Carvedilol

Product NDC
68788-9789
11-digit product format
687889789
Labeler code
68788
Product ID
68788-9789_8cbf4bb1-72f2-4e70-9a43-ba62d8fb3317
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals,Inc.
Application
ANDA077614
Marketing category
ANDA
Marketing start
2012-06-04
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, 200033

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
68788-9789-1Carvedilol100 in 1 BOTTLETABLET, FILM COATED10014
68788-9789-3Carvedilol30 in 1 BOTTLETABLET, FILM COATED3014
68788-9789-6Carvedilol60 in 1 BOTTLETABLET, FILM COATED6014
68788-9789-9Carvedilol90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMINOLEVULINIC ACID HYDROCHLORIDEINACTIVE INGREDIENTV35KBM8JGRCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMINOMETRADINEINACTIVE INGREDIENTPPM8SX5Q3VCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMINOPENTAMIDE SULFATEINACTIVE INGREDIENT20P9NI883OCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMINOPHYLLINEINACTIVE INGREDIENT27Y3KJK423CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMINOPROMAZINEINACTIVE INGREDIENTS9SDD93U5UCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMINOPROPAZINE FUMARATEINACTIVE INGREDIENT9KWA4W69IWCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMINOPTERIN SODIUMINACTIVE INGREDIENTFZU1QI13O9CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMMI VISNAGA FRUITINACTIVE INGREDIENT3UN285QN0CCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
AMOPROXANINACTIVE INGREDIENT27RL57FCYMCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9789CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]14Current NDC, Legacy NDC, 4 package rows20250216_81bc612d-5674-45b9-a1f5-2cb4fa625747.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200033carvedilol 25 MG Oral TabletPSN81bc612d-5674-45b9-a1f5-2cb4fa62574714
200031carvedilol 6.25 MG Oral TabletPSN81bc612d-5674-45b9-a1f5-2cb4fa62574714
200033carvedilol 25 MG Oral TabletSCD81bc612d-5674-45b9-a1f5-2cb4fa62574714
200031carvedilol 6.25 MG Oral TabletSCD81bc612d-5674-45b9-a1f5-2cb4fa62574714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-9789-168788978901100 TABLET, FILM COATED in 1 BOTTLE (68788-9789-1) 2012-06-040000-00-00NoNoCurrent
68788-9789-36878897890330 TABLET, FILM COATED in 1 BOTTLE (68788-9789-3) 2012-06-040000-00-00NoNoCurrent
68788-9789-66878897890660 TABLET, FILM COATED in 1 BOTTLE (68788-9789-6) 2012-06-040000-00-00NoNoCurrent
68788-9789-96878897890990 TABLET, FILM COATED in 1 BOTTLE (68788-9789-9) 2012-06-040000-00-00NoNoCurrent