Prescription drug · NDA
Cabometyx (Cabozantinib) NDC 42388-025
Cabozantinib s-malate 40 mg/1 · Tablet · Oral · Exelixis, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42388-025-26 | 4238800252642388002526 | 30 TABLET in 1 BOTTLE (42388-025-26)Marketed from Apr 25, 2016 | |
| 42388-025-37 | 4238800253742388002537 | 15 TABLET in 1 BOTTLE (42388-025-37)Marketed from Feb 27, 2019 · Sample package | |
| 42388-025-46 | 4238800254642388002546 | 1 BOTTLE in 1 CARTON (42388-025-46) / 30 TABLET in 1 BOTTLEMarketed from Jan 9, 2023 | |
| 42388-025-57 | 4238800255742388002557 | 1 BOTTLE in 1 CARTON (42388-025-57) / 15 TABLET in 1 BOTTLEMarketed from Jan 9, 2023 · Sample package |
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)
- Cabometyx
- Generic name (nonproprietary)
- cabozantinib
- Active ingredients
- Cabozantinib s-malate — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Exelixis, Inc.NDC labeler code 42388
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208692
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 42388-025_e8cdcbdc-d863-4d48-af3e-a8926b9ab017SPL ID e8cdcbdc-d863-4d48-af3e-a8926b9ab017SPL set ID 3850cce2-6137-42e5-a792-d318c4a4b3b5RxCUI 1790161, 1790167, 1790169, 1790171, 1790173, 1790175UNII DR7ST46X58
- 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
N442388002526followed by a unit qualifier and the quantityPackage 42388-0025-26. 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)
CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab ( 1.1 ) patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib ( 1.2 ) adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible ( 1.3 ) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or meta…
Excerpt only. Read the full label for complete information.
About NDC 42388-025
- What is NDC 42388-025?
- 42388-025 is the product NDC for Cabometyx (cabozantinib), Cabozantinib s-malate 40 mg/1 tablet, listed with the FDA by Exelixis, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cabometyx (Cabozantinib).
- What is the active ingredient?
- Cabozantinib s-malate.
- Who is the labeler?
- Exelixis, Inc., NDC labeler code 42388. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cabometyx?
- 2 other product NDCs are listed under this name. See all Cabometyx NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cabometyx products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cabometyxcabozantinib | Cabozantinib s-malate 60 mg/1 | TabletOral | Exelixis, Inc. | 42388-023 | 42388-0023-2642388-0023-3642388-0023-37+2 more |
| Cabometyxcabozantinib | Cabozantinib s-malate 20 mg/1 | TabletOral | Exelixis, Inc. | 42388-024 | 42388-0024-2642388-0024-3742388-0024-46+1 more |
Other NDCs under NDA 208692
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 |
|---|---|---|---|---|
| Cabometyxcabozantinib | Cabozantinib s-malate 60 mg/1 | TabletOral | Exelixis, Inc. | 42388-023 |
| Cabometyxcabozantinib | Cabozantinib s-malate 20 mg/1 | TabletOral | Exelixis, Inc. | 42388-024 |