FDA.reportPublic FDA data

Nebivolol

Product NDC
72241-034
11-digit product format
722410034
Labeler code
72241
Product ID
72241-034_53d2f49b-b0b8-46fc-b80d-1ac3756e7e7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA208717
Marketing category
ANDA
Marketing start
2017-12-29
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
72241-034-04Nebivolol90 in 1 BOTTLETABLET904
72241-034-05Nebivolol100 in 1 BOTTLETABLET1004
72241-034-11Nebivolol1000 in 1 BOTTLETABLET10004
72241-034-22Nebivolol30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72241-034-04EA - Each72241-034bedfe6b4-b1d8-44b3-a357-0425e2f1088012022-04-06
72241-034-22EA - Each72241-034e3af88a0-b59e-4b19-b441-b68a9b987e2312022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-034NEBIVOLOL TABLET [MODAVAR PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 4 package rows20231110_19d20396-ade8-400e-94f4-69913637d051.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSN04a64dad-6922-4737-ab46-98c185782b38100
751612nebivolol 10 MG Oral TabletSCD04a64dad-6922-4737-ab46-98c185782b38100
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY04a64dad-6922-4737-ab46-98c185782b38100
751612nebivolol 10 MG Oral TabletPSN19d20396-ade8-400e-94f4-69913637d0514
751618nebivolol 2.5 MG Oral TabletPSN19d20396-ade8-400e-94f4-69913637d0514
827073nebivolol 20 MG Oral TabletPSN19d20396-ade8-400e-94f4-69913637d0514
387013nebivolol 5 MG Oral TabletPSN19d20396-ade8-400e-94f4-69913637d0514
751612nebivolol 10 MG Oral TabletSCD19d20396-ade8-400e-94f4-69913637d0514
751618nebivolol 2.5 MG Oral TabletSCD19d20396-ade8-400e-94f4-69913637d0514
827073nebivolol 20 MG Oral TabletSCD19d20396-ade8-400e-94f4-69913637d0514
387013nebivolol 5 MG Oral TabletSCD19d20396-ade8-400e-94f4-69913637d0514
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY19d20396-ade8-400e-94f4-69913637d0514
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSY19d20396-ade8-400e-94f4-69913637d0514
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSY19d20396-ade8-400e-94f4-69913637d0514
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY19d20396-ade8-400e-94f4-69913637d0514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72241-034-047224100340490 TABLET in 1 BOTTLE (72241-034-04) 90 tablet2021-12-180000-00-00NoNoCurrent
72241-034-0572241003405100 TABLET in 1 BOTTLE (72241-034-05) 100 tablet2021-12-180000-00-00NoNoCurrent
72241-034-11722410034111000 TABLET in 1 BOTTLE (72241-034-11) 1000 tablet2021-12-180000-00-00NoNoCurrent
72241-034-227224100342230 TABLET in 1 BOTTLE (72241-034-22) 30 tablet2021-12-180000-00-00NoNoCurrent