(sotradecol) sodium tetradecyl sulfate

Generic: (sotradecol) sodium tetradecyl sulfate

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name (sotradecol) sodium tetradecyl sulfate
Generic Name (sotradecol) sodium tetradecyl sulfate
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tetradecyl hydrogen sulfate (ester) 30 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1563
Product ID 51662-1563_c59db022-bda9-1732-e053-2a95a90a24f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040541
Listing Expiration 2026-12-31
Marketing Start 2021-06-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621563
Hyphenated Format 51662-1563

Supplemental Identifiers

RxCUI
204491
UNII
6326W0DRHY

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) sodium tetradecyl sulfate (source: ndc)
Generic Name (sotradecol) sodium tetradecyl sulfate (source: ndc)
Application Number ANDA040541 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 30 mg/mL
source: ndc
Packaging
  • 2 mL in 1 VIAL, MULTI-DOSE (51662-1563-1)
source: ndc

Packages (1)

51662-1563-1 2 mL in 1 VIAL, MULTI-DOSE (51662-1563-1)

Ingredients (1)

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

Linked Drug Pages (1)

(SOTRADECOL) SODIUM TETRADECYL SULFATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "c59db022-bda9-1732-e053-2a95a90a24f8", "openfda": {"unii": ["6326W0DRHY"], "rxcui": ["204491"], "spl_set_id": ["c59db022-bda8-1732-e053-2a95a90a24f8"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "2 mL in 1 VIAL, MULTI-DOSE (51662-1563-1)", "package_ndc": "51662-1563-1", "marketing_start_date": "20210625"}], "brand_name": "(SOTRADECOL) SODIUM TETRADECYL SULFATE", "product_id": "51662-1563_c59db022-bda9-1732-e053-2a95a90a24f8", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "51662-1563", "generic_name": "(SOTRADECOL) SODIUM TETRADECYL SULFATE", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "(SOTRADECOL) SODIUM TETRADECYL SULFATE", "active_ingredients": [{"name": "TETRADECYL HYDROGEN SULFATE (ESTER)", "strength": "30 mg/mL"}], "application_number": "ANDA040541", "marketing_category": "ANDA", "marketing_start_date": "20210625", "listing_expiration_date": "20261231"}