Home NDC 50242-090 ZELBORAF
Product NDC 50242-090
11-digit product format 502420090
Labeler code 50242
Product ID 50242-090_77f36fc9-7ae6-425a-9dff-79ab4476c864
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vemurafenib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Genentech, Inc.
Application NDA202429
Marketing category NDA
Marketing start 2011-08-17
Substance VEMURAFENIB
Active strength 240 mg/1
Pharmacologic classes Cytochrome P450 1A2 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], Protein Kinase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N202429-001 ZELBORAF VEMURAFENIB 240MG TABLET / ORAL RLD, RS 2011-08-17
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202429-001 8143271 2026-06-21 Drug substance, Drug product 2012-04-20 N202429-001 8470818 2026-08-02 U-1418 2013-07-23 N202429-001 8470818 2026-08-02 U-2164 2013-07-23 N202429-001 7504509 2026-10-22 Drug substance, Drug product N202429-001 7863288 2029-06-20 Drug substance, Drug product N202429-001 8741920 2030-07-27 Drug substance, Drug product 2014-09-03 N202429-001 9447089 2032-06-06 Drug product 2016-10-18
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.
Product history page 1 of 2 · 41 observed 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 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202429-001 ZELBORAF 240MG TABLET / ORAL RLD, RS 2011-08-17 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 8 · 287 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 N202429-001 8143271 2026-06-21 Drug substance, Drug product 2012-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202429-001 8470818 2026-08-02 U-2164 2013-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202429-001 8470818 2026-08-02 U-1418 2013-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202429-001 7504509 2026-10-22 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202429-001 7863288 2029-06-20 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202429-001 8741920 2030-07-27 Drug substance, Drug product 2014-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202429-001 9447089 2032-06-06 Drug product 2016-10-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202429-001 8143271 2026-06-21 Drug substance, Drug product 2012-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202429-001 8470818 2026-08-02 U-2164 2013-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202429-001 8470818 2026-08-02 U-1418 2013-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202429-001 7504509 2026-10-22 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202429-001 7863288 2029-06-20 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202429-001 8741920 2030-07-27 Drug substance, Drug product 2014-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202429-001 9447089 2032-06-06 Drug product 2016-10-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202429-001 8143271 2026-06-21 Drug substance, Drug product 2012-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202429-001 8470818 2026-08-02 U-2164 2013-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202429-001 8470818 2026-08-02 U-1418 2013-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202429-001 7504509 2026-10-22 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202429-001 7863288 2029-06-20 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202429-001 8741920 2030-07-27 Drug substance, Drug product 2014-09-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202429-001 9447089 2032-06-06 Drug product 2016-10-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202429-001 8143271 2026-06-21 Drug substance, Drug product 2012-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202429-001 8470818 2026-08-02 U-2164 2013-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202429-001 8470818 2026-08-02 U-1418 2013-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202429-001 7504509 2026-10-22 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202429-001 7863288 2029-06-20 Drug substance, Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202429-001 8741920 2030-07-27 Drug substance, Drug product 2014-09-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202429-001 9447089 2032-06-06 Drug product 2016-10-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202429-001 8143271 2026-06-21 Drug substance, Drug product 2012-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202429-001 8470818 2026-08-02 U-2164 2013-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202429-001 8470818 2026-08-02 U-1418 2013-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202429-001 7504509 2026-10-22 Drug substance, Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202429-001 7863288 2029-06-20 Drug substance, Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202429-001 8741920 2030-07-27 Drug substance, Drug product 2014-09-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202429-001 9447089 2032-06-06 Drug product 2016-10-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202429-001 8143271 2026-06-21 Drug substance, Drug product 2012-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202429-001 8470818 2026-08-02 U-2164 2013-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202429-001 8470818 2026-08-02 U-1418 2013-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202429-001 7504509 2026-10-22 Drug substance, Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202429-001 7863288 2029-06-20 Drug substance, Drug product 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 45 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ZELBORAF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VEMURAFENIB 240 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 207SMY3FQT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1147223 Internal RxNorm lookup 1147228 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 50242-090-02 ZELBORAF 112 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 112 28 50242-090-02 ZELBORAF 1 in 1 CARTON TABLET, FILM COATED 1 28
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Vemurafenib ACTIVE INGREDIENT 207SMY3FQT ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.] 12 Vemurafenib ACTIVE MOIETY 207SMY3FQT ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.] 12 Croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.] 12 Ferric oxide red INACTIVE INGREDIENT 1K09F3G675 ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.] 12 Hydroxypropyl cellulose (Type H) INACTIVE INGREDIENT RFW2ET671P ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.] 12 Hypromellose acetate succinate 06081224 (3 MM2/S) INACTIVE INGREDIENT 6N003M473W ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.] 12 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.] 12 Polyethylene glycol 3350 INACTIVE INGREDIENT G2M7P15E5P ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.] 12 Polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.] 12 Silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.] 12 Talc INACTIVE INGREDIENT 7SEV7J4R1U ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.] 12 Titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50242-090 ZELBORAF (VEMURAFENIB) TABLET, FILM COATED [GENENTECH, INC.] 26 Current NDC, Legacy NDC, 2 package rows 20241123_38eea320-7e0c-485a-bc30-98c3c45e2763.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 Marketing end Sample Exclude flag Status 50242-090-02 50242009002 1 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) / 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2015-09-08 0000-00-00 No No Current 50242-090-86 50242009086 1 BOTTLE, PLASTIC in 1 CARTON (50242-090-86) > 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2014-04-10 0000-00-00 Yes No Current