Prescription drug · NDA
Lonsurf (Trifluridine and tipiracil) NDC 64842-1020
Trifluridine 20 mg/1; Tipiracil hydrochloride 8.19 mg/1 · Tablet, Film coated · Oral · Taiho Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64842-1020-1 | 6484210200164842102001 | 20 TABLET, FILM COATED in 1 BOTTLE (64842-1020-1)Marketed from Oct 7, 2015 | |
| 64842-1020-2 | 6484210200264842102002 | 40 TABLET, FILM COATED in 1 BOTTLE (64842-1020-2)Marketed from Nov 11, 2015 | |
| 64842-1020-3 | 6484210200364842102003 | 60 TABLET, FILM COATED in 1 BOTTLE (64842-1020-3)Marketed from Oct 21, 2015 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Lonsurf
- Generic name (nonproprietary)
- trifluridine and tipiracil
- Active ingredients
- Trifluridine — 20 mg/1Tipiracil hydrochloride — 8.19 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Taiho Pharmaceutical Co., Ltd.NDC labeler code 64842
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207981
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)Nucleoside Analog (EXT)Thymidine Phosphorylase Inhibitors (Mechanism)
- Identifiers
- Product ID 64842-1020_15b86e86-8940-44e3-921c-2e0b97180ea1SPL ID 15b86e86-8940-44e3-921c-2e0b97180ea1SPL set ID f5beed22-d71d-4c0d-8dca-2c7317d65d85RxCUI 1670311, 1670316, 1670322, 1670324UNII RMW9V5RW38, 4H59KLQ0A4
- Pharmacologic class
- Nucleoside Analog Antiviral; Nucleoside Metabolic Inhibitor; Thymidine Phosphorylase 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
N464842102001followed by a unit qualifier and the quantityPackage 64842-1020-01. 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)
LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. ( 1.1 ) metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted thera…
Excerpt only. Read the full label for complete information.
About NDC 64842-1020
- What is NDC 64842-1020?
- 64842-1020 is the product NDC for Lonsurf, Trifluridine 20 mg/1; Tipiracil hydrochloride 8.19 mg/1 tablet, film coated, listed with the FDA by Taiho Pharmaceutical Co., Ltd.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lonsurf (Trifluridine and tipiracil).
- What is the active ingredient?
- Trifluridine, Tipiracil hydrochloride.
- Who is the labeler?
- Taiho Pharmaceutical Co., Ltd., NDC labeler code 64842. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lonsurf?
- 1 other product NDC are listed under this name. See all Lonsurf NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lonsurf products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lonsurftrifluridine and tipiracil | Trifluridine 15 mg/1; Tipiracil hydrochloride 6.14 mg/1 | Tablet, Film coatedOral | Taiho Pharmaceutical Co., Ltd. | 64842-1025 | 64842-1025-0164842-1025-0264842-1025-03 |
Other NDCs under NDA 207981
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 |
|---|---|---|---|---|
| Lonsurftrifluridine and tipiracil | Trifluridine 15 mg/1; Tipiracil hydrochloride 6.14 mg/1 | Tablet, Film coatedOral | Taiho Pharmaceutical Co., Ltd. | 64842-1025 |