NDC 50090-4525

Sotradecol

Tetradecyl Hydrogen Sulfate (ester)

Sotradecol is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Tetradecyl Hydrogen Sulfate (ester).

Product ID50090-4525_3305d92f-0d6f-454c-81ea-bbad295b513b
NDC50090-4525
Product TypeHuman Prescription Drug
Proprietary NameSotradecol
Generic NameTetradecyl Hydrogen Sulfate (ester)
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2013-04-29
Marketing CategoryANDA / ANDA
Application NumberANDA040541
Labeler NameA-S Medication Solutions
Substance NameTETRADECYL HYDROGEN SULFATE (ESTER)
Active Ingredient Strength10 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50090-4525-0

2 mL in 1 VIAL, MULTI-DOSE (50090-4525-0)
Marketing Start Date2019-09-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-4525-0 [50090452500]

Sotradecol INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040541
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-16

Drug Details

Active Ingredients

IngredientStrength
TETRADECYL HYDROGEN SULFATE (ESTER)10 mg/mL

OpenFDA Data

SPL SET ID:23b7b990-2ecc-4b3a-8233-03c3b2584800
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 543732
  • 204490
  • NDC Crossover Matching brand name "Sotradecol" or generic name "Tetradecyl Hydrogen Sulfate (ester)"

    NDCBrand NameGeneric Name
    50090-4525Sotradecoltetradecyl hydrogen sulfate (ester)
    50090-4529Sotradecoltetradecyl hydrogen sulfate (ester)
    67457-162Sotradecoltetradecyl hydrogen sulfate (ester)
    67457-163Sotradecoltetradecyl hydrogen sulfate (ester)

    Trademark Results [Sotradecol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SOTRADECOL
    SOTRADECOL
    76385054 3123924 Live/Registered
    MYLAN PHARMA GROUP LIMITED
    2002-03-20
    SOTRADECOL
    SOTRADECOL
    71497429 0428131 Dead/Cancelled
    WALLACE & TIERNAN PRODUCTS INCORPORATED
    1946-02-28

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