FDA.reportPublic FDA data

CARVEDILOL

Product NDC
71335-2033
11-digit product format
713352033
Labeler code
71335
Product ID
71335-2033_162141bd-9adf-40f3-9f63-d2ee2fef9476
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
6.25 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
2026-12-31
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
CARVEDILOL6.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200031

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
71335-2033-1CARVEDILOL30 in 1 BOTTLETABLET, FILM COATED30103
71335-2033-2CARVEDILOL60 in 1 BOTTLETABLET, FILM COATED60103
71335-2033-3CARVEDILOL100 in 1 BOTTLETABLET, FILM COATED100103
71335-2033-4CARVEDILOL180 in 1 BOTTLETABLET, FILM COATED180103
71335-2033-5CARVEDILOL90 in 1 BOTTLETABLET, FILM COATED90103
71335-2033-6CARVEDILOL120 in 1 BOTTLETABLET, FILM COATED120103
71335-2033-7CARVEDILOL25 in 1 BOTTLETABLET, FILM COATED25103
71335-2033-8CARVEDILOL10 in 1 BOTTLETABLET, FILM COATED10103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2033CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 8 package rows20240525_fe462198-32ae-4f6c-befc-acb97fb017c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSNfe462198-32ae-4f6c-befc-acb97fb017c9103
200031carvedilol 6.25 MG Oral TabletSCDfe462198-32ae-4f6c-befc-acb97fb017c9103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2033-17133520330130 TABLET, FILM COATED in 1 BOTTLE (71335-2033-1) 2022-02-100000-00-00NoNoCurrent
71335-2033-27133520330260 TABLET, FILM COATED in 1 BOTTLE (71335-2033-2) 2022-02-100000-00-00NoNoCurrent
71335-2033-371335203303100 TABLET, FILM COATED in 1 BOTTLE (71335-2033-3) 2022-02-100000-00-00NoNoCurrent
71335-2033-471335203304180 TABLET, FILM COATED in 1 BOTTLE (71335-2033-4) 2022-02-100000-00-00NoNoCurrent
71335-2033-57133520330590 TABLET, FILM COATED in 1 BOTTLE (71335-2033-5) 2022-02-100000-00-00NoNoCurrent
71335-2033-671335203306120 TABLET, FILM COATED in 1 BOTTLE (71335-2033-6) 2022-02-100000-00-00NoNoCurrent
71335-2033-77133520330725 TABLET, FILM COATED in 1 BOTTLE (71335-2033-7) 2022-02-100000-00-00NoNoCurrent
71335-2033-87133520330810 TABLET, FILM COATED in 1 BOTTLE (71335-2033-8) 2022-02-100000-00-00NoNoCurrent