NDC 0085-1318

REBETOL

Ribavirin

REBETOL is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Ribavirin.

Product ID0085-1318_3380c831-db90-4ac0-9c2f-398a00137e58
NDC0085-1318
Product TypeHuman Prescription Drug
Proprietary NameREBETOL
Generic NameRibavirin
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2003-07-29
Marketing CategoryNDA / NDA
Application NumberNDA021546
Labeler NameMerck Sharp & Dohme Corp.
Substance NameRIBAVIRIN
Active Ingredient Strength40 mg/mL
Pharm ClassesNucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0085-1318-01

1 BOTTLE in 1 CARTON (0085-1318-01) > 100 mL in 1 BOTTLE
Marketing Start Date2003-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0085-1318-01 [00085131801]

REBETOL LIQUID
Marketing CategoryNDA
Application NumberNDA021546
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2003-07-29

Drug Details

Active Ingredients

IngredientStrength
RIBAVIRIN40 mg/mL

OpenFDA Data

SPL SET ID:04d2b6f4-bd9b-4871-9527-92c81aa2d4d0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312817
  • 352007
  • 248112
  • 544400
    • UPC Code
  • 0300851194034
  • 0300851351055

    • Pharmacological Class

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

    NDC Crossover Matching brand name "REBETOL" or generic name "Ribavirin"

    NDCBrand NameGeneric Name
    0085-1318REBETOLribavirin
    0074-3197ModeribaRibavirin
    0074-3282ModeribaRibavirin
    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

    Trademark Results [REBETOL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    REBETOL
    REBETOL
    76469995 2747044 Dead/Cancelled
    SCHERING CORPORATION
    2002-11-25
    REBETOL
    REBETOL
    75067177 2154130 Live/Registered
    MERCK SHARP & DOHME CORP.
    1996-03-04
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.