Prescription drug · NDA
Tabrecta (Capmatinib) NDC 0078-0709
Capmatinib hydrochloride 150 mg/1 · Tablet, Film coated · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0709-56 | 00078070956 | 56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-56)Marketed from May 6, 2020 | |
| 0078-0709-94 | 00078070994 | 56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-94)Marketed from May 6, 2020 · Sample package |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Tabrecta
- Generic name (nonproprietary)
- capmatinib
- Active ingredients
- Capmatinib hydrochloride — 150 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213591
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 1A2 Inhibitors (Mechanism)Mesenchymal Epithelial Transition Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 1 Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 2 K Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 0078-0709_0df064bb-358d-4c21-8525-9b8b9a5845a1SPL ID 0df064bb-358d-4c21-8525-9b8b9a5845a1SPL set ID 455892c3-d144-4ba8-9ab4-79cabff9876dRxCUI 2362234, 2362240, 2362242, 2362244UNII C2A374O70X
- 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
N400078070956followed by a unit qualifier and the quantityPackage 00078-0709-56. 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)
TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
Excerpt only. Read the full label for complete information.
About NDC 0078-0709
- What is NDC 0078-0709?
- 0078-0709 is the product NDC for Tabrecta (capmatinib), Capmatinib hydrochloride 150 mg/1 tablet, film coated, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tabrecta (Capmatinib).
- What is the active ingredient?
- Capmatinib hydrochloride.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tabrecta?
- 1 other product NDC are listed under this name. See all Tabrecta NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tabrecta products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tabrectacapmatinib | Capmatinib hydrochloride 200 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0716 | 00078-0716-5600078-0716-94 |
Other NDCs under NDA 213591
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 |
|---|---|---|---|---|
| Tabrectacapmatinib | Capmatinib hydrochloride 200 mg/1 | Tablet, Film coatedOral | Novartis Pharmaceuticals Corporation | 0078-0716 |