FDA.reportPublic FDA data

Carvedilol

Product NDC
71335-1813
11-digit product format
713351813
Labeler code
71335
Product ID
71335-1813_20c68c68-b8ef-437c-8baa-878fcb2e0993
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078384
Marketing category
ANDA
Marketing start
2016-10-01
Substance
CARVEDILOL
Active strength
12.5 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], 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
Carvedilol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200032

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1813-1Carvedilol30 in 1 BOTTLE, PLASTICTablet, FILM COATED30105
71335-1813-2Carvedilol60 in 1 BOTTLE, PLASTICTablet, FILM COATED60105
71335-1813-3Carvedilol100 in 1 BOTTLE, PLASTICTablet, FILM COATED100105
71335-1813-4Carvedilol90 in 1 BOTTLE, PLASTICTablet, FILM COATED90105
71335-1813-5Carvedilol120 in 1 BOTTLE, PLASTICTablet, FILM COATED120105
71335-1813-6Carvedilol180 in 1 BOTTLE, PLASTICTablet, FILM COATED180105
71335-1813-7Carvedilol10 in 1 BOTTLE, PLASTICTablet, FILM COATED10105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1813CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 7 package rows20240726_21191d89-16f6-49a8-9394-f31d0950deea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN21191d89-16f6-49a8-9394-f31d0950deea105
200032carvedilol 12.5 MG Oral TabletSCD21191d89-16f6-49a8-9394-f31d0950deea105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1813-17133518130130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1813-1) 2024-07-170000-00-00NoNoCurrent
71335-1813-27133518130260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1813-2) 2021-06-110000-00-00NoNoCurrent
71335-1813-371335181303100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1813-3) 2023-09-060000-00-00NoNoCurrent
71335-1813-47133518130490 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1813-4) 2021-08-100000-00-00NoNoCurrent
71335-1813-571335181305120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1813-5) 2024-07-170000-00-00NoNoCurrent
71335-1813-671335181306180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1813-6) 2021-10-270000-00-00NoNoCurrent
71335-1813-77133518130710 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1813-7) 2024-07-170000-00-00NoNoCurrent