Prescription drug · NDA
iwilfin (eflornithine hydrochloride) NDC 78670-150
Eflornithine hydrochloride 250 mg/1 · Tablet · Oral · USWM, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78670-150-01 | 78670015001 | 1 BOTTLE in 1 CARTON (78670-150-01) / 100 TABLET in 1 BOTTLEMarketed from Jan 15, 2024 |
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)
- iwilfin
- Generic name (nonproprietary)
- eflornithine hydrochloride
- Active ingredients
- Eflornithine hydrochloride — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- USWM, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215500
- Marketing start
- Listing expires
- Other FDA classes
- Decarboxylase Inhibitors (Mechanism)
- Identifiers
- Product ID 78670-150_5b900700-64d3-4f68-834a-2a71f5216a46SPL ID 5b900700-64d3-4f68-834a-2a71f5216a46SPL set ID 6716d8cc-66e6-4cee-935c-ccb85ed984f5RxCUI 2673199, 2673205UNII 4NH22NDW9H
- Pharmacologic class
- Antiprotozoal; Decarboxylase Inhibitor
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
N478670015001followed by a unit qualifier and the quantityPackage 78670-0150-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
IWILFIN (eflornithine) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. IWILFIN is an ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. ( 1 )
Excerpt only. Read the full label for complete information.