FDA.reportPublic FDA data

CARVEDILOL

Product NDC
71335-2023
11-digit product format
713352023
Labeler code
71335
Product ID
71335-2023_6f8dec1e-7fea-454b-99c7-4e3543647336
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARVEDILOL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078165
Marketing category
ANDA
Marketing start
2021-07-29
Substance
CARVEDILOL
Active strength
25 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
CARVEDILOL25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200033

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
71335-2023-1CARVEDILOL100 in 1 BOTTLETABLET, FILM COATED100103
71335-2023-2CARVEDILOL30 in 1 BOTTLETABLET, FILM COATED30103
71335-2023-3CARVEDILOL90 in 1 BOTTLETABLET, FILM COATED90103
71335-2023-4CARVEDILOL60 in 1 BOTTLETABLET, FILM COATED60103
71335-2023-5CARVEDILOL120 in 1 BOTTLETABLET, FILM COATED120103
71335-2023-6CARVEDILOL180 in 1 BOTTLETABLET, FILM COATED180103
71335-2023-7CARVEDILOL10 in 1 BOTTLETABLET, FILM COATED10103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2023CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 7 package rows20231109_1ddff189-1848-4186-bca9-063e4ea7fd1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200033carvedilol 25 MG Oral TabletPSN1ddff189-1848-4186-bca9-063e4ea7fd1f103
200033carvedilol 25 MG Oral TabletSCD1ddff189-1848-4186-bca9-063e4ea7fd1f103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2023-171335202301100 TABLET, FILM COATED in 1 BOTTLE (71335-2023-1) 2022-02-100000-00-00NoNoCurrent
71335-2023-27133520230230 TABLET, FILM COATED in 1 BOTTLE (71335-2023-2) 2022-02-100000-00-00NoNoCurrent
71335-2023-37133520230390 TABLET, FILM COATED in 1 BOTTLE (71335-2023-3) 2022-02-100000-00-00NoNoCurrent
71335-2023-47133520230460 TABLET, FILM COATED in 1 BOTTLE (71335-2023-4) 2022-02-100000-00-00NoNoCurrent
71335-2023-571335202305120 TABLET, FILM COATED in 1 BOTTLE (71335-2023-5) 2022-02-100000-00-00NoNoCurrent
71335-2023-671335202306180 TABLET, FILM COATED in 1 BOTTLE (71335-2023-6) 2022-02-100000-00-00NoNoCurrent
71335-2023-77133520230710 TABLET, FILM COATED in 1 BOTTLE (71335-2023-7) 2022-02-100000-00-00NoNoCurrent