FDA.reportPublic FDA data

Carvedilol

Product NDC
51655-397
11-digit product format
516550397
Labeler code
51655
Product ID
51655-397_49dc05cf-35ca-a384-e063-6294a90a07e1
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
2020-07-08
Substance
CARVEDILOL
Active strength
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
2027-12-31
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
CARVEDILOL25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200033

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
51655-397-252026-01-29C16284748780-1f386c649-fdc1-0266-e053-dadaa90a7c1aThese 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
51655-397-262026-01-29C16284748780-1f386c649-fdc1-0266-e053-dadaa90a7c1aThese 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
51655-397-522026-01-29C16284748780-1f386c649-fdc1-0266-e053-dadaa90a7c1aThese 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
51655-397-832026-01-29C16284748780-1f386c649-fdc1-0266-e053-dadaa90a7c1aThese 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
51655-397-262023-03-20C16284748780-1f386c649-fdc1-0266-e053-dadaa90a7c1aThese 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
51655-397-262023-01-30C16284748780-1f386c649-fdc1-0266-e053-dadaa90a7c1aThese 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
51655-397-25Carvedilol60 in 1 BOTTLE, PLASTICTABLET, FILM COATED605
51655-397-26Carvedilol90 in 1 BOTTLE, PLASTICTABLET, FILM COATED905
51655-397-52Carvedilol30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305
51655-397-83Carvedilol180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-397CARVEDILOL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 4 package rows20240723_b0887c72-bc6a-010d-e053-2995a90aab8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200033carvedilol 25 MG Oral TabletPSNb0887c72-bc6a-010d-e053-2995a90aab8d5
200033carvedilol 25 MG Oral TabletSCDb0887c72-bc6a-010d-e053-2995a90aab8d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-397-255165503972560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-25) 2022-02-09NoNoCurrent
51655-397-265165503972690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-26) 2020-07-080000-00-00NoNoCurrent
51655-397-525165503975230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-52) 2022-02-09NoNoCurrent
51655-397-8351655039783180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-83) 2023-03-10NoNoCurrent