FDA.reportPublic FDA data

NEBIVOLOL

Product NDC
72205-153
11-digit product format
722050153
Labeler code
72205
Product ID
72205-153_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
20 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 HYDROCHLORIDE20 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
72205-153-30NEBIVOLOL30 in 1 BOTTLETABLET301
72205-153-90NEBIVOLOL90 in 1 BOTTLETABLET901
72205-153-91NEBIVOLOL100 in 1 BOTTLETABLET1001
72205-153-99NEBIVOLOL100 in 1 BOX, UNIT-DOSETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-153-30EA - Each72205-1532d72b614-0139-474f-bcb4-d714c668181612025-05-14
72205-153-90EA - Each72205-153fdf04bdc-0e4e-4f31-9352-2f130a688ea512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-153NEBIVOLOL 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 TabletPSN78c20341-4fbf-4c78-9817-03e7e0072f821
827073nebivolol 20 MG Oral TabletPSNe54ddb53-542b-4183-8950-5b3947ecead01
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 TabletSCD78c20341-4fbf-4c78-9817-03e7e0072f821
827073nebivolol 20 MG Oral TabletSCDe54ddb53-542b-4183-8950-5b3947ecead01
387013nebivolol 5 MG Oral TabletSCDe54ddb53-542b-4183-8950-5b3947ecead01
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 TabletSY78c20341-4fbf-4c78-9817-03e7e0072f821
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSYe54ddb53-542b-4183-8950-5b3947ecead01
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSYe54ddb53-542b-4183-8950-5b3947ecead01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-153-307220501533030 TABLET in 1 BOTTLE (72205-153-30) 30 tablet2024-11-22NoNoCurrent
72205-153-907220501539090 TABLET in 1 BOTTLE (72205-153-90) 90 tablet2024-11-22NoNoCurrent
72205-153-9172205015391100 TABLET in 1 BOTTLE (72205-153-91) 100 tablet2024-11-22NoNoCurrent
72205-153-9972205015399100 TABLET in 1 BOX, UNIT-DOSE (72205-153-99) 100 tablet2024-11-22NoNoCurrent