Home NDC 50242-175 EVRYSDI
Product NDC 50242-175
11-digit product format 502420175
Labeler code 50242
Product ID 50242-175_a0597961-b4b9-47ec-961a-919fa9ffba95
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risdiplam
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Genentech, Inc.
Application NDA213535
Marketing category NDA
Marketing start 2020-08-07
Substance RISDIPLAM
Active strength .75 mg/mL
Pharmacologic classes Increased Protein Synthesis [PE], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA], Survival of Motor Neuron 2 Splicing Modifier [EPC], Survival of Motor Neuron 2 Splicing Modifiers [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 N213535-001 EVRYSDI RISDIPLAM 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07
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 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 N213535-001 9969754 2035-05-11 U-1943 Drug substance, Drug product 2020-09-03 N213535-001 11827646 2036-01-25 U-1943 2023-12-14 N213535-001 11938136 2036-11-08 Drug product 2024-04-17 N213535-001 12350273 2038-10-01 U-1943 2025-07-31 N213535-001 11534444 2038-10-04 U-1943 2023-01-25 N213535-001 12122789 2041-04-15 Drug substance, Drug product 2024-11-12
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213535-001 M-270 2026-10-03 N213535-001 ODE-334 2027-08-07 N213535-001 ODE-400 2029-05-27
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 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 141 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 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213535-001 9969754 2035-05-11 U-1943 Drug substance, Drug product 2020-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213535-001 11827646 2036-01-25 U-1943 2023-12-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213535-001 11938136 2036-11-08 Drug product 2024-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213535-001 12350273 2038-10-01 U-1943 2025-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213535-001 11534444 2038-10-04 U-1943 2023-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213535-001 12122789 2041-04-15 Drug substance, Drug product 2024-11-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213535-001 9969754 2035-05-11 U-1943 Drug substance, Drug product 2020-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213535-001 11827646 2036-01-25 U-1943 2023-12-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213535-001 11938136 2036-11-08 Drug product 2024-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213535-001 12350273 2038-10-01 U-1943 2025-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213535-001 11534444 2038-10-04 U-1943 2023-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213535-001 12122789 2041-04-15 Drug substance, Drug product 2024-11-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213535-001 9969754 2035-05-11 U-1943 Drug substance, Drug product 2020-09-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213535-001 11827646 2036-01-25 U-1943 2023-12-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213535-001 11938136 2036-11-08 Drug product 2024-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213535-001 12350273 2038-10-01 U-1943 2025-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213535-001 11534444 2038-10-04 U-1943 2023-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213535-001 12122789 2041-04-15 Drug substance, Drug product 2024-11-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213535-001 9969754 2035-05-11 U-1943 Drug substance, Drug product 2020-09-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213535-001 11827646 2036-01-25 U-1943 2023-12-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213535-001 11938136 2036-11-08 Drug product 2024-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213535-001 11534444 2038-10-04 U-1943 2023-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213535-001 12122789 2041-04-15 Drug substance, Drug product 2024-11-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213535-001 9969754 2035-05-11 U-1943 Drug substance, Drug product 2020-09-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213535-001 11827646 2036-01-25 U-1943 2023-12-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213535-001 11938136 2036-11-08 Drug product 2024-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213535-001 11534444 2038-10-04 U-1943 2023-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213535-001 12122789 2041-04-15 Drug substance, Drug product 2024-11-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213535-001 9969754 2035-05-11 U-1943 Drug substance, Drug product 2020-09-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213535-001 11827646 2036-01-25 U-1943 2023-12-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213535-001 11938136 2036-11-08 Drug product 2024-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213535-001 11534444 2038-10-04 U-1943 2023-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213535-001 12122789 2041-04-15 Drug substance, Drug product 2024-11-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 2680178bc6a6…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 136 observed states.
Additional Listing Data#
Finished product Yes
Brand name base EVRYSDI
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RISDIPLAM .75 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 76RS4S2ET1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2390940 Internal RxNorm lookup 2390946 Internal RxNorm lookup 2705365 Internal RxNorm lookup 2705369 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 50242-175-07 EVRYSDI 1 in 1 CARTON POWDER, FOR SOLUTION 1 26 50242-175-07 EVRYSDI 80 mL in 1 BOTTLE, GLASS POWDER, FOR SOLUTION 80 26
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50242-175 EVRYSDI (RISDIPLAM) POWDER, FOR SOLUTION EVRYSDI (RISDIPLAM) TABLET [GENENTECH, INC.] 20 Current NDC, Legacy NDC, 2 package rows 20250322_eceb9a99-7191-4be5-87c3-0102707cf98e.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 50242-175-07 50242017507 1 BOTTLE, GLASS in 1 CARTON (50242-175-07) / 80 mL in 1 BOTTLE, GLASS 2020-08-07 0000-00-00 No No Current