Prescription drug · NDA
Lytgobi (Futibatinib) NDC 64842-0127
Futibatinib 16 mg/1 · Tablet · Oral · TAIHO PHARMACEUTICAL CO., LTD.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64842-0127-7 | 6484201270764842012707 | 1 BLISTER PACK in 1 CARTON (64842-0127-7) / 7 TABLET in 1 BLISTER PACKMarketed from Jun 1, 2026 |
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)
- Lytgobi
- Generic name (nonproprietary)
- futibatinib
- Active ingredients
- Futibatinib — 16 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TAIHO PHARMACEUTICAL CO., LTD.NDC labeler code 64842
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214801
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Fibroblast Growth Factor Receptor Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 64842-0127_87b2e0c4-3351-4a85-b721-19a0574daafaSPL ID 87b2e0c4-3351-4a85-b721-19a0574daafaSPL set ID 0b1332a1-0581-4707-9bf6-1eccfa39bef4RxCUI 2628195, 2628201, 2628203, 2628204, 2628205, 2628206, 2628207, 2628208, 2721464, 2721466, 2721467, 2721468, 2721469, 2721470UNII 4B93MGE4AL
- Pharmacologic class
- Kinase 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
N464842012707followed by a unit qualifier and the quantityPackage 64842-0127-07. 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)
LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [see Dosage and Administration (2.1) ] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). LYTGOBI is a kinase inhibitor indicated for the treatment of adult patients with previously treated, unresectable, locally adv…
Excerpt only. Read the full label for complete information.
About NDC 64842-0127
- What is NDC 64842-0127?
- 64842-0127 is the product NDC for Lytgobi (futibatinib), Futibatinib 16 mg/1 tablet, listed with the FDA by TAIHO PHARMACEUTICAL CO., LTD.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lytgobi (Futibatinib).
- What is the active ingredient?
- Futibatinib.
- 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 Lytgobi?
- 2 other product NDCs are listed under this name. See all Lytgobi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lytgobi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lytgobi | — | Kit | TAIHO PHARMACEUTICAL CO., LTD. | 64842-0128 | 64842-0128-08 |
| Lytgobifutibatinib | Futibatinib 4 mg/1 | TabletOral | TAIHO PHARMACEUTICAL CO., LTD. | 64842-0120 | 64842-0120-0464842-0120-0564842-0120-06 |
Other NDCs under NDA 214801
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 |
|---|---|---|---|---|
| Lytgobifutibatinib | Futibatinib 4 mg/1 | TabletOral | TAIHO PHARMACEUTICAL CO., LTD. | 64842-0120 |
| Lytgobi | — | Kit | TAIHO PHARMACEUTICAL CO., LTD. | 64842-0128 |