FDA.reportPublic FDA data

Nadolol

Product NDC
76385-133
11-digit product format
763850133
Labeler code
76385
Product ID
76385-133_4cddb5b7-a38f-4360-9e37-f67386f05e55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nadolol
Dosage form
TABLET
Route
ORAL
Labeler
UNICHEM PHARMACEUTICALS (USA), INC.
Application
ANDA210955
Marketing category
ANDA
Marketing start
2019-07-26
Substance
NADOLOL
Active strength
20 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
Nadolol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NADOLOL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFEN504330V
Rxcui198006, 198007, 198008

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c3e14ce3-3dd7-c88b-aff9-2af221ac8a37Product name920240606
8fcb295c-5817-6981-e90d-9999d4e8f347Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76385-133-01Nadolol100 in 1 BOTTLETABLET1005
76385-133-10Nadolol1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76385-133-01EA - Each76385-133e884245f-c38a-4a00-b496-0864c1aacac012019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76385-133NADOLOL TABLET [BAYSHORE PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 2 package rows20240406_5a8014fb-9b65-4457-bfd5-0ab7e6de330e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198006nadolol 20 MG Oral TabletPSN5a8014fb-9b65-4457-bfd5-0ab7e6de330e5
198007nadolol 40 MG Oral TabletPSN5a8014fb-9b65-4457-bfd5-0ab7e6de330e5
198008nadolol 80 MG Oral TabletPSN5a8014fb-9b65-4457-bfd5-0ab7e6de330e5
198006nadolol 20 MG Oral TabletSCD5a8014fb-9b65-4457-bfd5-0ab7e6de330e5
198007nadolol 40 MG Oral TabletSCD5a8014fb-9b65-4457-bfd5-0ab7e6de330e5
198008nadolol 80 MG Oral TabletSCD5a8014fb-9b65-4457-bfd5-0ab7e6de330e5
198006nadolol 20 MG Oral TabletPSN33dcfdb9-1741-71e1-e063-6294a90afdff2
198007nadolol 40 MG Oral TabletPSN33dcfdb9-1741-71e1-e063-6294a90afdff2
198008nadolol 80 MG Oral TabletPSN33dcfdb9-1741-71e1-e063-6294a90afdff2
198006nadolol 20 MG Oral TabletSCD33dcfdb9-1741-71e1-e063-6294a90afdff2
198007nadolol 40 MG Oral TabletSCD33dcfdb9-1741-71e1-e063-6294a90afdff2
198008nadolol 80 MG Oral TabletSCD33dcfdb9-1741-71e1-e063-6294a90afdff2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76385-133-0176385013301100 TABLET in 1 BOTTLE (76385-133-01) 100 tablet2019-07-260000-00-00NoNoCurrent
76385-133-10763850133101000 TABLET in 1 BOTTLE (76385-133-10) 1000 tablet2019-07-260000-00-00NoNoCurrent