FDA.reportPublic FDA data

CARVEDILOL

Product NDC
71335-2026
11-digit product format
713352026
Labeler code
71335
Product ID
71335-2026_419c99fb-aecb-4336-a464-452b01a75896
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
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
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
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
71335-2026-1CARVEDILOL30 in 1 BOTTLETABLET, FILM COATED30102
71335-2026-2CARVEDILOL60 in 1 BOTTLETABLET, FILM COATED60102
71335-2026-3CARVEDILOL100 in 1 BOTTLETABLET, FILM COATED100102
71335-2026-4CARVEDILOL90 in 1 BOTTLETABLET, FILM COATED90102
71335-2026-5CARVEDILOL120 in 1 BOTTLETABLET, FILM COATED120102
71335-2026-6CARVEDILOL180 in 1 BOTTLETABLET, FILM COATED180102
71335-2026-7CARVEDILOL10 in 1 BOTTLETABLET, FILM COATED10102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2026CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 7 package rows20231102_03b7c07c-14ba-40c8-8c0a-8dfa4a10f580.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN03b7c07c-14ba-40c8-8c0a-8dfa4a10f580102
200032carvedilol 12.5 MG Oral TabletSCD03b7c07c-14ba-40c8-8c0a-8dfa4a10f580102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2026-17133520260130 TABLET, FILM COATED in 1 BOTTLE (71335-2026-1) 2022-02-100000-00-00NoNoCurrent
71335-2026-27133520260260 TABLET, FILM COATED in 1 BOTTLE (71335-2026-2) 2022-02-100000-00-00NoNoCurrent
71335-2026-371335202603100 TABLET, FILM COATED in 1 BOTTLE (71335-2026-3) 2022-02-100000-00-00NoNoCurrent
71335-2026-47133520260490 TABLET, FILM COATED in 1 BOTTLE (71335-2026-4) 2022-02-100000-00-00NoNoCurrent
71335-2026-571335202605120 TABLET, FILM COATED in 1 BOTTLE (71335-2026-5) 2022-02-100000-00-00NoNoCurrent
71335-2026-671335202606180 TABLET, FILM COATED in 1 BOTTLE (71335-2026-6) 2022-02-100000-00-00NoNoCurrent
71335-2026-77133520260710 TABLET, FILM COATED in 1 BOTTLE (71335-2026-7) 2022-02-100000-00-00NoNoCurrent