FDA.reportPublic FDA data

Sotradecol

Product NDC
67457-162
11-digit product format
674570162
Labeler code
67457
Product ID
67457-162_ddecdc4b-0bd4-4b20-a0ac-3c0fa542c14f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tetradecyl hydrogen sulfate (ester)
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA040541
Marketing category
ANDA
Marketing start
2013-04-29
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
Sotradecol
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, 204491, 543732, 543739

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-162-00Sotradecol2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION212
67457-162-02Sotradecol5 in 1 CARTONINJECTION, SOLUTION512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-162-00ML - Milliliter67457-16236031f5a-8eee-4f20-a527-7f4942e88ff112017-03-06
67457-162-02ML - Milliliter67457-162a1c93556-2466-4fc9-92fe-15f4e074681c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRADECYL HYDROGEN SULFATE (ESTER)ACTIVE INGREDIENT6326W0DRHYSOTRADECOL (TETRADECYL HYDROGEN SULFATE (ESTER)) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6
TETRADECYL HYDROGEN SULFATE (ESTER)ACTIVE MOIETY6326W0DRHYSOTRADECOL (TETRADECYL HYDROGEN SULFATE (ESTER)) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHSOTRADECOL (TETRADECYL HYDROGEN SULFATE (ESTER)) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FSOTRADECOL (TETRADECYL HYDROGEN SULFATE (ESTER)) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6
WaterINACTIVE INGREDIENT059QF0KO0RSOTRADECOL (TETRADECYL HYDROGEN SULFATE (ESTER)) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-162SOTRADECOL (TETRADECYL HYDROGEN SULFATE (ESTER)) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]12Current NDC, Legacy NDC, 2 package rows20211130_f1756c28-dcd2-4b49-be62-07ca20682018.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204490sodium tetradecyl sulfate 1 % Injectable SolutionPSNf1756c28-dcd2-4b49-be62-07ca2068201812
204491sodium tetradecyl sulfate 3 % Injectable SolutionPSNf1756c28-dcd2-4b49-be62-07ca2068201812
543732Sotradecol 1 % Injectable SolutionPSNf1756c28-dcd2-4b49-be62-07ca2068201812
543739Sotradecol 3 % Injectable SolutionPSNf1756c28-dcd2-4b49-be62-07ca2068201812
543732sodium tetradecyl sulfate 10 MG/ML Injectable Solution [Sotradecol]SBDf1756c28-dcd2-4b49-be62-07ca2068201812
543739sodium tetradecyl sulfate 30 MG/ML Injectable Solution [Sotradecol]SBDf1756c28-dcd2-4b49-be62-07ca2068201812
204490sodium tetradecyl sulfate 10 MG/ML Injectable SolutionSCDf1756c28-dcd2-4b49-be62-07ca2068201812
204491sodium tetradecyl sulfate 30 MG/ML Injectable SolutionSCDf1756c28-dcd2-4b49-be62-07ca2068201812
204490sodium tetradecyl sulfate 1 % Injectable SolutionSYf1756c28-dcd2-4b49-be62-07ca2068201812
204491sodium tetradecyl sulfate 3 % Injectable SolutionSYf1756c28-dcd2-4b49-be62-07ca2068201812
543732Sotradecol 1 % Injectable SolutionSYf1756c28-dcd2-4b49-be62-07ca2068201812
543732Sotradecol 10 MG/ML Injectable SolutionSYf1756c28-dcd2-4b49-be62-07ca2068201812
543739Sotradecol 3 % Injectable SolutionSYf1756c28-dcd2-4b49-be62-07ca2068201812
543739Sotradecol 30 MG/ML Injectable SolutionSYf1756c28-dcd2-4b49-be62-07ca2068201812
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
204490sodium tetradecyl sulfate 1 % Injectable SolutionPSN23b7b990-2ecc-4b3a-8233-03c3b25848001
543732Sotradecol 1 % Injectable SolutionPSN23b7b990-2ecc-4b3a-8233-03c3b25848001
543732sodium tetradecyl sulfate 10 MG/ML Injectable Solution [Sotradecol]SBD23b7b990-2ecc-4b3a-8233-03c3b25848001
204490sodium tetradecyl sulfate 10 MG/ML Injectable SolutionSCD23b7b990-2ecc-4b3a-8233-03c3b25848001
204490sodium tetradecyl sulfate 1 % Injectable SolutionSY23b7b990-2ecc-4b3a-8233-03c3b25848001
543732Sotradecol 1 % Injectable SolutionSY23b7b990-2ecc-4b3a-8233-03c3b25848001
543732Sotradecol 10 MG/ML Injectable SolutionSY23b7b990-2ecc-4b3a-8233-03c3b25848001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-162-00674570162002 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
67457-162-02674570162025 VIAL, MULTI-DOSE in 1 CARTON (67457-162-02) / 2 mL in 1 VIAL, MULTI-DOSE (67457-162-00) 2013-04-290000-00-00NoNoCurrent