Prescription drug · NDA
Impavido (Miltefosine) NDC 69051-300
Miltefosine 50 mg/1 · Capsule · Oral · Profounda, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69051-300-01 | 6905103000169051030001 | 2 BLISTER PACK in 1 CARTON (69051-300-01) / 14 CAPSULE in 1 BLISTER PACKMarketed from Oct 29, 2015 |
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
- Profounda, Inc.NDC labeler code 69051
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204684
- Marketing start
- Marketing end
- Identifiers
- Product ID 69051-300_5d5727be-1d76-8f8f-e063-6294a90aa8beSPL ID 5d5727be-1d76-8f8f-e063-6294a90aa8be
- 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
N469051030001followed by a unit qualifier and the quantityPackage 69051-0300-01. 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 69051-300
- What is NDC 69051-300?
- 69051-300 is the product NDC for Impavido (miltefosine), Miltefosine 50 mg/1 capsule, listed with the FDA by Profounda, 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?
- Profounda, Inc., NDC labeler code 69051. 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?
- 1 other product NDC are listed under this name. See all Impavido NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Impavido products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Impavidomiltefosine | Miltefosine 50 mg/1 | CapsuleOral | Eton Pharmaceuticals, Inc. | 71863-135 | 71863-0135-28 |
Other NDCs under NDA 204684
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 |
|---|---|---|---|---|
| Impavidomiltefosine | Miltefosine 50 mg/1 | CapsuleOral | Eton Pharmaceuticals, Inc. | 71863-135 |