FAMCICLOVIR
These highlights do not include all the information needed to use FAMCICLOVIR TABLETS safely and effectively. See full prescribing information for FAMCICLOVIR TABLETS. FAMCICLOVIR tablets, Initial U.S. Approval: 1994
Approved
Approval ID
a5c46194-3692-cd26-0d85-6371974ccc44
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FAMCICLOVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-3245
Application NumberANDA091480
Product Classification
M
Marketing Category
C73584
G
Generic Name
FAMCICLOVIR
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (6)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FAMCICLOVIRActive
Quantity: 125 mg in 1 1
Code: QIC03ANI02
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FAMCICLOVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-3246
Application NumberANDA091480
Product Classification
M
Marketing Category
C73584
G
Generic Name
FAMCICLOVIR
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (6)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
FAMCICLOVIRActive
Quantity: 250 mg in 1 1
Code: QIC03ANI02
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FAMCICLOVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-3247
Application NumberANDA091480
Product Classification
M
Marketing Category
C73584
G
Generic Name
FAMCICLOVIR
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (6)
FAMCICLOVIRActive
Quantity: 500 mg in 1 1
Code: QIC03ANI02
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT