Tafinlar
- Product NDC
- 0078-1154
- 11-digit product format
- 000781154
- Labeler code
- 0078
- Product ID
- 0078-1154_6c546993-1f7f-409b-b108-60f22e9b948a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dabrafenib
- Dosage form
- TABLET, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA217514
- Marketing category
- NDA
- Marketing start
- 2023-03-16
- Substance
- DABRAFENIB MESYLATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Kinase Inhibitor [EPC], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Protein Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| B6DC89I63E | DABRAFENIB MESYLATE | 1195768-06-9 | DABRAFENIB MESYLATE |
| QGP4HA4G1B | DABRAFENIB | 1195765-45-7 | dabrafenib |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0078-1154-21 | 00078115421 | 210 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-1154-21) | 2023-03-16 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Tafinlar | Novartis Pharmaceuticals Corporation | 2026-05-20 | HUMAN PRESCRIPTION DRUG LABEL | 37 |