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 tablet, for oral use Initial U.S. Approval: 1994
Approved
Approval ID
2337e2f6-039b-4f5c-bca4-b0771c4cb632
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 5, 2021
Manufacturers
FDA
ATLANTIC BIOLOGICALS CORP.
DUNS: 047437707
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 Code17856-0705
Application NumberANDA202438
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famciclovir
Product Specifications
Route of AdministrationORAL
Effective DateApril 5, 2021
FDA Product Classification
INGREDIENTS (9)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FAMCICLOVIRActive
Quantity: 250 mg in 1 1
Code: QIC03ANI02
Classification: ACTIB
Famciclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17856-0706
Application NumberANDA202438
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famciclovir
Product Specifications
Route of AdministrationORAL
Effective DateApril 5, 2021
FDA Product Classification
INGREDIENTS (9)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FAMCICLOVIRActive
Quantity: 125 mg in 1 1
Code: QIC03ANI02
Classification: ACTIB
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Famciclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17856-0708
Application NumberANDA202438
Product Classification
M
Marketing Category
C73584
G
Generic Name
Famciclovir
Product Specifications
Route of AdministrationORAL
Effective DateApril 5, 2021
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FAMCICLOVIRActive
Quantity: 500 mg in 1 1
Code: QIC03ANI02
Classification: ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT