NEBIVOLOL

Product NDC
0904-7497
11-digit product format
009047497
Labeler code
0904
Product ID
0904-7497_2562c60f-8883-417d-a6db-01f4f243b199
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA212682
Marketing category
ANDA
Marketing start
2025-02-24
Substance
NEBIVOLOL
Active strength
2.5 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NEBIVOLOL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEBIVOLOL2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii030Y90569U
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
0904-7497-04NEBIVOLOL1 in 1 BLISTER PACKTABLET14
0904-7497-04NEBIVOLOL30 in 1 CARTONTABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7497-04EA - Each0904-749787a93dee-3150-4bfe-94ac-2cad65ece92812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7497NEBIVOLOL TABLET [MAJOR PHARMACEUTICALS]2Current NDC, 2 package rows20250410_3e9e1048-b5ea-4d6a-9363-3ee0d059e088.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSN3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
751618nebivolol 2.5 MG Oral TabletPSN3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
827073nebivolol 20 MG Oral TabletPSN3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
387013nebivolol 5 MG Oral TabletPSN3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
751612nebivolol 10 MG Oral TabletSCD3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
751618nebivolol 2.5 MG Oral TabletSCD3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
827073nebivolol 20 MG Oral TabletSCD3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
387013nebivolol 5 MG Oral TabletSCD3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSY3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSY3e9e1048-b5ea-4d6a-9363-3ee0d059e0884
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY3e9e1048-b5ea-4d6a-9363-3ee0d059e0884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7497-040090474970430 BLISTER PACK in 1 CARTON (0904-7497-04) / 1 TABLET in 1 BLISTER PACK30 blister pack2025-02-24NoNoHistorical