NDC 0178-0902

Thiola EC

Tiopronin

Thiola EC is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Mission Pharmacal Company. The primary component is Tiopronin.

Product ID0178-0902_0f5c7e8c-aea7-410d-b45c-9646d29e1d78
NDC0178-0902
Product TypeHuman Prescription Drug
Proprietary NameThiola EC
Generic NameTiopronin
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2019-06-28
Marketing CategoryNDA / NDA
Application NumberNDA211843
Labeler NameMission Pharmacal Company
Substance NameTIOPRONIN
Active Ingredient Strength100 mg/1
Pharm ClassesCystine Disulfide Reduction [MoA],N-substituted Glycines [CS],Reducing and Complexing Thiol [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0178-0902-01

300 TABLET, DELAYED RELEASE in 1 BOTTLE (0178-0902-01)
Marketing Start Date2019-06-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0178-0902-01 [00178090201]

Thiola EC TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA211843
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-28

Drug Details

Active Ingredients

IngredientStrength
TIOPRONIN100 mg/1

OpenFDA Data

SPL SET ID:20298a52-a194-a161-8632-d84b6f26e23c
Manufacturer
UNII
UPC Code
  • 0301780901908
  • 0301780902011
  • Pharmacological Class

    • Cystine Disulfide Reduction [MoA]
    • N-substituted Glycines [CS]
    • Reducing and Complexing Thiol [EPC]
    • Cystine Disulfide Reduction [MoA]
    • N-substituted Glycines [CS]
    • Reducing and Complexing Thiol [EPC]

    NDC Crossover Matching brand name "Thiola EC" or generic name "Tiopronin"

    NDCBrand NameGeneric Name
    0178-0901Thiola ECtiopronin
    0178-0902Thiola ECtiopronin
    0178-0900Thiolatiopronin
    0093-7909TioproninTiopronin

    Trademark Results [Thiola EC]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    THIOLA EC
    THIOLA EC
    88068538 5904582 Live/Registered
    Mission Pharmacal Company
    2018-08-07

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