FDA.reportPublic FDA data

Nebivolol

Product NDC
72241-033
11-digit product format
722410033
Labeler code
72241
Product ID
72241-033_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
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEBIVOLOL HYDROCHLORIDE5 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
72241-033-04Nebivolol90 in 1 BOTTLETABLET904
72241-033-05Nebivolol100 in 1 BOTTLETABLET1004
72241-033-11Nebivolol1000 in 1 BOTTLETABLET10004
72241-033-22Nebivolol30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72241-033-04EA - Each72241-03373051fdd-a2f4-449d-bac9-1bdb866bd06512022-04-06
72241-033-22EA - Each72241-0332cc4e165-dc3e-4435-b01f-9cf6d9ec656412022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-033NEBIVOLOL 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
387013nebivolol 5 MG Oral TabletPSN9a5e1bd8-f2b6-42e6-972d-09418528cd63100
387013nebivolol 5 MG Oral TabletSCD9a5e1bd8-f2b6-42e6-972d-09418528cd63100
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY9a5e1bd8-f2b6-42e6-972d-09418528cd63100
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
72241-033-047224100330490 TABLET in 1 BOTTLE (72241-033-04) 90 tablet2021-12-180000-00-00NoNoCurrent
72241-033-0572241003305100 TABLET in 1 BOTTLE (72241-033-05) 100 tablet2021-12-180000-00-00NoNoCurrent
72241-033-11722410033111000 TABLET in 1 BOTTLE (72241-033-11) 1000 tablet2021-12-180000-00-00NoNoCurrent
72241-033-227224100332230 TABLET in 1 BOTTLE (72241-033-22) 30 tablet2021-12-180000-00-00NoNoCurrent