Sotradecol

Product NDC
50090-4525
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-4525IInactivated by FDA2026-09-09
excluded packagepackage50090-452550090-4525-0IInactivated by FDA2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-4525-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4525-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4525-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4525-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4525-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4525-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4525-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4525-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4525-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4525-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4525-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4525-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4525-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4525-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4525-01332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-12caaa826d4ba7…
2026-08-18 06:07:402026-07A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONRS2004-11-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-12bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040541-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040541-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040541-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040541-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040541-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040541-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040541-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040541-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040541-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040541-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040541-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040541-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040541-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040541-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040541-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040541-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040541-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040541-002AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A040541-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040541-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040541-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A040541-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040541-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040541-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040541-002AP13f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040541-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040541-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040541-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040541-002AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040541-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040541-002AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040541-002AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040541-002AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040541-002AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040541-002AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040541-002AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040541-002AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040541-002AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040541-002AP1a50c72e98297…

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 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