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, for oral use Initial U.S. Approval: 1994
Approved
Approval ID
d5c46506-a350-44a1-9440-d939da895f16
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2020
Manufacturers
FDA
Rising Pharmaceuticals, Inc.
DUNS: 041241766
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 Code64980-351
Application NumberANDA091114
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famciclovir
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2020
FDA Product Classification
INGREDIENTS (8)
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FAMCICLOVIRActive
Quantity: 500 mg in 1 1
Code: QIC03ANI02
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Famciclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-350
Application NumberANDA091114
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famciclovir
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2020
FDA Product Classification
INGREDIENTS (8)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FAMCICLOVIRActive
Quantity: 250 mg in 1 1
Code: QIC03ANI02
Classification: ACTIB
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
Famciclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64980-349
Application NumberANDA091114
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famciclovir
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2020
FDA Product Classification
INGREDIENTS (8)
FAMCICLOVIRActive
Quantity: 125 mg in 1 1
Code: QIC03ANI02
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT