Prescription drug · NDA
Cometriq (Cabozantinib) NDC 42388-013
Cabozantinib s-malate 20 mg/1 · Capsule · Oral · Exelixis, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42388-013-14 | 4238800131442388001314 | 4 BLISTER PACK in 1 CARTON (42388-013-14) / 21 CAPSULE in 1 BLISTER PACKMarketed from Nov 29, 2012 |
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)
- Cometriq
- Generic name (nonproprietary)
- cabozantinib
- Active ingredients
- Cabozantinib s-malate — 20 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Exelixis, Inc.NDC labeler code 42388
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203756
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 42388-013_03fee098-20c7-4a04-81a7-06fb7d8b1470SPL ID 03fee098-20c7-4a04-81a7-06fb7d8b1470SPL set ID 1a0c3bea-c87b-4d25-bb44-5f0174da6b34RxCUI 1363273, 1363279, 1363281, 1363284, 1363312, 1363408, 1363409, 1363410, 1364580, 1364581UNII 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
N442388001314followed by a unit qualifier and the quantityPackage 42388-0013-14. 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)
COMETRIQ is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). COMETRIQ is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 42388-013
- What is NDC 42388-013?
- 42388-013 is the product NDC for Cometriq (cabozantinib), Cabozantinib s-malate 20 mg/1 capsule, listed with the FDA by Exelixis, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cometriq (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 Cometriq?
- 2 other product NDCs are listed under this name. See all Cometriq NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cometriq products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cometriqcabozantinib | — | Kit | Exelixis, Inc. | 42388-011 | 42388-0011-14 |
| Cometriqcabozantinib | — | Kit | Exelixis, Inc. | 42388-012 | 42388-0012-14 |
Other NDCs under NDA 203756
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 |
|---|---|---|---|---|
| Cometriqcabozantinib | — | Kit | Exelixis, Inc. | 42388-011 |
| Cometriqcabozantinib | — | Kit | Exelixis, Inc. | 42388-012 |