FDA.reportPublic FDA data

Sotradecol

Product NDC
50090-4525
Requested package NDC
50090-4525-0
11-digit product format
500904525
Labeler code
50090
Product ID
50090-4525_3305d92f-0d6f-454c-81ea-bbad295b513b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tetradecyl hydrogen sulfate (ester)
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA040541
Marketing category
ANDA
Marketing start
2013-04-29
Marketing end
0000-00-00
Substance
TETRADECYL HYDROGEN SULFATE (ESTER)
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-452550090-4525-0IInactivated by FDA2026-07-31

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
(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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4525-02023-01-30C16284748780-1f386c649-f144-0266-e053-dadaa90a7c1aSOTRADECOL ® (Sodium Tetradecyl Sulfate Injection)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4525-0Sotradecol2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4525-0ML - Milliliter50090-4525a1d4d409-01a2-40db-85c9-6b4b87c50f0012022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4525SOTRADECOL (TETRADECYL HYDROGEN SULFATE (ESTER)) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20191228_23b7b990-2ecc-4b3a-8233-03c3b2584800.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
50090-4525-0500904525002 mL in 1 VIAL, MULTI-DOSE (50090-4525-0) 2 ml2019-09-160000-00-00NoNoCurrent