NDC 50090-4529

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 ID: 50090-4529_3b5a236b-0e5f-4f2c-bef5-4170fa5fd597
• NDC: 50090-4529
• Product Type: Human Prescription Drug
• Proprietary Name: Sotradecol
• Generic Name: Tetradecyl Hydrogen Sulfate (ester)
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2013-04-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040541
• Labeler Name: A-S Medication Solutions
• Substance Name: TETRADECYL HYDROGEN SULFATE (ESTER)
• Active Ingredient Strength: 30 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50090-4529-0

2 mL in 1 VIAL, MULTI-DOSE (50090-4529-0)

• Marketing Start Date: 2019-09-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-4529-0 [50090452900]

Sotradecol INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA040541
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-09-17

Drug Details

Active Ingredients

Ingredient	Strength
TETRADECYL HYDROGEN SULFATE (ESTER)	30 mg/mL

OpenFDA Data

• SPL SET ID: 6538eda0-92c4-4dde-b1b4-23de4a5b4c7e
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • 6326W0DRHY
• RxNorm Concept Unique ID - RxCUI:
  • 204491
  • 543739

NDC Crossover Matching brand name "Sotradecol" or generic name "Tetradecyl Hydrogen Sulfate (ester)"

NDC	Brand Name	Generic Name
50090-4525	Sotradecol	tetradecyl hydrogen sulfate (ester)
50090-4529	Sotradecol	tetradecyl hydrogen sulfate (ester)
67457-162	Sotradecol	tetradecyl hydrogen sulfate (ester)
67457-163	Sotradecol	tetradecyl hydrogen sulfate (ester)