FDA.reportPublic FDA data

Nebivolol

Product NDC
70756-293
11-digit product format
707560293
Labeler code
70756
Product ID
70756-293_2ffb359c-7e4b-44ef-a0c7-451ac966f6b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA216172
Marketing category
ANDA
Marketing start
2022-11-14
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
70756-293-30Nebivolol30 in 1 BOTTLETABLET305
70756-293-90Nebivolol90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-293-30EA - Each70756-293a14a204c-2a99-44df-a830-7304d9f8398012023-05-05
70756-293-90EA - Each70756-2939b067cf5-b84b-4dd4-a1d7-a133762d482712023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-293NEBIVOLOL TABLET [LIFESTAR PHARMA LLC]5Current NDC, Legacy NDC, 2 package rows20230717_2639abce-a5ca-4b7f-99d7-026ab3233aaa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSN2639abce-a5ca-4b7f-99d7-026ab3233aaa5
751618nebivolol 2.5 MG Oral TabletPSN2639abce-a5ca-4b7f-99d7-026ab3233aaa5
827073nebivolol 20 MG Oral TabletPSN2639abce-a5ca-4b7f-99d7-026ab3233aaa5
387013nebivolol 5 MG Oral TabletPSN2639abce-a5ca-4b7f-99d7-026ab3233aaa5
751612nebivolol 10 MG Oral TabletSCD2639abce-a5ca-4b7f-99d7-026ab3233aaa5
751618nebivolol 2.5 MG Oral TabletSCD2639abce-a5ca-4b7f-99d7-026ab3233aaa5
827073nebivolol 20 MG Oral TabletSCD2639abce-a5ca-4b7f-99d7-026ab3233aaa5
387013nebivolol 5 MG Oral TabletSCD2639abce-a5ca-4b7f-99d7-026ab3233aaa5
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY2639abce-a5ca-4b7f-99d7-026ab3233aaa5
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSY2639abce-a5ca-4b7f-99d7-026ab3233aaa5
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSY2639abce-a5ca-4b7f-99d7-026ab3233aaa5
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY2639abce-a5ca-4b7f-99d7-026ab3233aaa5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70756-293-307075602933030 TABLET in 1 BOTTLE (70756-293-30) 30 tablet2022-11-140000-00-00NoNoCurrent
70756-293-907075602939090 TABLET in 1 BOTTLE (70756-293-90) 90 tablet2022-11-140000-00-00NoNoCurrent