FDA.reportPublic FDA data

Carvedilol

Product NDC
0904-7305
11-digit product format
009047305
Labeler code
0904
Product ID
0904-7305_9eee2f7d-7fe9-4b09-a688-d17e8a9f44ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078251
Marketing category
ANDA
Marketing start
2024-07-01
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
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
0904-7305-61Carvedilol1 in 1 BLISTER PACKTABLET, FILM COATED15
0904-7305-61Carvedilol100 in 1 CARTONTABLET, FILM COATED1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7305-61EA - Each0904-730552cedab1-aba8-464c-b0b5-e5f45c3343cf12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7305CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS]3Current NDC, 2 package rows20240925_ec6d8d73-9d18-4a9e-ae0c-0ea12059e78e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSNec6d8d73-9d18-4a9e-ae0c-0ea12059e78e5
200033carvedilol 25 MG Oral TabletPSNec6d8d73-9d18-4a9e-ae0c-0ea12059e78e5
686924carvedilol 3.125 MG Oral TabletPSNec6d8d73-9d18-4a9e-ae0c-0ea12059e78e5
200031carvedilol 6.25 MG Oral TabletPSNec6d8d73-9d18-4a9e-ae0c-0ea12059e78e5
200032carvedilol 12.5 MG Oral TabletSCDec6d8d73-9d18-4a9e-ae0c-0ea12059e78e5
200033carvedilol 25 MG Oral TabletSCDec6d8d73-9d18-4a9e-ae0c-0ea12059e78e5
686924carvedilol 3.125 MG Oral TabletSCDec6d8d73-9d18-4a9e-ae0c-0ea12059e78e5
200031carvedilol 6.25 MG Oral TabletSCDec6d8d73-9d18-4a9e-ae0c-0ea12059e78e5
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
0904-7305-6100904730561100 BLISTER PACK in 1 CARTON (0904-7305-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2024-07-01NoNoHistorical