FDA.reportPublic FDA data

Nebivolol

Product NDC
31722-585
11-digit product format
317220585
Labeler code
31722
Product ID
31722-585_103af555-44dd-5dfb-e063-6294a90a259f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA203825
Marketing category
ANDA
Marketing start
2021-09-17
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
31722-585-01Nebivolol100 in 1 BOTTLETABLET1002
31722-585-30Nebivolol30 in 1 BOTTLETABLET302
31722-585-31Nebivolol10 in 1 BLISTER PACKTABLET102
31722-585-32Nebivolol12 in 1 CARTONTABLET122
31722-585-33Nebivolol10 in 1 BLISTER PACKTABLET102
31722-585-34Nebivolol15 in 1 CARTONTABLET152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-585-30EA - Each31722-585c0b4d980-f12f-4925-bfa0-ef49cf48820112021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-585NEBIVOLOL (NEBIVOLOL) TABLET [CAMBER PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 6 package rows20240201_202d5142-6180-4d48-9a9f-1bd6992fc49b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSN202d5142-6180-4d48-9a9f-1bd6992fc49b2
751618nebivolol 2.5 MG Oral TabletPSN202d5142-6180-4d48-9a9f-1bd6992fc49b2
827073nebivolol 20 MG Oral TabletPSN202d5142-6180-4d48-9a9f-1bd6992fc49b2
387013nebivolol 5 MG Oral TabletPSN202d5142-6180-4d48-9a9f-1bd6992fc49b2
751612nebivolol 10 MG Oral TabletSCD202d5142-6180-4d48-9a9f-1bd6992fc49b2
751618nebivolol 2.5 MG Oral TabletSCD202d5142-6180-4d48-9a9f-1bd6992fc49b2
827073nebivolol 20 MG Oral TabletSCD202d5142-6180-4d48-9a9f-1bd6992fc49b2
387013nebivolol 5 MG Oral TabletSCD202d5142-6180-4d48-9a9f-1bd6992fc49b2
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY202d5142-6180-4d48-9a9f-1bd6992fc49b2
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSY202d5142-6180-4d48-9a9f-1bd6992fc49b2
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSY202d5142-6180-4d48-9a9f-1bd6992fc49b2
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY202d5142-6180-4d48-9a9f-1bd6992fc49b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-585-0131722058501100 TABLET in 1 BOTTLE (31722-585-01) 100 tablet2021-09-170000-00-00NoNoCurrent
31722-585-303172205853030 TABLET in 1 BOTTLE (31722-585-30) 30 tablet2021-09-170000-00-00NoNoCurrent
31722-585-313172205853110 in 1 BLISTER PACKHistorical
31722-585-323172205853212 BLISTER PACK in 1 CARTON (31722-585-32) / 10 TABLET in 1 BLISTER PACK (31722-585-31) 12 blister pack2021-09-170000-00-00NoNoCurrent
31722-585-333172205853310 in 1 BLISTER PACKHistorical
31722-585-343172205853415 BLISTER PACK in 1 CARTON (31722-585-34) / 10 TABLET in 1 BLISTER PACK (31722-585-33) 15 blister pack2021-09-170000-00-00NoNoCurrent