FDA.reportPublic FDA data

Nebivolol

Product NDC
33342-457
11-digit product format
333420457
Labeler code
33342
Product ID
33342-457_b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA212661
Marketing category
ANDA
Marketing start
2025-01-29
Substance
NEBIVOLOL HYDROCHLORIDE
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEBIVOLOL HYDROCHLORIDE2.5 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
33342-457-07Nebivolol30 in 1 BOTTLETABLET301
33342-457-10Nebivolol90 in 1 BOTTLETABLET901
33342-457-25Nebivolol12 in 1 CARTONTABLET121
33342-457-25Nebivolol10 in 1 BLISTER PACKTABLET101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-457NEBIVOLOL TABLET [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 4 package rows20250528_b6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSNb6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e1
751618nebivolol 2.5 MG Oral TabletPSNb6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e1
827073nebivolol 20 MG Oral TabletPSNb6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e1
387013nebivolol 5 MG Oral TabletPSNb6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e1
751612nebivolol 10 MG Oral TabletSCDb6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e1
751618nebivolol 2.5 MG Oral TabletSCDb6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e1
827073nebivolol 20 MG Oral TabletSCDb6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e1
387013nebivolol 5 MG Oral TabletSCDb6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e1
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSYb6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e1
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSYb6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e1
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSYb6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e1
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSYb6c5abdd-bc2d-4ed6-8ca2-8a94c406ed0e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-457-073334204570730 TABLET in 1 BOTTLE (33342-457-07) 30 tablet2025-01-29NoNoCurrent
33342-457-103334204571090 TABLET in 1 BOTTLE (33342-457-10) 90 tablet2025-01-29NoNoCurrent
33342-457-253334204572512 BLISTER PACK in 1 CARTON (33342-457-25) / 10 TABLET in 1 BLISTER PACK12 blister pack2025-01-29NoNoCurrent