Prescription drug · NDA
Tafinlar (Dabrafenib) NDC 0078-1154
Dabrafenib mesylate 10 mg/1 · Tablet, For suspension · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-1154-21 | 00078115421 | 210 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-1154-21)Marketed from Mar 16, 2023 |
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)
- Tafinlar
- Generic name (nonproprietary)
- dabrafenib
- Active ingredients
- Dabrafenib mesylate — 10 mg/1
- Dosage form
- Tablet, For suspension
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217514
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 2C8 Inducers (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Organic Anion Transporter 1 Inhibitors (Mechanism)Organic Anion Transporter 3 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0078-1154_6c546993-1f7f-409b-b108-60f22e9b948aSPL ID 6c546993-1f7f-409b-b108-60f22e9b948aSPL set ID fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdeaRxCUI 1424916, 1424918, 1425228, 1425230, 2632552, 2632556UNII B6DC89I63E
- 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
N400078115421followed by a unit qualifier and the quantityPackage 00078-1154-21. 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)
TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ( 1.1 , 2.1 ) TAFINLAR is indicated, in combination with trametinib , for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.2 , 2.1 ) the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. ( 1.3 , 2.1 ) the treatment of patients with metastatic non-small cell lung cancer (NSCLC) wit…
Excerpt only. Read the full label for complete information.
About NDC 0078-1154
- What is NDC 0078-1154?
- 0078-1154 is the product NDC for Tafinlar (dabrafenib), Dabrafenib mesylate 10 mg/1 tablet, for suspension, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tafinlar (Dabrafenib).
- What is the active ingredient?
- Dabrafenib mesylate.
- 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 Tafinlar?
- 2 other product NDCs are listed under this name. See all Tafinlar NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tafinlar products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tafinlardabrafenib | Dabrafenib mesylate 50 mg/1 | CapsuleOral | Novartis Pharmaceuticals Corporation | 0078-0682 | 00078-0682-66 |
| Tafinlardabrafenib | Dabrafenib mesylate 75 mg/1 | CapsuleOral | Novartis Pharmaceuticals Corporation | 0078-0681 | 00078-0681-66 |