FDA.reportPublic FDA data

Sodium Tetradecyl Sulfate

Product NDC
24201-201
11-digit product format
242010201
Labeler code
24201
Product ID
24201-201_5c279d1b-193e-46d3-a28c-43a0d3f14f96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Tetradecyl Sulfate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA209937
Marketing category
ANDA
Marketing start
2019-12-09
Substance
SODIUM TETRADECYL SULFATE
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209937-001SODIUM TETRADECYL SULFATESODIUM TETRADECYL SULFATE60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAP2019-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209937-001AP

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 22:54:322026-06A209937-001SODIUM TETRADECYL SULFATE60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAP2019-12-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209937-001AP1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Tetradecyl SulfateSODIUM TETRADECYL SULFATEHikma Pharmaceuticals USA Inc.997394e1-ec1f-4093-e053-2a95a90a0ea02024-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209937
application number: ANDA209937
ndc (product): 24201-201

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Tetradecyl Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM TETRADECYL SULFATE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q1SUG5KBD6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
997394e1-ec1f-4093-e053-2a95a90a0ea0Available 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
24201-201-01Sodium Tetradecyl Sulfate2 mL in 1 VIAL, GLASSINJECTION, SOLUTION25
24201-201-05Sodium Tetradecyl Sulfate5 in 1 CARTONINJECTION, SOLUTION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24201-201-01ML - Milliliter24201-201ac19e256-3171-4b49-a414-78a70a79f2ad12020-01-03
24201-201-05ML - Milliliter24201-201a2e6475d-946a-41b4-b6e1-12e7320379b812020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24201-201SODIUM TETRADECYL SULFATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20240628_997394e1-ec1f-4093-e053-2a95a90a0ea0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204491sodium tetradecyl sulfate 3 % Injectable SolutionPSN997394e1-ec1f-4093-e053-2a95a90a0ea05
204491sodium tetradecyl sulfate 30 MG/ML Injectable SolutionSCD997394e1-ec1f-4093-e053-2a95a90a0ea05
204491sodium tetradecyl sulfate 3 % Injectable SolutionSY997394e1-ec1f-4093-e053-2a95a90a0ea05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24201-201-01242010201012 mL in 1 VIAL, GLASS2 mlHistorical
24201-201-05242010201055 VIAL, GLASS in 1 CARTON (24201-201-05) / 2 mL in 1 VIAL, GLASS (24201-201-01) 2019-12-090000-00-00NoNoCurrent