Carvedilol

Product NDC
55154-2640
11-digit product format
551542640
Labeler code
55154
Product ID
55154-2640_24841214-58d6-40aa-b265-9b1fd6b21945
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA078251
Marketing category
ANDA
Marketing start
2024-12-10
Substance
CARVEDILOL
Active strength
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
CARVEDILOL25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200031, 200032, 200033, 686924

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
55154-2640-0Carvedilol1 in 1 BLISTER PACKTABLET, FILM COATED14
55154-2640-0Carvedilol10 in 1 BAGTABLET, FILM COATED104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2640CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]2Current NDC, 2 package rows20250523_bd0f2596-a192-4b0e-836f-4a09816408a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSNbd0f2596-a192-4b0e-836f-4a09816408a44
200033carvedilol 25 MG Oral TabletPSNbd0f2596-a192-4b0e-836f-4a09816408a44
686924carvedilol 3.125 MG Oral TabletPSNbd0f2596-a192-4b0e-836f-4a09816408a44
200031carvedilol 6.25 MG Oral TabletPSNbd0f2596-a192-4b0e-836f-4a09816408a44
200032carvedilol 12.5 MG Oral TabletSCDbd0f2596-a192-4b0e-836f-4a09816408a44
200033carvedilol 25 MG Oral TabletSCDbd0f2596-a192-4b0e-836f-4a09816408a44
686924carvedilol 3.125 MG Oral TabletSCDbd0f2596-a192-4b0e-836f-4a09816408a44
200031carvedilol 6.25 MG Oral TabletSCDbd0f2596-a192-4b0e-836f-4a09816408a44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-2640-05515426400010 BLISTER PACK in 1 BAG (55154-2640-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2024-12-10NoNoHistorical