Prescription drug · NDA
Biltricide (Praziquantel) NDC 50419-747
Praziquantel 600 mg/1 · Tablet, Film coated · Oral · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-747-01 | 50419074701 | 6 TABLET, FILM COATED in 1 BOTTLE (50419-747-01)Marketed from Apr 21, 2011 |
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)
- Biltricide
- Generic name (nonproprietary)
- praziquantel
- Active ingredients
- Praziquantel — 600 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 018714
- Marketing start
- Listing expires
- Identifiers
- Product ID 50419-747_c9ab40f0-8a11-486f-be88-765af55b6484SPL ID c9ab40f0-8a11-486f-be88-765af55b6484SPL set ID 34ce1cdd-648e-4f1e-8512-bf3d4cc22eb9RxCUI 198140, 208975UNII 6490C9U457
- Pharmacologic class
- Anthelmintic
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
N450419074701followed by a unit qualifier and the quantityPackage 50419-0747-01. 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)
Biltricide is indicated in patients aged 1 year and older for the treatment of the following infections: • Schistosomiasis due to all species of schistosoma (for example, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma hematobium ), and • Clonorchiasis and Opisthorchiasis due to the liver flukes, Clonorchis sinensis/Opisthorchis viverrini (approval of this indication was based on studies in which the two species were not differentiated) Biltricide is an anthelmintic indicated in patients aged one year and older for the treatment of the following infections: • Schistosomiasis due to all species of schistosoma (for example , Schistosoma mekongi , Schistosoma jap…
Excerpt only. Read the full label for complete information.
About NDC 50419-747
- What is NDC 50419-747?
- 50419-747 is the product NDC for Biltricide (praziquantel), Praziquantel 600 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?
- Biltricide (Praziquantel).
- What is the active ingredient?
- Praziquantel.
- 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 Biltricide?
- 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.