Prescription drug · ANDA
Praziquantel NDC 49884-231
Praziquantel 600 mg/1 · Tablet, Film coated · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-231-83 | 49884023183 | 6 TABLET, FILM COATED in 1 BOTTLE (49884-231-83)Marketed from Nov 27, 2017 |
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)
- Praziquantel
- Generic name (nonproprietary)
- praziquantel
- Active ingredients
- Praziquantel — 600 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 49884
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208820
- Marketing start
- Listing expires
- Identifiers
- Product ID 49884-231_7ad466fb-1ad5-4342-a1d1-f37c1782ca4aSPL ID 7ad466fb-1ad5-4342-a1d1-f37c1782ca4aSPL set ID 16f2b9c4-a260-4a31-bd52-e5945913246cRxCUI 198140UNII 6490C9U457UPC 0349884231835
- 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
N449884023183followed by a unit qualifier and the quantityPackage 49884-0231-83. 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)
Praziquantel tablets are 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) Praziquantel tablets are 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 ,…
Excerpt only. Read the full label for complete information.
About NDC 49884-231
- What is NDC 49884-231?
- 49884-231 is the product NDC for Praziquantel, Praziquantel 600 mg/1 tablet, film coated, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Praziquantel.
- What is the active ingredient?
- Praziquantel.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 49884. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Praziquantel?
- 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.