Home NDC 50242-140 ERIVEDGE
Product NDC 50242-140
11-digit product format 502420140
Labeler code 50242
Product ID 50242-140_d8b343ee-5767-4934-ad68-5164d4de5228
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vismodegib
Dosage form CAPSULE
Route ORAL
Labeler Genentech, Inc.
Application NDA203388
Marketing category NDA
Marketing start 2012-01-30
Substance VISMODEGIB
Active strength 150 mg/1
Pharmacologic classes Hedgehog Pathway Inhibitor [EPC], Smoothened Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 N203388-001 ERIVEDGE VISMODEGIB 150MG CAPSULE / ORAL RLD, RS 2012-01-30
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203388-001 7888364 2028-11-11 Drug substance, Drug product 2012-02-27 N203388-001 9278961 2028-12-15 U-1825 2016-03-25
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 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203388-001 ERIVEDGE 150MG CAPSULE / ORAL RLD, RS 2012-01-30 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 113 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 N203388-001 7888364 2028-11-11 Drug substance, Drug product 2012-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203388-001 9278961 2028-12-15 U-1825 2016-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203388-001 9790183 2025-09-02 U-3109 2021-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203388-001 7888364 2028-11-11 Drug substance, Drug product 2012-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203388-001 9278961 2028-12-15 U-1825 2016-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203388-001 9790183 2025-09-02 U-3109 2021-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203388-001 7888364 2028-11-11 Drug substance, Drug product 2012-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203388-001 9278961 2028-12-15 U-1825 2016-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203388-001 9790183 2025-09-02 U-3109 2021-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203388-001 7888364 2028-11-11 Drug substance, Drug product 2012-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203388-001 9278961 2028-12-15 U-1825 2016-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203388-001 9790183 2025-09-02 U-3109 2021-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203388-001 7888364 2028-11-11 Drug substance, Drug product 2012-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203388-001 9278961 2028-12-15 U-1825 2016-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203388-001 9790183 2025-09-02 U-3109 2021-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203388-001 7888364 2028-11-11 Drug substance, Drug product 2012-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203388-001 9278961 2028-12-15 U-1825 2016-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203388-001 9790183 2025-09-02 U-3109 2021-05-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203388-001 7888364 2028-11-11 Drug substance, Drug product 2012-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203388-001 9278961 2028-12-15 U-1825 2016-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203388-001 9790183 2025-09-02 U-3109 2021-05-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203388-001 7888364 2028-11-11 Drug substance, Drug product 2012-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203388-001 9278961 2028-12-15 U-1825 2016-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203388-001 9790183 2025-09-02 U-3109 2021-05-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203388-001 7888364 2028-11-11 Drug substance, Drug product 2012-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203388-001 9278961 2028-12-15 U-1825 2016-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203388-001 9790183 2025-09-02 U-3109 2021-05-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203388-001 7888364 2028-11-11 Drug substance, Drug product 2012-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203388-001 9278961 2028-12-15 U-1825 2016-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203388-001 9790183 2025-09-02 U-3109 2021-05-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203388-001 7888364 2028-11-11 Drug substance, Drug product 2012-02-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203388-001 9278961 2028-12-15 U-1825 2016-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203388-001 9790183 2025-09-02 U-3109 2021-05-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203388-001 7888364 2028-11-11 Drug substance, Drug product 2012-02-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203388-001 9278961 2028-12-15 U-1825 2016-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203388-001 9790183 2025-09-02 U-3109 2021-05-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203388-001 7888364 2028-11-11 Drug substance, Drug product 2012-02-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203388-001 9278961 2028-12-15 U-1825 2016-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203388-001 9790183 2025-09-02 U-3109 2021-05-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N203388-001 7888364 2028-11-11 Drug substance, Drug product 2012-02-27 8072bd15b7f6…
Additional Listing Data#
Finished product Yes
Brand name base ERIVEDGE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VISMODEGIB 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 25X868M3DS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1242992 Internal RxNorm lookup 1242998 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 50242-140-01 ERIVEDGE 28 in 1 BOTTLE, PLASTIC CAPSULE 28 15 50242-140-01 ERIVEDGE 1 in 1 CARTON CAPSULE 1 15 50242-140-86 ERIVEDGE 1 in 1 CARTON CAPSULE 1 15 50242-140-86 ERIVEDGE 28 in 1 BOTTLE, PLASTIC CAPSULE 28 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded vismodegib ACTIVE INGREDIENT 25X868M3DS ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] 4 vismodegib ACTIVE MOIETY 25X868M3DS ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] 4 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] 4 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] 4 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] 4 gelatin INACTIVE INGREDIENT 2G86QN327L ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] 4 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] 4 povidone K29/32 INACTIVE INGREDIENT 390RMW2PEQ ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] 4 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] 4 sodium starch glycolate type a potato INACTIVE INGREDIENT 5856J3G2A2 ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] 4 talc INACTIVE INGREDIENT 7SEV7J4R1U ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] 4 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50242-140 ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] 15 Current NDC, Legacy NDC, 4 package rows 20241210_eb368bb6-80e3-4df9-8a85-91df0a2ada6a.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 50242-140-01 50242014001 1 BOTTLE, PLASTIC in 1 CARTON (50242-140-01) / 28 CAPSULE in 1 BOTTLE, PLASTIC 2012-01-30 0000-00-00 No No Current 50242-140-86 50242014086 1 BOTTLE, PLASTIC in 1 CARTON (50242-140-86) / 28 CAPSULE in 1 BOTTLE, PLASTIC 2013-04-09 0000-00-00 Yes No Current