FDA.reportPublic FDA data

Carvedilol

Product NDC
71335-2101
11-digit product format
713352101
Labeler code
71335
Product ID
71335-2101_2f981ba4-8093-4e6c-b57a-dbc814213152
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077614
Marketing category
ANDA
Marketing start
2007-09-05
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
2026-12-31

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
71335-2101-1Carvedilol30 in 1 BOTTLETABLET, FILM COATED30104
71335-2101-2Carvedilol60 in 1 BOTTLETABLET, FILM COATED60104
71335-2101-3Carvedilol100 in 1 BOTTLETABLET, FILM COATED100104
71335-2101-4Carvedilol180 in 1 BOTTLETABLET, FILM COATED180104
71335-2101-5Carvedilol90 in 1 BOTTLETABLET, FILM COATED90104
71335-2101-6Carvedilol120 in 1 BOTTLETABLET, FILM COATED120104
71335-2101-7Carvedilol25 in 1 BOTTLETABLET, FILM COATED25104
71335-2101-8Carvedilol10 in 1 BOTTLETABLET, FILM COATED10104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2101CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 8 package rows20240823_da830b08-1cdd-4d36-a068-c376fd7763c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSNda830b08-1cdd-4d36-a068-c376fd7763c4104
200031carvedilol 6.25 MG Oral TabletSCDda830b08-1cdd-4d36-a068-c376fd7763c4104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2101-17133521010130 TABLET, FILM COATED in 1 BOTTLE (71335-2101-1) 2024-04-030000-00-00NoNoCurrent
71335-2101-27133521010260 TABLET, FILM COATED in 1 BOTTLE (71335-2101-2) 2022-07-140000-00-00NoNoCurrent
71335-2101-371335210103100 TABLET, FILM COATED in 1 BOTTLE (71335-2101-3) 2022-07-210000-00-00NoNoCurrent
71335-2101-471335210104180 TABLET, FILM COATED in 1 BOTTLE (71335-2101-4) 2023-11-170000-00-00NoNoCurrent
71335-2101-57133521010590 TABLET, FILM COATED in 1 BOTTLE (71335-2101-5) 2024-02-120000-00-00NoNoCurrent
71335-2101-671335210106120 TABLET, FILM COATED in 1 BOTTLE (71335-2101-6) 2022-07-080000-00-00NoNoCurrent
71335-2101-77133521010725 TABLET, FILM COATED in 1 BOTTLE (71335-2101-7) 2024-04-030000-00-00NoNoCurrent
71335-2101-87133521010810 TABLET, FILM COATED in 1 BOTTLE (71335-2101-8) 2024-04-030000-00-00NoNoCurrent