(SOTRADECOL) SODIUM TETRADECYL SULFATE

Product NDC
51662-1563
11-digit product format
516621563
Labeler code
51662
Product ID
51662-1563_c59db022-bda9-1732-e053-2a95a90a24f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
(SOTRADECOL) SODIUM TETRADECYL SULFATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA040541
Marketing category
ANDA
Marketing start
2021-06-25
Substance
TETRADECYL HYDROGEN SULFATE (ESTER)
Active strength
30 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
(SOTRADECOL) SODIUM TETRADECYL SULFATE
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6326W0DRHY
Rxcui204491

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
6ab7971f-36bb-4938-80a6-13935f0c3f67Product name120200526
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1563-1(SOTRADECOL) SODIUM TETRADECYL SULFATE2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1563(SOTRADECOL) SODIUM TETRADECYL SULFATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]1Current NDC, Legacy NDC, 1 package rows20210627_c59db022-bda8-1732-e053-2a95a90a24f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204491sodium tetradecyl sulfate 3 % Injectable SolutionPSNc59db022-bda8-1732-e053-2a95a90a24f81
204491sodium tetradecyl sulfate 30 MG/ML Injectable SolutionSCDc59db022-bda8-1732-e053-2a95a90a24f81
204491sodium tetradecyl sulfate 3 % Injectable SolutionSYc59db022-bda8-1732-e053-2a95a90a24f81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1563-1516621563012 mL in 1 VIAL, MULTI-DOSE (51662-1563-1) 2 ml2021-06-250000-00-00NoNoCurrent