Prescription drug · NDA
Asclera (Polidocanol) NDC 67850-140
Polidocanol .005 g/mL · Injection, Solution · Intravenous · Methapharm, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67850-140-05 | 67850014005 | 2 mL in 1 AMPULE (67850-140-05)Marketed from Feb 1, 2022 |
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)
- Asclera
- Generic name (nonproprietary)
- polidocanol
- Active ingredients
- Polidocanol — .005 g/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Methapharm, IncNDC labeler code 67850
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021201
- Marketing start
- Listing expires
- Other FDA classes
- Sclerosing Activity (Mechanism)Vascular Sclerosing Activity (Physiologic effect)
- Identifiers
- Product ID 67850-140_f443bbaf-ef8e-4f9e-ba4c-6f87dc58a671SPL ID f443bbaf-ef8e-4f9e-ba4c-6f87dc58a671SPL set ID bb1f342b-5352-4059-a0b2-e60fd652fd28RxCUI 968173, 968177, 968181, 968183UNII 0AWH8BFG9AUPC 0367850141056, 0367850140059
- Pharmacologic class
- Sclerosing Agent
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
N467850014005followed by a unit qualifier and the quantityPackage 67850-0140-05. 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)
Asclera ® (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter. Asclera (polidocanol) is a sclerosing agent indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3mm in diameter. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 67850-140
- What is NDC 67850-140?
- 67850-140 is the product NDC for Asclera (polidocanol), Polidocanol .005 g/mL injection, solution, listed with the FDA by Methapharm, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Asclera (Polidocanol).
- What is the active ingredient?
- Polidocanol.
- Who is the labeler?
- Methapharm, Inc, NDC labeler code 67850. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Asclera?
- 1 other product NDC are listed under this name. See all Asclera NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Asclera products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Asclerapolidocanol | Polidocanol .01 g/mL | Injection, SolutionIntravenous | Methapharm, Inc | 67850-141 | 67850-0141-05 |
Other NDCs under NDA 021201
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 |
|---|---|---|---|---|
| Asclerapolidocanol | Polidocanol .01 g/mL | Injection, SolutionIntravenous | Methapharm, Inc | 67850-141 |