Digoxin
Digozin
Approved
Approval ID
cabd1834-7398-497e-b11f-221a25f21a4e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Digoxin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-678
Application NumberANDA075659
Product Classification
M
Marketing Category
C73584
G
Generic Name
Digoxin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2010
FDA Product Classification
INGREDIENTS (5)
DIGOXINActive
Quantity: 0.125 mg in 1 1
Code: 73K4184T59
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT