sotradecol

Generic: tetradecyl hydrogen sulfate (ester)

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotradecol
Generic Name tetradecyl hydrogen sulfate (ester)
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tetradecyl hydrogen sulfate (ester) 30 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-163
Product ID 67457-163_ddecdc4b-0bd4-4b20-a0ac-3c0fa542c14f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040541
Listing Expiration 2026-12-31
Marketing Start 2013-04-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457163
Hyphenated Format 67457-163

Supplemental Identifiers

RxCUI
204490 204491 543732 543739
UNII
6326W0DRHY

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sotradecol (source: ndc)
Generic Name tetradecyl hydrogen sulfate (ester) (source: ndc)
Application Number ANDA040541 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 30 mg/mL
source: ndc
Packaging
  • 5 VIAL, MULTI-DOSE in 1 CARTON (67457-163-02) / 2 mL in 1 VIAL, MULTI-DOSE (67457-163-00)
source: ndc

Packages (1)

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

Ingredients (1)

tetradecyl hydrogen sulfate (ester) (30 mg/mL)

Linked Drug Pages (1)

Sotradecol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ddecdc4b-0bd4-4b20-a0ac-3c0fa542c14f", "openfda": {"unii": ["6326W0DRHY"], "rxcui": ["204490", "204491", "543732", "543739"], "spl_set_id": ["f1756c28-dcd2-4b49-be62-07ca20682018"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, MULTI-DOSE in 1 CARTON (67457-163-02)  / 2 mL in 1 VIAL, MULTI-DOSE (67457-163-00)", "package_ndc": "67457-163-02", "marketing_start_date": "20130429"}], "brand_name": "Sotradecol", "product_id": "67457-163_ddecdc4b-0bd4-4b20-a0ac-3c0fa542c14f", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "67457-163", "generic_name": "tetradecyl hydrogen sulfate (ester)", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotradecol", "active_ingredients": [{"name": "TETRADECYL HYDROGEN SULFATE (ESTER)", "strength": "30 mg/mL"}], "application_number": "ANDA040541", "marketing_category": "ANDA", "marketing_start_date": "20130429", "listing_expiration_date": "20261231"}