Nebivolol

Product NDC
82804-120
11-digit product format
828040120
Labeler code
82804
Product ID
82804-120_c6606db5-3937-4e90-9870-3cbfa4ec909e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203825
Marketing category
ANDA
Marketing start
2021-09-17
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

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
82804-120-90Nebivolol90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-120-90EA - Each82804-12072d51f5b-69d5-459c-b0b9-95d8d817f3a112024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-120NEBIVOLOL TABLET [PROFICIENT RX LP]1Current NDC, 1 package rows20240711_c6606db5-3937-4e90-9870-3cbfa4ec909e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
387013nebivolol 5 MG Oral TabletPSNc6606db5-3937-4e90-9870-3cbfa4ec909e1
387013nebivolol 5 MG Oral TabletSCDc6606db5-3937-4e90-9870-3cbfa4ec909e1
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSYc6606db5-3937-4e90-9870-3cbfa4ec909e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-120-908280401209090 TABLET in 1 BOTTLE (82804-120-90) 90 tablet2024-07-08NoNoCurrent