FDA.reportPublic FDA data

Carvedilol

Product NDC
71335-1407
11-digit product format
713351407
Labeler code
71335
Product ID
71335-1407_9ca14a4e-554a-4d13-af21-27ed797de50e
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
3.125 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carvedilol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL3.125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui686924

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
71335-1407-1Carvedilol30 in 1 BOTTLETablet, FILM COATED308
71335-1407-2Carvedilol100 in 1 BOTTLETablet, FILM COATED1008
71335-1407-3Carvedilol180 in 1 BOTTLETablet, FILM COATED1808
71335-1407-4Carvedilol60 in 1 BOTTLETablet, FILM COATED608
71335-1407-5Carvedilol90 in 1 BOTTLETablet, FILM COATED908
71335-1407-6Carvedilol120 in 1 BOTTLETablet, FILM COATED1208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1407CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 6 package rows20240725_cc3a9614-3017-4775-988e-6e5bd4621b70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686924carvedilol 3.125 MG Oral TabletPSNcc3a9614-3017-4775-988e-6e5bd4621b708
686924carvedilol 3.125 MG Oral TabletSCDcc3a9614-3017-4775-988e-6e5bd4621b708

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1407-17133514070130 TABLET, FILM COATED in 1 BOTTLE (71335-1407-1) 2020-12-080000-00-00NoNoCurrent
71335-1407-271335140702100 TABLET, FILM COATED in 1 BOTTLE (71335-1407-2) 2021-08-190000-00-00NoNoCurrent
71335-1407-371335140703180 TABLET, FILM COATED in 1 BOTTLE (71335-1407-3) 2020-09-110000-00-00NoNoCurrent
71335-1407-47133514070460 TABLET, FILM COATED in 1 BOTTLE (71335-1407-4) 2019-11-220000-00-00NoNoCurrent
71335-1407-57133514070590 TABLET, FILM COATED in 1 BOTTLE (71335-1407-5) 2019-11-270000-00-00NoNoCurrent
71335-1407-671335140706120 TABLET, FILM COATED in 1 BOTTLE (71335-1407-6) 2024-07-090000-00-00NoNoCurrent