FDA.reportPublic FDA data

Carvedilol

Product NDC
71335-1128
11-digit product format
713351128
Labeler code
71335
Product ID
71335-1128_06540a82-d48f-46df-bf2c-04e8332ba9ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078251
Marketing category
ANDA
Marketing start
2007-09-05
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
Rxcui200032, 200033, 686924

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
71335-1128-1Carvedilol30 in 1 BOTTLETABLET, FILM COATED309
71335-1128-2Carvedilol100 in 1 BOTTLETABLET, FILM COATED1009
71335-1128-3Carvedilol180 in 1 BOTTLETABLET, FILM COATED1809
71335-1128-4Carvedilol60 in 1 BOTTLETABLET, FILM COATED609
71335-1128-5Carvedilol90 in 1 BOTTLETABLET, FILM COATED909
71335-1128-6Carvedilol120 in 1 BOTTLETABLET, FILM COATED1209

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1128CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 6 package rows20231209_b4e700f8-d0e0-4ad5-93b5-e935389a96e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSNb4e700f8-d0e0-4ad5-93b5-e935389a96e39
200033carvedilol 25 MG Oral TabletPSNb4e700f8-d0e0-4ad5-93b5-e935389a96e39
686924carvedilol 3.125 MG Oral TabletPSNb4e700f8-d0e0-4ad5-93b5-e935389a96e39
200032carvedilol 12.5 MG Oral TabletSCDb4e700f8-d0e0-4ad5-93b5-e935389a96e39
200033carvedilol 25 MG Oral TabletSCDb4e700f8-d0e0-4ad5-93b5-e935389a96e39
686924carvedilol 3.125 MG Oral TabletSCDb4e700f8-d0e0-4ad5-93b5-e935389a96e39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1128-17133511280130 TABLET, FILM COATED in 1 BOTTLE (71335-1128-1) 2019-03-120000-00-00NoNoCurrent
71335-1128-271335112802100 TABLET, FILM COATED in 1 BOTTLE (71335-1128-2) 2019-03-120000-00-00NoNoCurrent
71335-1128-371335112803180 TABLET, FILM COATED in 1 BOTTLE (71335-1128-3) 2019-03-120000-00-00NoNoCurrent
71335-1128-47133511280460 TABLET, FILM COATED in 1 BOTTLE (71335-1128-4) 2019-03-120000-00-00NoNoCurrent
71335-1128-57133511280590 TABLET, FILM COATED in 1 BOTTLE (71335-1128-5) 2019-03-120000-00-00NoNoCurrent
71335-1128-671335112806120 TABLET, FILM COATED in 1 BOTTLE (71335-1128-6) 2019-03-120000-00-00NoNoCurrent