Carvedilol

Product NDC
51655-713
11-digit product format
516550713
Labeler code
51655
Product ID
51655-713_4b94c210-6abd-cbea-e063-6294a90aa7ce
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
2021-05-28
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
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
CARVEDILOL3.125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui686924

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
51655-713-25Carvedilol60 in 1 BOTTLE, PLASTICTABLET, FILM COATED605
51655-713-52Carvedilol30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-713CARVEDILOL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20241228_db5d9e64-46b3-92d3-e053-2995a90a74bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686924carvedilol 3.125 MG Oral TabletPSNdb5d9e64-46b3-92d3-e053-2995a90a74bc5
686924carvedilol 3.125 MG Oral TabletSCDdb5d9e64-46b3-92d3-e053-2995a90a74bc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-713-255165507132560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-713-25) 2022-04-15NoNoCurrent
51655-713-525165507135230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-713-52) 2021-05-28NoNoCurrent