NDC 61958-1501

Sovaldi

Sofosbuvir

Sovaldi is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Gilead Sciences, Inc.. The primary component is Sofosbuvir.

Product ID61958-1501_10e67d0d-c67d-4971-a948-b733c476e603
NDC61958-1501
Product TypeHuman Prescription Drug
Proprietary NameSovaldi
Generic NameSofosbuvir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-12-06
Marketing CategoryNDA / NDA
Application NumberNDA204671
Labeler NameGilead Sciences, Inc.
Substance NameSOFOSBUVIR
Active Ingredient Strength400 mg/1
Pharm ClassesHepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC],RNA Replicase Inhibitors [MoA],Nucleoside Analog [EXT]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 61958-1501-1

28 TABLET, FILM COATED in 1 BOTTLE (61958-1501-1)
Marketing Start Date2013-12-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61958-1501-1 [61958150101]

Sovaldi TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204671
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-06

Drug Details

Active Ingredients

IngredientStrength
SOFOSBUVIR400 mg/1

OpenFDA Data

SPL SET ID:80beab2c-396e-4a37-a4dc-40fdb62859cf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1484916
  • 1484922
  • Pharmacological Class

    • Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]
    • RNA Replicase Inhibitors [MoA]
    • Nucleoside Analog [EXT]

    Medicade Reported Pricing

    61958150101 SOVALDI 400 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Sovaldi" or generic name "Sofosbuvir"

    NDCBrand NameGeneric Name
    61958-1501SovaldiSOFOSBUVIR
    61958-1503SovaldiSOFOSBUVIR
    61958-1504SovaldiSOFOSBUVIR
    61958-1505SovaldiSOFOSBUVIR

    Trademark Results [Sovaldi]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SOVALDI
    SOVALDI
    85709308 4468665 Live/Registered
    GILEAD SCIENCES IRELAND UC
    2012-08-21

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