NEBIVOLOL

Product NDC
72205-151
11-digit product format
722050151
Labeler code
72205
Product ID
72205-151_e54ddb53-542b-4183-8950-5b3947ecead0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NEBIVOLOL
Dosage form
TABLET
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA217397
Marketing category
ANDA
Marketing start
2024-10-01
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
72205-151-30NEBIVOLOL30 in 1 BOTTLETABLET301
72205-151-90NEBIVOLOL90 in 1 BOTTLETABLET901
72205-151-91NEBIVOLOL100 in 1 BOTTLETABLET1001
72205-151-99NEBIVOLOL100 in 1 BOX, UNIT-DOSETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-151-30EA - Each72205-151afea6cd5-c03a-4dcb-99b0-ebcee14973f312025-05-14
72205-151-90EA - Each72205-151de255ce9-0b41-4bd1-84f6-1ff04ad2dfea12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-151NEBIVOLOL TABLET [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 4 package rows20241201_e54ddb53-542b-4183-8950-5b3947ecead0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSNe54ddb53-542b-4183-8950-5b3947ecead01
751618nebivolol 2.5 MG Oral TabletPSNe54ddb53-542b-4183-8950-5b3947ecead01
827073nebivolol 20 MG Oral TabletPSNe54ddb53-542b-4183-8950-5b3947ecead01
387013nebivolol 5 MG Oral TabletPSN156c41be-551b-46ab-86a8-52f6f70a46891
387013nebivolol 5 MG Oral TabletPSNafb38a32-1520-4fd9-ac00-cf6825dfe70a1
387013nebivolol 5 MG Oral TabletPSNe54ddb53-542b-4183-8950-5b3947ecead01
751612nebivolol 10 MG Oral TabletSCDe54ddb53-542b-4183-8950-5b3947ecead01
751618nebivolol 2.5 MG Oral TabletSCDe54ddb53-542b-4183-8950-5b3947ecead01
827073nebivolol 20 MG Oral TabletSCDe54ddb53-542b-4183-8950-5b3947ecead01
387013nebivolol 5 MG Oral TabletSCDe54ddb53-542b-4183-8950-5b3947ecead01
387013nebivolol 5 MG Oral TabletSCDafb38a32-1520-4fd9-ac00-cf6825dfe70a1
387013nebivolol 5 MG Oral TabletSCD156c41be-551b-46ab-86a8-52f6f70a46891
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSYe54ddb53-542b-4183-8950-5b3947ecead01
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSYe54ddb53-542b-4183-8950-5b3947ecead01
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSYe54ddb53-542b-4183-8950-5b3947ecead01
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSYafb38a32-1520-4fd9-ac00-cf6825dfe70a1
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSYe54ddb53-542b-4183-8950-5b3947ecead01
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY156c41be-551b-46ab-86a8-52f6f70a46891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-151-307220501513030 TABLET in 1 BOTTLE (72205-151-30) 30 tablet2024-11-22NoNoCurrent
72205-151-907220501519090 TABLET in 1 BOTTLE (72205-151-90) 90 tablet2024-11-22NoNoCurrent
72205-151-9172205015191100 TABLET in 1 BOTTLE (72205-151-91) 100 tablet2024-11-22NoNoCurrent
72205-151-9972205015199100 TABLET in 1 BOX, UNIT-DOSE (72205-151-99) 100 tablet2024-11-22NoNoCurrent