FDA.reportPublic FDA data

Sotradecol

Product NDC
67457-163
11-digit product format
674570163
Labeler code
67457
Product ID
67457-163_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
30 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040541-001SOTRADECOLSODIUM TETRADECYL SULFATE20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-12
A040541-002SOTRADECOLSODIUM TETRADECYL SULFATE60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040541-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-12a50c72e98297…
2026-08-01 22:54:322026-06A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040541-002AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM TETRADECYL SULFATESODIUM TETRADECYL SULFATEHF Acquisition Co LLC, DBA HealthFirstc76f4b3b-9f93-349f-e053-2995a90a2d572024-02-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040541
application number: ANDA040541
SotradecolTETRADECYL HYDROGEN SULFATE (ESTER)Mylan Institutional LLCf1756c28-dcd2-4b49-be62-07ca206820182021-08-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040541
application number: ANDA040541
ndc (product): 67457-163
(SOTRADECOL) SODIUM TETRADECYL SULFATE(SOTRADECOL) SODIUM TETRADECYL SULFATEHF Acquisition Co LLC, DBA HealthFirstc59db022-bda8-1732-e053-2a95a90a24f82021-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040541
application number: ANDA040541

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)30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6326W0DRHYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204490Internal RxNorm lookup
204491Internal RxNorm lookup
543732Internal RxNorm lookup
543739Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f1756c28-dcd2-4b49-be62-07ca20682018Available on FDA.report

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
67457-163-00Sotradecol2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION212
67457-163-02Sotradecol5 in 1 CARTONINJECTION, SOLUTION512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-163-00ML - Milliliter67457-163b89d1fba-b588-4a78-8651-0bcccf0b28de12017-03-06
67457-163-02ML - Milliliter67457-163ed02112b-10c0-4a6e-837d-066dc0cc760812012-07-24

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
67457-163SOTRADECOL (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
204491sodium tetradecyl sulfate 3 % Injectable SolutionPSNc59db022-bda8-1732-e053-2a95a90a24f81
204491sodium tetradecyl sulfate 3 % Injectable SolutionPSN6538eda0-92c4-4dde-b1b4-23de4a5b4c7e1
543739Sotradecol 3 % Injectable SolutionPSN6538eda0-92c4-4dde-b1b4-23de4a5b4c7e1
543739sodium tetradecyl sulfate 30 MG/ML Injectable Solution [Sotradecol]SBD6538eda0-92c4-4dde-b1b4-23de4a5b4c7e1
204491sodium tetradecyl sulfate 30 MG/ML Injectable SolutionSCDc59db022-bda8-1732-e053-2a95a90a24f81
204491sodium tetradecyl sulfate 30 MG/ML Injectable SolutionSCD6538eda0-92c4-4dde-b1b4-23de4a5b4c7e1
204491sodium tetradecyl sulfate 3 % Injectable SolutionSYc59db022-bda8-1732-e053-2a95a90a24f81
204491sodium tetradecyl sulfate 3 % Injectable SolutionSY6538eda0-92c4-4dde-b1b4-23de4a5b4c7e1
543739Sotradecol 3 % Injectable SolutionSY6538eda0-92c4-4dde-b1b4-23de4a5b4c7e1
543739Sotradecol 30 MG/ML Injectable SolutionSY6538eda0-92c4-4dde-b1b4-23de4a5b4c7e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-163-00674570163002 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
67457-163-02674570163025 VIAL, MULTI-DOSE in 1 CARTON (67457-163-02) / 2 mL in 1 VIAL, MULTI-DOSE (67457-163-00) 2013-04-290000-00-00NoNoCurrent