NDC 67457-163

Sotradecol

Tetradecyl Hydrogen Sulfate (ester)

Sotradecol is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Tetradecyl Hydrogen Sulfate (ester).

• Product ID: 67457-163_5450f902-fb17-44b8-8c4b-4fefeed1908e
• NDC: 67457-163
• 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: Mylan Institutional LLC
• Substance Name: TETRADECYL HYDROGEN SULFATE (ESTER)
• Active Ingredient Strength: 30 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 67457-163-02

5 VIAL, MULTI-DOSE in 1 CARTON (67457-163-02) > 2 mL in 1 VIAL, MULTI-DOSE (67457-163-00)

• Marketing Start Date: 2013-04-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-163-00 [67457016300]

Sotradecol INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA040541
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-12-19

NDC 67457-163-02 [67457016302]

Sotradecol INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA040541
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-04-29

Drug Details

Active Ingredients

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

OpenFDA Data

• SPL SET ID: f1756c28-dcd2-4b49-be62-07ca20682018
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • 6326W0DRHY
• RxNorm Concept Unique ID - RxCUI:
  • 543739
  • 543732
  • 204491
  • 204490

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)