FDA.reportPublic FDA data

Nebivolol Hydrochloride

Product NDC
29300-378
11-digit product format
293000378
Labeler code
29300
Product ID
29300-378_1a80b28a-62f6-443e-8e8d-fc89b74be5ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nebivolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA213830
Marketing category
ANDA
Marketing start
2022-04-04
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 Hydrochloride
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
29300-378-05Nebivolol Hydrochloride500 in 1 BOTTLETABLET5004
29300-378-13Nebivolol Hydrochloride30 in 1 BOTTLETABLET304
29300-378-19Nebivolol Hydrochloride90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-378-13EA - Each29300-37868e7b743-17c4-44de-9fe7-ba59f0f24bbe12025-03-04
29300-378-19EA - Each29300-378c95b72cd-758e-456e-aec2-796be76af05712025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-378NEBIVOLOL HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]4Current NDC, Legacy NDC, 3 package rows20230718_b1762bbb-b5be-48a7-8101-bb736f28845a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751612nebivolol 10 MG Oral TabletPSNb1762bbb-b5be-48a7-8101-bb736f28845a4
751618nebivolol 2.5 MG Oral TabletPSNb1762bbb-b5be-48a7-8101-bb736f28845a4
827073nebivolol 20 MG Oral TabletPSNb1762bbb-b5be-48a7-8101-bb736f28845a4
387013nebivolol 5 MG Oral TabletPSNb1762bbb-b5be-48a7-8101-bb736f28845a4
751612nebivolol 10 MG Oral TabletSCDb1762bbb-b5be-48a7-8101-bb736f28845a4
751618nebivolol 2.5 MG Oral TabletSCDb1762bbb-b5be-48a7-8101-bb736f28845a4
827073nebivolol 20 MG Oral TabletSCDb1762bbb-b5be-48a7-8101-bb736f28845a4
387013nebivolol 5 MG Oral TabletSCDb1762bbb-b5be-48a7-8101-bb736f28845a4
751612nebivolol (as nebivolol hydrochloride) 10 MG Oral TabletSYb1762bbb-b5be-48a7-8101-bb736f28845a4
751618nebivolol (as nebivolol hydrochloride) 2.5 MG Oral TabletSYb1762bbb-b5be-48a7-8101-bb736f28845a4
827073nebivolol (as nebivolol hydrochloride) 20 MG Oral TabletSYb1762bbb-b5be-48a7-8101-bb736f28845a4
387013nebivolol (as nebivolol hydrochloride) 5 MG Oral TabletSYb1762bbb-b5be-48a7-8101-bb736f28845a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-378-0529300037805500 TABLET in 1 BOTTLE (29300-378-05) 500 tablet2022-04-040000-00-00NoNoCurrent
29300-378-132930003781330 TABLET in 1 BOTTLE (29300-378-13) 30 tablet2022-04-040000-00-00NoNoCurrent
29300-378-192930003781990 TABLET in 1 BOTTLE (29300-378-19) 90 tablet2022-04-040000-00-00NoNoCurrent