FDA.reportPublic FDA data

Nebivolol

Product NDC
67877-391
11-digit product format
678770391
Labeler code
67877
Product ID
67877-391_4f315a54-2598-4463-8884-0b643e86f8c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA203828
Marketing category
ANDA
Marketing start
2021-09-16
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
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, 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
67877-391-01Nebivolol100 in 1 BOTTLETABLET10018
67877-391-30Nebivolol30 in 1 BOTTLETABLET3018
67877-391-33Nebivolol1 in 1 CARTONTABLET118
67877-391-33Nebivolol10 in 1 BLISTER PACKTABLET1018
67877-391-90Nebivolol90 in 1 BOTTLETABLET9018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-391NEBIVOLOL TABLET [ASCEND LABORATORIES, LLC]17Current NDC, Legacy NDC, 5 package rows20241122_fecef8fc-b66b-4133-b66f-8d6b72750622.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSNfecef8fc-b66b-4133-b66f-8d6b7275062218
751618nebivolol 2.5 MG Oral TabletPSNfecef8fc-b66b-4133-b66f-8d6b7275062218
827073nebivolol 20 MG Oral TabletPSNfecef8fc-b66b-4133-b66f-8d6b7275062218
387013nebivolol 5 MG Oral TabletPSNfecef8fc-b66b-4133-b66f-8d6b7275062218
751612nebivolol 10 MG Oral TabletSCDfecef8fc-b66b-4133-b66f-8d6b7275062218
751618nebivolol 2.5 MG Oral TabletSCDfecef8fc-b66b-4133-b66f-8d6b7275062218
827073nebivolol 20 MG Oral TabletSCDfecef8fc-b66b-4133-b66f-8d6b7275062218
387013nebivolol 5 MG Oral TabletSCDfecef8fc-b66b-4133-b66f-8d6b7275062218
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSYfecef8fc-b66b-4133-b66f-8d6b7275062218
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSYfecef8fc-b66b-4133-b66f-8d6b7275062218
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSYfecef8fc-b66b-4133-b66f-8d6b7275062218
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSYfecef8fc-b66b-4133-b66f-8d6b7275062218
751612nebivolol 10 MG Oral TabletPSNcdd7a3c5-d3dd-4a89-97d7-642f96eda21b5
751612nebivolol 10 MG Oral TabletSCDcdd7a3c5-d3dd-4a89-97d7-642f96eda21b5
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSYcdd7a3c5-d3dd-4a89-97d7-642f96eda21b5
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
67877-391-0167877039101100 TABLET in 1 BOTTLE (67877-391-01) 100 tablet2021-09-160000-00-00NoNoCurrent
67877-391-306787703913030 TABLET in 1 BOTTLE (67877-391-30) 30 tablet2021-09-160000-00-00NoNoCurrent
67877-391-33678770391331 BLISTER PACK in 1 CARTON (67877-391-33) / 10 TABLET in 1 BLISTER PACK1 blister pack2021-09-160000-00-00NoNoCurrent
67877-391-906787703919090 TABLET in 1 BOTTLE (67877-391-90) 90 tablet2021-09-160000-00-00NoNoCurrent