Prescription drug · ANDA
Sotradecol (Tetradecyl hydrogen sulfate (ester)) NDC 67457-163
Tetradecyl hydrogen sulfate (Ester) 30 mg/mL · Injection, Solution · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-163-02 | 67457016302 | 5 VIAL, MULTI-DOSE in 1 CARTON (67457-163-02) / 2 mL in 1 VIAL, MULTI-DOSE (67457-163-00)Marketed from Apr 29, 2013 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Sotradecol
- Generic name (nonproprietary)
- tetradecyl hydrogen sulfate (ester)
- Active ingredients
- Tetradecyl hydrogen sulfate (Ester) — 30 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Mylan Institutional LLCNDC labeler code 67457
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040541
- Marketing start
- Listing expires
- Identifiers
- Product ID 67457-163_ddecdc4b-0bd4-4b20-a0ac-3c0fa542c14fSPL ID ddecdc4b-0bd4-4b20-a0ac-3c0fa542c14fSPL set ID f1756c28-dcd2-4b49-be62-07ca20682018RxCUI 204490, 204491, 543732, 543739UNII 6326W0DRHY
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N467457016302followed by a unit qualifier and the quantityPackage 67457-0163-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Sotradecol (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.
Excerpt only. Read the full label for complete information.
About NDC 67457-163
- What is NDC 67457-163?
- 67457-163 is the product NDC for Sotradecol (tetradecyl hydrogen sulfate (ester)), Tetradecyl hydrogen sulfate (Ester) 30 mg/mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sotradecol (Tetradecyl hydrogen sulfate (ester)).
- What is the active ingredient?
- Tetradecyl hydrogen sulfate (Ester).
- Who is the labeler?
- Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sotradecol?
- 1 other product NDC are listed under this name. See all Sotradecol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sotradecol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sotradecoltetradecyl hydrogen sulfate (ester) | Tetradecyl hydrogen sulfate (Ester) 10 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-162 | 67457-0162-02 |
Other NDCs under ANDA 040541
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| (Sotradecol) Sodium Tetradecyl Sulfate | Tetradecyl hydrogen sulfate (Ester) 30 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1563 |
| Sodium Tetradecyl Sulfate | Tetradecyl hydrogen sulfate (Ester) 10 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1562 |
| Sotradecoltetradecyl hydrogen sulfate (ester) | Tetradecyl hydrogen sulfate (Ester) 10 mg/mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-162 |