Tafinlar
- Product NDC
- 0078-0681
- 11-digit product format
- 000780681
- Labeler code
- 0078
- Product ID
- 0078-0681_6c546993-1f7f-409b-b108-60f22e9b948a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dabrafenib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA202806
- Marketing category
- NDA
- Marketing start
- 2016-04-01
- Substance
- DABRAFENIB MESYLATE
- Active strength
- 75 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tafinlar
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DABRAFENIB MESYLATE | 75 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | B6DC89I63E |
| Rxcui | 1424916, 1424918, 1425228, 1425230, 2632552, 2632556 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3a27869f-966c-ce67-0dae-71af2484d79a | Product name | 4 | 20231005 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0078-0681-66 | Tafinlar | 120 in 1 BOTTLE | CAPSULE | 120 | 37 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0078-0681-66 | EA - Each | 0078-0681 | 2d99accc-a8dd-45a3-b8fe-257321317b3e | 1 | 2016-05-16 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0078-0681 | TAFINLAR (DABRAFENIB) CAPSULE TAFINLAR (DABRAFENIB) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 35 | Current NDC, Legacy NDC, 1 package rows | 20250412_fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2632552 | dabrafenib 10 MG Tablet for Oral Suspension | PSN | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 1424916 | dabrafenib 50 MG Oral Capsule | PSN | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 1424918 | dabrafenib 75 MG Oral Capsule | PSN | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 2632556 | Tafinlar 10 MG Tablet for Oral Suspension | PSN | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 1425228 | Tafinlar 50 MG Oral Capsule | PSN | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 1425230 | Tafinlar 75 MG Oral Capsule | PSN | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 2632556 | dabrafenib 10 MG Tablet for Oral Suspension [Tafinlar] | SBD | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 1425228 | dabrafenib 50 MG Oral Capsule [Tafinlar] | SBD | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 1425230 | dabrafenib 75 MG Oral Capsule [Tafinlar] | SBD | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 2632552 | dabrafenib 10 MG Tablet for Oral Suspension | SCD | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 1424916 | dabrafenib 50 MG Oral Capsule | SCD | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 1424918 | dabrafenib 75 MG Oral Capsule | SCD | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 1424916 | dabrafenib (as dabrafenib methylsulfate 59.25 MG) 50 MG Oral Capsule | SY | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 1424918 | dabrafenib (as dabrafenib methylsulfate 88.88 MG) 75 MG Oral Capsule | SY | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 2632552 | dabrafenib 10 MG (as dabrafenib mesylate 11.85 MG) Tablet for Oral Suspension | SY | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 2632556 | Tafinlar 10 MG Tablet for Oral Suspension | SY | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 1425228 | Tafinlar 50 MG (as dabrafenib mesylate 59.25 MG) Oral Capsule | SY | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 1425228 | Tafinlar 50 MG Oral Capsule | SY | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 1425230 | Tafinlar 75 MG (as dabrafenib mesylate 88.88 MG) Oral Capsule | SY | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
| 1425230 | Tafinlar 75 MG Oral Capsule | SY | fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea | 37 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0078-0681-66 | 00078068166 | 120 CAPSULE in 1 BOTTLE (0078-0681-66) | 120 capsule | 2016-04-01 | 0000-00-00 | No | No | Current |