nebivolol

Product NDC
42291-873
11-digit product format
422910873
Labeler code
42291
Product ID
42291-873_48842030-a03d-fb38-e063-6294a90a9dd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nebivolol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA203821
Marketing category
ANDA
Marketing start
2024-07-10
Substance
NEBIVOLOL HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-873-90nebivolol90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-873-30EA - Each42291-873aef2deb9-b39f-4d6f-931d-e4382c48996012024-08-12
42291-873-90EA - Each42291-8736d67b591-b243-4459-8e4f-79d54479a9b312024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-873NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE) TABLET [AVKARE]1Current NDC, 1 package rows20240712_1ce89dc5-018d-db40-e063-6294a90a9722.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSN1ce89dc5-018d-db40-e063-6294a90a97222
751618nebivolol 2.5 MG Oral TabletPSN1ce89dc5-018d-db40-e063-6294a90a97222
827073nebivolol 20 MG Oral TabletPSN1ce89dc5-018d-db40-e063-6294a90a97222
387013nebivolol 5 MG Oral TabletPSN1ce89dc5-018d-db40-e063-6294a90a97222
751612nebivolol 10 MG Oral TabletSCD1ce89dc5-018d-db40-e063-6294a90a97222
751618nebivolol 2.5 MG Oral TabletSCD1ce89dc5-018d-db40-e063-6294a90a97222
827073nebivolol 20 MG Oral TabletSCD1ce89dc5-018d-db40-e063-6294a90a97222
387013nebivolol 5 MG Oral TabletSCD1ce89dc5-018d-db40-e063-6294a90a97222
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY1ce89dc5-018d-db40-e063-6294a90a97222
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSY1ce89dc5-018d-db40-e063-6294a90a97222
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSY1ce89dc5-018d-db40-e063-6294a90a97222
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY1ce89dc5-018d-db40-e063-6294a90a97222

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42291-873-904229108739090 TABLET in 1 BOTTLE (42291-873-90) 90 tablet2024-07-10NoNoCurrent