FDA.reportPublic FDA data

Nebivolol

Product NDC
59651-138
11-digit product format
596510138
Labeler code
59651
Product ID
59651-138_2690da17-6194-47ba-9078-e27821283ee2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA211053
Marketing category
ANDA
Marketing start
2021-12-17
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
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 HYDROCHLORIDE5 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
59651-138-30Nebivolol30 in 1 BOTTLETABLET304
59651-138-90Nebivolol90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-138-30EA - Each59651-1386921c5b8-2ba3-40b6-bd10-0452385575a412022-01-06
59651-138-90EA - Each59651-138f206c8a3-582e-4988-8bbc-b46a89709ee512022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-138NEBIVOLOL TABLET [AUROBINDO PHARMA LIMITED]3Current NDC, Legacy NDC, 2 package rows20250228_6e43a4e2-574e-4f4a-804d-e346b4edd2f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSN6e43a4e2-574e-4f4a-804d-e346b4edd2f14
751618nebivolol 2.5 MG Oral TabletPSN6e43a4e2-574e-4f4a-804d-e346b4edd2f14
827073nebivolol 20 MG Oral TabletPSN6e43a4e2-574e-4f4a-804d-e346b4edd2f14
387013nebivolol 5 MG Oral TabletPSN6e43a4e2-574e-4f4a-804d-e346b4edd2f14
751612nebivolol 10 MG Oral TabletSCD6e43a4e2-574e-4f4a-804d-e346b4edd2f14
751618nebivolol 2.5 MG Oral TabletSCD6e43a4e2-574e-4f4a-804d-e346b4edd2f14
827073nebivolol 20 MG Oral TabletSCD6e43a4e2-574e-4f4a-804d-e346b4edd2f14
387013nebivolol 5 MG Oral TabletSCD6e43a4e2-574e-4f4a-804d-e346b4edd2f14
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSY6e43a4e2-574e-4f4a-804d-e346b4edd2f14
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSY6e43a4e2-574e-4f4a-804d-e346b4edd2f14
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSY6e43a4e2-574e-4f4a-804d-e346b4edd2f14
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSY6e43a4e2-574e-4f4a-804d-e346b4edd2f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-138-305965101383030 TABLET in 1 BOTTLE (59651-138-30) 30 tablet2021-12-170000-00-00NoNoCurrent
59651-138-905965101389090 TABLET in 1 BOTTLE (59651-138-90) 90 tablet2021-12-170000-00-00NoNoCurrent