NEBIVOLOL

Product NDC
50090-7853
11-digit product format
500907853
Labeler code
50090
Product ID
50090-7853_caccc638-504d-4309-a952-dda8de1f85c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NEBIVOLOL
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
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
NEBIVOLOL HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJGS34J7L9I
Rxcui827073

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
50090-7853-1NEBIVOLOL30 in 1 BOTTLETABLET301
50090-7853-2NEBIVOLOL90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7853-1EA - Each50090-7853e30eda7c-a519-4ec1-af2e-8e470d392f6612026-02-05
50090-7853-2EA - Each50090-7853e0dc0cda-66c9-4a63-ab85-636af822644c12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
827073nebivolol 20 MG Oral TabletPSN78c20341-4fbf-4c78-9817-03e7e0072f821
827073nebivolol 20 MG Oral TabletSCD78c20341-4fbf-4c78-9817-03e7e0072f821
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSY78c20341-4fbf-4c78-9817-03e7e0072f821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7853-15009078530130 TABLET in 1 BOTTLE (50090-7853-1) 30 tablet2026-01-08NoNoHistorical
50090-7853-25009078530290 TABLET in 1 BOTTLE (50090-7853-2) 90 tablet2026-01-08NoNoHistorical