DIGOXIN
DIGOXIN - digoxin tablet West-ward Pharmaceutical Corp. ---------- DIGOXIN TABLETS, USP Revised 05/08 Rx Only
Approved
Approval ID
f322ff90-e08d-4d99-9348-94cc6a56afcd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2009
Manufacturers
FDA
DEPT HEALTH CENTRAL PHARMACY
DUNS: 829348114
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 Code53808-0165
Application NumberANDA077002
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIGOXIN
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2009
FDA Product Classification
INGREDIENTS (8)
DIGOXINActive
Quantity: 125 ug in 1 1
Code: 73K4184T59
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT