Carvedilol

Product NDC
51655-943
11-digit product format
516550943
Labeler code
51655
Product ID
51655-943_497471bb-541b-f945-e063-6294a90adbb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078384
Marketing category
ANDA
Marketing start
2022-03-30
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
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
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
51655-943-18Carvedilol180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-943CARVEDILOL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20231115_df7415ac-e475-19c9-e053-2995a90afa71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSNdf7415ac-e475-19c9-e053-2995a90afa713
200031carvedilol 6.25 MG Oral TabletSCDdf7415ac-e475-19c9-e053-2995a90afa713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-943-1851655094318180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-943-18) 2022-03-300000-00-00NoNoCurrent