Prescription drug · NDA
Impavido (Miltefosine) NDC 71863-135
Miltefosine 50 mg/1 · Capsule · Oral · Eton Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71863-135-28 | 71863013528 | 2 BLISTER PACK in 1 CARTON (71863-135-28) / 14 CAPSULE in 1 BLISTER PACKMarketed from Sep 26, 2026 |
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)
- Impavido
- Generic name (nonproprietary)
- miltefosine
- Active ingredients
- Miltefosine — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Eton Pharmaceuticals, Inc.NDC labeler code 71863
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204684
- Marketing start
- Listing expires
- Identifiers
- Product ID 71863-135_57c515c8-f4b0-b876-e063-6394a90af0ccSPL ID 57c515c8-f4b0-b876-e063-6394a90af0cc
- Pharmacologic class
- Antileishmanial
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N471863013528followed by a unit qualifier and the quantityPackage 71863-0135-28. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 71863-135
- What is NDC 71863-135?
- 71863-135 is the product NDC for Impavido (miltefosine), Miltefosine 50 mg/1 capsule, listed with the FDA by Eton Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Impavido (Miltefosine).
- What is the active ingredient?
- Miltefosine.
- Who is the labeler?
- Eton Pharmaceuticals, Inc., NDC labeler code 71863. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Impavido?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.