Prescription drug · NDA
Jideytro (zidesamtinib) NDC 85001-102
Zidesamtinib 100 mg/1 · Tablet, Film coated · Oral · Nuvalent, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85001-102-01 | 85001010201 | 1 BOTTLE in 1 CARTON (85001-102-01) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 22, 2026 |
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)
- Jideytro
- Generic name (nonproprietary)
- zidesamtinib
- Active ingredients
- Zidesamtinib — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Nuvalent, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 220185
- Marketing start
- Listing expires
- Identifiers
- Product ID 85001-102_6c672099-2978-474e-b783-973fe94efcfbSPL ID 6c672099-2978-474e-b783-973fe94efcfbSPL set ID 3760e421-b523-4d9b-e063-6394a90ab94bRxCUI 2748288, 2748294, 2748296, 2748298UNII MX5KQV5XHCUPC 0385001101018, 0385001102015
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
N485001010201followed by a unit qualifier and the quantityPackage 85001-0102-01. 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)
JIDEYTRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.1 )] . JIDEYTRO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor.( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 220185
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 |
|---|---|---|---|---|
| Jideytrozidesamtinib | Zidesamtinib 25 mg/1 | Tablet, Film coatedOral | Nuvalent, Inc. | 85001-101 |