Home NDC 0078-1154 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217514-001 TAFINLAR DABRAFENIB MESYLATE EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217514-001 7994185 2030-01-20 Drug substance, Drug product 2023-05-04 N217514-001 8415345 2030-01-20 Drug substance, Drug product 2023-05-04 N217514-001 7994185*PED 2030-07-20 Pediatric extension N217514-001 8415345*PED 2030-07-20 Pediatric extension N217514-001 8703781 2030-10-15 U-3565 Drug substance, Drug product 2023-05-04 N217514-001 8703781*PED 2031-04-15 Pediatric extension N217514-001 11504333 2038-06-29 Drug product 2023-05-04 N217514-001 11504333*PED 2038-12-29 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217514-001 TAFINLAR EQ 10MG BASE TABLET, FOR SUSPENSION / ORAL RLD, RS 2023-03-16 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 186 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N217514-001 7994185 2030-01-20 Drug substance, Drug product 2023-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217514-001 8415345 2030-01-20 Drug substance, Drug product 2023-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217514-001 7994185*PED 2030-07-20 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217514-001 8415345*PED 2030-07-20 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217514-001 8703781 2030-10-15 U-3565 Drug substance, Drug product 2023-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217514-001 8703781*PED 2031-04-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217514-001 11504333 2038-06-29 Drug product 2023-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217514-001 11504333*PED 2038-12-29 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 8835443 2025-06-10 U-3565 2023-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 8835443*PED 2025-12-10 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 7994185 2030-01-20 Drug substance, Drug product 2023-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 8415345 2030-01-20 Drug substance, Drug product 2023-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 7994185*PED 2030-07-20 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 8415345*PED 2030-07-20 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 8703781 2030-10-15 U-3565 Drug substance, Drug product 2023-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 8703781*PED 2031-04-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 11504333 2038-06-29 Drug product 2023-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217514-001 11504333*PED 2038-12-29 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217514-001 8835443 2025-06-10 U-3565 2023-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 8835443*PED 2025-12-10 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 7994185 2030-01-20 Drug substance, Drug product 2023-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 8415345 2030-01-20 Drug substance, Drug product 2023-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 7994185*PED 2030-07-20 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 8415345*PED 2030-07-20 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 8703781 2030-10-15 U-3565 Drug substance, Drug product 2023-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 8703781*PED 2031-04-15 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 11504333 2038-06-29 Drug product 2023-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217514-001 11504333*PED 2038-12-29 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 8835443 2025-06-10 U-3565 2023-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 8835443*PED 2025-12-10 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 7994185 2030-01-20 Drug substance, Drug product 2023-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 8415345 2030-01-20 Drug substance, Drug product 2023-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 7994185*PED 2030-07-20 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 8415345*PED 2030-07-20 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 8703781 2030-10-15 U-3565 Drug substance, Drug product 2023-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 8703781*PED 2031-04-15 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 11504333 2038-06-29 Drug product 2023-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217514-001 11504333*PED 2038-12-29 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217514-001 8835443 2025-06-10 U-3565 2023-05-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217514-001 8835443*PED 2025-12-10 Pediatric extension b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 76 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tafinlar
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DABRAFENIB MESYLATE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B6DC89I63E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1424916 Internal RxNorm lookup 1424918 Internal RxNorm lookup 1425228 Internal RxNorm lookup 1425230 Internal RxNorm lookup 2632552 Internal RxNorm lookup 2632556 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-1154-21 Tafinlar 210 in 1 BOTTLE TABLET, FOR SUSPENSION 210 37
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-1154 TAFINLAR (DABRAFENIB) CAPSULE TAFINLAR (DABRAFENIB) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 35 Current NDC, 1 package rows 20250412_fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table 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 Current