NDC 66435-105

RIBASPHERE RibaPak

Ribavirin

RIBASPHERE RibaPak is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Kadmon Pharmaceuticals, Llc. The primary component is Ribavirin.

Product ID66435-105_dffc1bdc-d81c-457e-ace7-ee5c6032f7b0
NDC66435-105
Product TypeHuman Prescription Drug
Proprietary NameRIBASPHERE RibaPak
Generic NameRibavirin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA077456
Labeler NameKadmon Pharmaceuticals, LLC
Substance NameRIBAVIRIN
Active Ingredient Strength400 mg/1
Pharm ClassesNucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 66435-105-99

4 DOSE PACK in 1 CARTON (66435-105-99) > 14 TABLET in 1 DOSE PACK (66435-105-56)
Marketing Start Date2010-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66435-105-56 [66435010556]

RIBASPHERE RibaPak TABLET
Marketing CategoryANDA
Application NumberANDA077456
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-01-01
Marketing End Date2019-09-30

NDC 66435-105-99 [66435010599]

RIBASPHERE RibaPak TABLET
Marketing CategoryANDA
Application NumberANDA077456
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-01-01
Marketing End Date2019-09-30

Drug Details

Active Ingredients

IngredientStrength
RIBAVIRIN400 mg/1

OpenFDA Data

SPL SET ID:12f3dec1-4299-4b93-8013-6fa6a963fd81
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616133
  • 616131
  • 896790
  • 902313
  • 902312
  • 248109
  • 616129
  • 1863148
  • 1298334
  • 757599
  • 597718
  • 754738
  • 597722
  • 757597
  • Pharmacological Class

    • Nucleoside Analog [EXT]
    • Nucleoside Analog Antiviral [EPC]

    NDC Crossover Matching brand name "RIBASPHERE RibaPak" or generic name "Ribavirin"

    NDCBrand NameGeneric Name
    66435-106RIBASPHERE RibaPakRIBASPHERE RibaPak
    66435-108RIBASPHERE RibaPakRIBASPHERE RibaPak
    66435-105RIBASPHERE RibaPakRIBASPHERE RibaPak
    66435-107RIBASPHERE RibaPakRIBASPHERE RibaPak
    0074-3197ModeribaRibavirin
    0074-3282ModeribaRibavirin
    0085-1318REBETOLribavirin
    0781-2043RibavirinRibavirin
    0781-5177RibavirinRibavirin
    42494-423RibavirinRibavirin
    53808-0781RibavirinRIBAVIRIN
    53808-0782RibavirinRIBAVIRIN
    54738-950ribavirinribavirin
    54738-951ribavirinribavirin
    54738-952ribavirinribavirin
    54738-953ribavirinribavirin
    63629-2149RibavirinRibavirin
    65841-046RibavirinRibavirin
    65841-129RibavirinRibavirin
    65841-260RibavirinRibavirin
    65841-603RibavirinRibavirin
    65841-632RibavirinRibavirin
    65862-207RibavirinRibavirin
    0187-0007VirazoleRibavirin

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