Prescription drug · NDA
Lampit (Nifurtimox) NDC 50419-751
Nifurtimox 120 mg/1 · Tablet, Film coated · Oral · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-751-01 | 50419075101 | 1 BOTTLE in 1 CARTON (50419-751-01) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 1, 2020 |
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)
- Lampit
- Generic name (nonproprietary)
- nifurtimox
- Active ingredients
- Nifurtimox — 120 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213464
- Marketing start
- Listing expires
- Identifiers
- Product ID 50419-751_9b14492a-5ae2-4d0a-85c0-212636daf8cdSPL ID 9b14492a-5ae2-4d0a-85c0-212636daf8cdSPL set ID 90d09714-a8b1-4696-8ada-f99dc54d0721RxCUI 430512, 2395842, 2397991, 2397994UNII M84I3K7C2O
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
N450419075101followed by a unit qualifier and the quantityPackage 50419-0751-01. 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)
LAMPIT is indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi [see Clinical Studies ( 14 )]. LAMPIT is a nitrofuran antiprotozoal, indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis), caused by Trypanosoma cruzi . ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 50419-751
- What is NDC 50419-751?
- 50419-751 is the product NDC for Lampit (nifurtimox), Nifurtimox 120 mg/1 tablet, film coated, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lampit (Nifurtimox).
- What is the active ingredient?
- Nifurtimox.
- Who is the labeler?
- Bayer HealthCare Pharmaceuticals Inc., NDC labeler code 50419. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lampit?
- 1 other product NDC are listed under this name. See all Lampit NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lampit products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lampitnifurtimox | Nifurtimox 30 mg/1 | Tablet, Film coatedOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-750 | 50419-0750-01 |
Other NDCs under NDA 213464
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 |
|---|---|---|---|---|
| Lampitnifurtimox | Nifurtimox 30 mg/1 | Tablet, Film coatedOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-750 |