NDC 0093-8117

Famciclovir

Famciclovir

Famciclovir is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Famciclovir.

Product ID0093-8117_12c8f576-d5d0-48ca-bf70-260fe4ad8ef7
NDC0093-8117
Product TypeHuman Prescription Drug
Proprietary NameFamciclovir
Generic NameFamciclovir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-09-05
Marketing CategoryANDA / ANDA
Application NumberANDA077487
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameFAMCICLOVIR
Active Ingredient Strength125 mg/1
Pharm ClassesDNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0093-8117-56

30 TABLET, FILM COATED in 1 BOTTLE (0093-8117-56)
Marketing Start Date2007-09-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-8117-56 [00093811756]

Famciclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077487
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-09-05

NDC 0093-8117-01 [00093811701]

Famciclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077487
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-09-05
Marketing End Date2009-06-16

NDC 0093-8117-35 [00093811735]

Famciclovir TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077487
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-09-05
Marketing End Date2009-06-16

Drug Details

Active Ingredients

IngredientStrength
FAMCICLOVIR125 mg/1

OpenFDA Data

SPL SET ID:3f02042f-8f51-4ccf-b608-5dcd75d100fb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199193
  • 199192
  • 198382
  • Pharmacological Class

    • DNA Polymerase Inhibitors [MoA]
    • Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
    • Nucleoside Analog [EXT]
    • DNA Polymerase Inhibitors [MoA]
    • Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
    • Nucleoside Analog [EXT]

    NDC Crossover Matching brand name "Famciclovir" or generic name "Famciclovir"

    NDCBrand NameGeneric Name
    0093-8117FamciclovirFamciclovir
    0093-8118FamciclovirFamciclovir
    0093-8119FamciclovirFamciclovir
    16714-614FamciclovirFamciclovir
    16714-615FamciclovirFamciclovir
    16714-616FamciclovirFamciclovir
    17856-0705FamciclovirFamciclovir
    17856-0706FamciclovirFamciclovir
    17856-0708FamciclovirFamciclovir
    31722-706FamciclovirFamciclovir
    31722-707FamciclovirFamciclovir
    31722-708FamciclovirFamciclovir
    33342-024FamciclovirFamciclovir
    33342-025FamciclovirFamciclovir
    33342-026FamciclovirFamciclovir
    42291-275FamciclovirFamciclovir
    42291-276FamciclovirFamciclovir
    42291-277FamciclovirFamciclovir
    42291-414FamciclovirFamciclovir
    42291-415FamciclovirFamciclovir
    42291-416FamciclovirFamciclovir
    50090-3066FamciclovirFamciclovir
    50090-3337FamciclovirFamciclovir
    69097-271FAMCICLOVIRFAMCICLOVIR
    69097-269FAMCICLOVIRFAMCICLOVIR
    69097-272FAMCICLOVIRFAMCICLOVIR
    55289-168FamciclovirFamciclovir
    57237-194FamciclovirFamciclovir
    57237-195FamciclovirFamciclovir
    57237-196FamciclovirFamciclovir
    60429-360FAMCICLOVIRFAMCICLOVIR
    60429-361FAMCICLOVIRFAMCICLOVIR
    60429-359FAMCICLOVIRFAMCICLOVIR
    60505-3245FAMCICLOVIRFAMCICLOVIR
    60505-3246FAMCICLOVIRFAMCICLOVIR
    60505-3247FAMCICLOVIRFAMCICLOVIR
    60687-103FAMCICLOVIRFAMCICLOVIR
    63187-998FamciclovirFamciclovir
    63187-919FAMCICLOVIRFAMCICLOVIR
    63187-920FAMCICLOVIRFAMCICLOVIR
    63629-7890FamciclovirFamciclovir
    64980-351FamciclovirFamciclovir
    64980-350FamciclovirFamciclovir
    64980-349FamciclovirFamciclovir
    65862-466FamciclovirFamciclovir
    65862-467FamciclovirFamciclovir
    65862-465FamciclovirFamciclovir

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