FDA.reportPublic FDA data

Carvedilol

Product NDC
51655-030
11-digit product format
516550030
Labeler code
51655
Product ID
51655-030_46dd9f29-5a09-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
2022-03-23
Substance
CARVEDILOL
Active strength
12.5 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
CARVEDILOL12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200032

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
51655-030-25Carvedilol60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604
51655-030-26Carvedilol90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904
51655-030-52Carvedilol30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304
51655-030-83Carvedilol180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-030CARVEDILOL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 4 package rows20240704_df600dde-8ef9-52e3-e053-2a95a90a2dc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSNdf600dde-8ef9-52e3-e053-2a95a90a2dc04
200032carvedilol 12.5 MG Oral TabletSCDdf600dde-8ef9-52e3-e053-2a95a90a2dc04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-030-255165500302560 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-030-25) 2022-04-130000-00-00NoNoCurrent
51655-030-265165500302690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-030-26) 2022-07-14NoNoHistorical
51655-030-525165500305230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-030-52) 2022-03-230000-00-00NoNoCurrent
51655-030-8351655003083180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-030-83) 2022-04-130000-00-00NoNoCurrent