SODIUM TETRADECYL SULFATE

Product NDC
51662-1562
11-digit product format
516621562
Labeler code
51662
Product ID
51662-1562_1203bbfe-c55f-1bcb-e063-6394a90a6577
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM TETRADECYL SULFATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA040541
Marketing category
ANDA
Marketing start
2021-07-18
Substance
TETRADECYL HYDROGEN SULFATE (ESTER)
Active strength
10 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
SODIUM TETRADECYL SULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRADECYL HYDROGEN SULFATE (ESTER)10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6326W0DRHY
Rxcui204490

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
51662-1562-1SODIUM TETRADECYL SULFATE2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1562SODIUM TETRADECYL SULFATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, Legacy NDC, 1 package rows20240224_c76f4b3b-9f93-349f-e053-2995a90a2d57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204490sodium tetradecyl sulfate 1 % Injectable SolutionPSNc76f4b3b-9f93-349f-e053-2995a90a2d572
204490sodium tetradecyl sulfate 10 MG/ML Injectable SolutionSCDc76f4b3b-9f93-349f-e053-2995a90a2d572
204490sodium tetradecyl sulfate 1 % Injectable SolutionSYc76f4b3b-9f93-349f-e053-2995a90a2d572

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1562-1516621562012 mL in 1 VIAL, MULTI-DOSE (51662-1562-1) 2 ml2021-07-180000-00-00NoNoCurrent