FDA.reportPublic FDA data

Carvedilol

Product NDC
50090-6742
11-digit product format
500906742
Labeler code
50090
Product ID
50090-6742_9112f0ee-5f25-4556-90ea-d1020154f0c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077614
Marketing category
ANDA
Marketing start
2007-09-05
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6742-0Carvedilol60 in 1 BOTTLETABLET, FILM COATED606
50090-6742-1Carvedilol180 in 1 BOTTLETABLET, FILM COATED1806
50090-6742-3Carvedilol30 in 1 BOTTLETABLET, FILM COATED306
50090-6742-4Carvedilol90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6742CARVEDILOL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Current NDC, 4 package rows20231018_64ba2b17-989e-443c-8277-9649489b5ce8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSN64ba2b17-989e-443c-8277-9649489b5ce86
200031carvedilol 6.25 MG Oral TabletSCD64ba2b17-989e-443c-8277-9649489b5ce86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6742-05009067420060 TABLET, FILM COATED in 1 BOTTLE (50090-6742-0) 2023-10-13NoNoCurrent
50090-6742-150090674201180 TABLET, FILM COATED in 1 BOTTLE (50090-6742-1) 2023-10-13NoNoCurrent
50090-6742-35009067420330 TABLET, FILM COATED in 1 BOTTLE (50090-6742-3) 2023-10-13NoNoCurrent
50090-6742-45009067420490 TABLET, FILM COATED in 1 BOTTLE (50090-6742-4) 2023-10-13NoNoCurrent