FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Tafinlar
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DABRAFENIB MESYLATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB6DC89I63E
Rxcui1424916, 1424918, 1425228, 1425230, 2632552, 2632556

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a27869f-966c-ce67-0dae-71af2484d79aProduct name420231005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-1154-21Tafinlar210 in 1 BOTTLETABLET, FOR SUSPENSION21037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-1154-21EA - Each0078-1154bf12e209-8c61-4160-971a-f44f1983baac12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-1154TAFINLAR (DABRAFENIB) CAPSULE TAFINLAR (DABRAFENIB) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]35Current NDC, 1 package rows20250412_fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2632552dabrafenib 10 MG Tablet for Oral SuspensionPSNfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
1424916dabrafenib 50 MG Oral CapsulePSNfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
1424918dabrafenib 75 MG Oral CapsulePSNfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
2632556Tafinlar 10 MG Tablet for Oral SuspensionPSNfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
1425228Tafinlar 50 MG Oral CapsulePSNfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
1425230Tafinlar 75 MG Oral CapsulePSNfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
2632556dabrafenib 10 MG Tablet for Oral Suspension [Tafinlar]SBDfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
1425228dabrafenib 50 MG Oral Capsule [Tafinlar]SBDfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
1425230dabrafenib 75 MG Oral Capsule [Tafinlar]SBDfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
2632552dabrafenib 10 MG Tablet for Oral SuspensionSCDfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
1424916dabrafenib 50 MG Oral CapsuleSCDfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
1424918dabrafenib 75 MG Oral CapsuleSCDfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
1424916dabrafenib (as dabrafenib methylsulfate 59.25 MG) 50 MG Oral CapsuleSYfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
1424918dabrafenib (as dabrafenib methylsulfate 88.88 MG) 75 MG Oral CapsuleSYfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
2632552dabrafenib 10 MG (as dabrafenib mesylate 11.85 MG) Tablet for Oral SuspensionSYfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
2632556Tafinlar 10 MG Tablet for Oral SuspensionSYfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
1425228Tafinlar 50 MG (as dabrafenib mesylate 59.25 MG) Oral CapsuleSYfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
1425228Tafinlar 50 MG Oral CapsuleSYfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
1425230Tafinlar 75 MG (as dabrafenib mesylate 88.88 MG) Oral CapsuleSYfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37
1425230Tafinlar 75 MG Oral CapsuleSYfee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0078-1154-2100078115421210 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-1154-21) 2023-03-16NoNoCurrent