FDA.reportPublic FDA data

Carvedilol

Product NDC
51655-029
11-digit product format
516550029
Labeler code
51655
Product ID
51655-029_46dd9f29-5a08-f939-e063-6394a90a6768
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA077614
Marketing category
ANDA
Marketing start
2015-02-09
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-029-522023-02-06C16284748780-19d75b9d0-2d79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use Initial U.S. Approval: 1995
51655-029-522020-01-31C16284748780-19d75b9d0-2d79-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-029-25Carvedilol60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604
51655-029-26Carvedilol90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904
51655-029-52Carvedilol30 in 1 BOTTLE, DISPENSINGTABLET, FILM COATED304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-029CARVEDILOL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 3 package rows20240704_a570b8ea-530d-4565-a091-bb9dbe4a6d8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSNa570b8ea-530d-4565-a091-bb9dbe4a6d8d4
200031carvedilol 6.25 MG Oral TabletSCDa570b8ea-530d-4565-a091-bb9dbe4a6d8d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-029-255165500292560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-029-25) 2022-09-09NoNoHistorical
51655-029-265165500292690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-029-26) 2022-11-22NoNoHistorical
51655-029-525165500295230 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-029-52) 2015-02-09NoNoHistorical