12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSN5418f2b2-3e23-4e7a-b4df-36a1515c9a124
387013nebivolol 5 MG Oral TabletPSN5418f2b2-3e23-4e7a-b4df-36a1515c9a124
751612nebivolol 10 MG Oral TabletSCD5418f2b2-3e23-4e7a-b4df-36a1515c9a124
387013nebivolol 5 MG Oral TabletSCD5418f2b2-3e23-4e7a-b4df-36a1515c9a124
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY5418f2b2-3e23-4e7a-b4df-36a1515c9a124
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY5418f2b2-3e23-4e7a-b4df-36a1515c9a124

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-652-11606870652111 in 1 BLISTER PACKHistorical
60687-652-216068706522130 BLISTER PACK in 1 CARTON (60687-652-21) / 1 TABLET in 1 BLISTER PACK (60687-652-11) 30 blister pack2022-09-070000-00-00NoNoCurrent