Digoxin
Digoxin Tablets, USP125 mcg (0.125 mg)250 mcg (0.25 mg)
Approved
Approval ID
fb21e756-05bc-4d39-8199-6a2ce5e860db
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 14, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-5276
Application NumberANDA076268
Product Classification
M
Marketing Category
C73584
G
Generic Name
Digoxin
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2019
FDA Product Classification
INGREDIENTS (9)
DIGOXINActive
Quantity: 125 ug in 1 1
Code: 73K4184T59
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT