Carvedilol
Carvedilol
Approved
Approval ID
e5e766e3-ef75-4100-e053-2995a90a510f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 10, 2022
Manufacturers
FDA
Direct_Rx
DUNS: 079254320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Carvedilol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72189-372
Application NumberANDA078227
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carvedilol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2022
FDA Product Classification
INGREDIENTS (10)
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CARVEDILOLActive
Quantity: 12.5 mg in 1 1
Code: 0K47UL67F2
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT