Home NDC 50242-175 EVRYSDI
Product NDC 50242-175
11-digit product format 502420175
Labeler code 50242
Product ID 50242-175_db0ced2d-1b1a-4b2e-ba6a-5e3cbe0226ed
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 43 .
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 2026-09-14 22:38:34 2026-08 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213535-001 EVRYSDI 0.75MG/ML FOR SOLUTION / ORAL RLD, RS 2020-08-07 caaa826d4ba7…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 · 155 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213535-001 9969754 2035-05-11 U-1943 Drug substance, Drug product 2020-09-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213535-001 11827646 2036-01-25 U-1943 2023-12-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213535-001 11938136 2036-11-08 Drug product 2024-04-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213535-001 12350273 2038-10-01 U-1943 2025-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213535-001 11534444 2038-10-04 U-1943 2023-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213535-001 12122789 2041-04-15 Drug substance, Drug product 2024-11-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213535-001 9586955 2033-02-08 Drug substance, Drug product 2020-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213535-001 9969754 2035-05-11 U-1943 Drug substance, Drug product 2020-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213535-001 11827646 2036-01-25 U-1943 2023-12-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213535-001 11938136 2036-11-08 Drug product 2024-04-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213535-001 12350273 2038-10-01 U-1943 2025-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213535-001 11534444 2038-10-04 U-1943 2023-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213535-001 12122789 2041-04-15 Drug substance, Drug product 2024-11-12 caaa826d4ba7…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 142 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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
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