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Sodium Tetradecyl Sulfate 30 mg/mL Injection, Solution — NDC 24201-0201-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sodium Tetradecyl Sulfate 30 mg/mL Injection, Solution — NDC 24201-201-05 (Billing 24201-0201-05)

by Hikma Pharmaceuticals USA Inc. · 5 VIAL, GLASS in 1 CARTON / 2 mL in 1 VIAL, GLASS

This is a package of Sodium Tetradecyl Sulfate 30 mg/mL Injection, Solution from Hikma Pharmaceuticals USA Inc., marketed since Dec 2019 and currently FDA-listed. It is this product's only package size.

NDC 24201-0201-05
🏷️ FDA NDC (as labeled) 24201-201-05 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 24201-201-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
24201 labeler · 201 product · 05 package
Package marketed since
Dec 9, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 2420120105 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 24201-201-05
Product NDC 24201-201
11-digit billing NDC 24201020105
NCPDP billing unit ML — per mL (volume)
RxCUI 204491
UNII Q1SUG5KBD6
Application # ANDA209937
SPL Set ID 997394e1-ec1f-4093-e053-2a95a90a0ea0
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-12-09
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance SODIUM TETRADECYL SULFATE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 99650010002010
GPI class Sodium Tetradecyl Sulfate
GCN Seq No 024180
GCN 37574
HICL code 003851
Ingredient (HICL) Sodium Tetradecyl Sulfate
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A8
Therapeutic class — intermediate (HIC2) Drugs Acting On Veins And Lymphatics
HIC3 code A8O
Therapeutic class — specific (HIC3) Venosclerosing Agents
AHFS code 24:12.00.00
AHFS class Sclerosing Agents
FDB label name SODIUM TETRA SULF 3% 60MG/2ML
FDB brand name Sodium Tetradecyl Sulfate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 024180
  • GCN: 37574
  • GPI-14 (Medi-Span): 99650010002010
  • HICL (First Databank): 003851
  • AHFS class code: 24:12.00.00
  • RxCUI (RxNorm): 204491
Why two NDCs? The FDA registers this code as 24201-201-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 24201-0201-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Sclerosing agents for local injection class.

Drug family (ATC) Sclerosing agents for local injection
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name SODIUM TETRA SULF 3% 60MG/2ML Ingredient Sodium Tetradecyl Sulfate

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
24201-0201-05 You're viewing this Main listing 5 VIAL, GLASS in 1 CARTON / 2 mL in 1 VIAL, GLASS 2019-12-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Tetradecyl Sulfate 30 mg/mLthis 24201-0201-05 Hikma 5 vials — AP FDA listed —
Sotradecol 30 mg/mL 67457-0163-02 Mylan 5 vials — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Dec 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 0.02 mL / 1 mL UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 9 mg / 1 mL UNII 22ADO53M6F
    A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerHikma Pharmaceuticals USA Inc.
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA209937 (ANDA)
Labeler code24201
First marketedDec 2019
Product typeHuman Prescription Drug
Portfolio726 products on file

More NDCs from Hikma Pharmaceuticals USA Inc. labeler code 24201

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 43 words ▾

INDICATIONS AND USAGE Sodium tetradecyl sulfate injection is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. The benefit- to-risk ratio should be considered in selected patients who are great surgical risks.

⏱️ Dosage and Administration 94 words ▾

DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if precipitated or discolored. Sodium tetradecyl sulfate injection is for intravenous use only.

The strength of solution required depends on the size and degree of varicosity. In general, the 1% solution will be found most useful with the 3% solution preferred for larger varicosities. The dosage should be kept small, using 0.5 mL to 2 mL (preferably 1 mL maximum) for each injection, and the maximum single treatment should not exceed 10 mL.

⛔ Contraindications 76 words ▾

CONTRAINDICATIONS Sodium tetradecyl sulfate injection is contraindicated in previous hypersensitivity reactions to the drug; in acute superficial thrombophlebitis; valvular or deep vein incompetence; huge superficial veins with wide open communications to deeper veins; phlebitis migrans; acute cellulitis; allergic conditions; acute infections; varicosities caused by abdominal and pelvic tumors unless the tumor has been removed; bedridden patients; such uncontrolled systemic diseases as diabetes, toxic hyperthyroidism, tuberculosis, asthma, neoplasm, sepsis, blood dyscrasias and acute respiratory or skin diseases.

⚠️ Warnings ~2 min read ▾

WARNINGS Sodium tetradecyl sulfate injection should only be administered by a healthcare professional experienced in venous anatomy and the diagnosis and treatment of conditions affecting the venous system and familiar with proper injection technique. Severe adverse local effects, including tissue necrosis, may occur following extravasation; therefore, extreme care in intravenous needle placement and using the minimal effective volume at each injection site are important. Emergency resuscitation equipment should be immediately available.

Allergic reactions, including fatal anaphylaxis, have been reported. As a precaution against anaphylactic shock, it is recommended that 0.5 mL of sodium tetradecyl sulfate injection be injected into a varicosity, followed by observation of the patient for several hours before administration of a second or larger dose. The possibility of an anaphylactic reaction should be kept in mind, and the physician should be prepared to treat it appropriately.

Because of the danger of thrombosis extension into the deep venous system, thorough preinjection evaluation for valvular competency should be carried out and slow injections with a small amount (not over 2 mL) of the preparation should be injected into the varicosity. Deep venous patency must be determined by noninvasive testing such as duplex ultrasound. Venous sclerotherapy should not be undertaken if tests such as Trendelenberg and Perthes, and angiography show significant valvular or deep venous incompetence.

The development of deep vein thrombosis and pulmonary embolism have been reported following sclerotherapy treatment of superficial varicosities. Patients should have post-treatment follow-up of sufficient duration to assess for the development of deep vein thrombosis. Embolism may occur as long as four weeks after injection of sodium tetradecyl sulfate.

Adequate post-treatment compression may decrease the incidence of deep vein thrombosis. Arterial Embolism Stroke, transient ischemic attack, myocardial infarction, and impaired cardiac function have been reported in close temporal relationship with STS administration. These events may be caused by air embolism when using the product foamed with room air (high nitrogen concentration) or thromboembolism.

The safety and efficacy of STS foamed with room air has not been established and its use should be avoided.

🤒 Adverse Reactions 200 words ▾

ADVERSE REACTIONS Local reactions consisting of pain, urticaria or ulceration may occur at the site of injection. A permanent discoloration may remain along the path of the sclerosed vein segment. Sloughing and necrosis of tissue may occur following extravasation of the drug.

(See WARNINGS section.) Allergic reactions such as hives, asthma, hay fever and anaphylactic shock have been reported. Mild systemic reactions that have been reported include headache, nausea and vomiting. (See WARNINGS section.) At least six deaths have been reported with the use of sodium tetradecyl sulfate injection.

Four cases of anaphylactic shock leading to death have been reported in patients who received sodium tetradecyl sulfate injection. One of these four patients reported a history of asthma, a contraindication to the administration of sodium tetradecyl sulfate injection. (See WARNINGS section.) One death has been reported in a patient who received sodium tetradecyl sulfate injection and who had been receiving an antiovulatory agent.

Another death (fatal pulmonary embolism) has been reported in a 36-year-old female treated with sodium tetradecyl acetate and who was not taking oral contraceptives. Cerebrovascular accident, myocardial infarction To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800 FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 57 words ▾

DRUG INTERACTIONS No well-controlled studies have been performed on patients taking antiovulatory agents. The physician must use judgment and evaluate any patient taking antiovulatory drugs prior to initiating treatment with sodium tetradecyl sulfate injection. (See ADVERSE REACTIONS section.) Heparin should not be included in the same syringe as sodium tetradecyl sulfate injection, since the two are incompatible.

🤰 Pregnancy 61 words ▾

PREGNANCY Teratogenic Effects Animal reproduction studies have not been conducted with sodium tetradecyl sulfate injection. It is also not known whether sodium tetradecyl sulfate injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium tetradecyl sulfate injection should be given to a pregnant woman only if clearly needed and the benefits outweigh the risks.

🧒 Pediatric Use 12 words ▾

PEDIATRIC USE Safety and effectiveness in pediatric patients have not been established.

🧬 Clinical Pharmacology 43 words ▾

CLINICAL PHARMACOLOGY Sodium tetradecyl sulfate injection is a sclerosing agent. Intravenous injection causes intima inflammation and thrombus formation. This usually occludes the injected vein. Subsequent formation of fibrous tissue results in partial or complete vein obliteration that may or may not be permanent.

📦 How Supplied / Storage and Handling 30 words ▾

HOW SUPPLIED Sodium tetradecyl sulfate injection, 3%, 60 mg/2 mL (30 mg/mL) is a sterile nonpyrogenic solution for intravenous use. NDC 24201-201-05 Carton containing 5 x 2 mL multiple-dose vials.

📦 Storage and Handling 14 words ▾

STORAGE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

📋 Description 97 words ▾

DESCRIPTION Sodium tetradecyl sulfate is an anionic surfactant which occurs as a white, waxy solid. The structural formula is as follows: C 14 H 29 NaSO 4 7-Ethyl-2-methyl-4-hendecanol sulfate sodium salt MW 316.44 Sodium tetradecyl sulfate injection is a sterile nonpyrogenic solution for intravenous use as a sclerosing agent. 3% 60 mg/2 mL (30 mg/mL): Each mL contains sodium tetradecyl sulfate 30 mg, benzyl alcohol 0.02 mL and dibasic sodium phosphate, anhydrous 9 mg in Water for Injection. pH 7.9; monobasic sodium phosphate and/or sodium hydroxide added, if needed, for pH adjustment.

Sodium Tetradecyl Sulfate Structural Formula

⚠️ Precautions 24 words ▾

PRECAUTIONS GENERAL Extreme caution must be exercised in the presence of underlying arterial disease such as marked peripheral arteriosclerosis or thromboangiitis obliterans (Buerger’s Disease).

🍼 Nursing Mothers 37 words ▾

NURSING MOTHERS It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sodium tetradecyl sulfate injection is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 53 words ▾

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY When tested in the L5178YTK +/- mouse lymphoma assay, sodium tetradecyl sulfate did not induce a dose-related increase in the frequency of thymidine kinase-deficient mutants and, therefore, was judged to be nonmutagenic in this system. However, no long-term animal carcinogenicity studies with sodium tetradecyl sulfate have been performed.

📄 Package Label / Principal Display Panel 71 words ▾

PRINCIPAL DISPLAY PANEL - 30 mg/mL Carton Label NDC 24201- 201 -01 2 mL Multiple-Dose Vial Sodium Tetradecyl Sulfate 3% Injection 60 mg/2 mL (30 mg/mL) FOR IV USE ONLY DO NOT USE IF PRECIPITATED Rx Only NDC 24201- 201 -05 5 x 2 mL Multiple-Dose Vial Sodium Tetradecyl Sulfate 3% Injection 60 mg/2 mL (30 mg/mL) FOR IV USE ONLY DO NOT USE IF PRECIPITATED Rx Only unit Label carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for SODIUM TETRADECYL SULFATE — the ingredient across all brands.

Top reported reactions

Air Embolism3
Deep Vein Thrombosis3
Disease Progression3
Drug Ineffective For Unapproved Indication3
Ischaemic Stroke3
Pain3
Acute Myocardial Infarction2

Age at onset

Neonate1
Child2
Adult1
Elderly2

Reporter sex

53 reports
Male · 29%
Female · 71%

Serious outcomes

Death4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4 1
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Hikma Pharmaceuticals USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hikma Pharmaceuticals USA Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 24201-0150-01 · Hikma 24201-0207-01 · Hikma →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.