FDA.reportPublic FDA data

EVRYSDI

Product NDC
50242-202
11-digit product format
502420202
Labeler code
50242
Product ID
50242-202_db0ced2d-1b1a-4b2e-ba6a-5e3cbe0226ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risdiplam
Dosage form
TABLET
Route
ORAL
Labeler
Genentech, Inc.
Application
NDA219285
Marketing category
NDA
Marketing start
2025-02-11
Substance
RISDIPLAM
Active strength
5 mg/1
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 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219285-001EVRYSDIRISDIPLAM5MGTABLET / ORALRLD, RS2025-02-11

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219285-00195869552033-02-08Drug substance, Drug product2025-03-05
N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-05
N219285-001118276462036-01-25U-19432025-03-05
N219285-001123502732038-10-01U-19432025-07-31
N219285-001115344442038-10-04U-19432025-03-05
N219285-001121227892041-04-15Drug substance, Drug product2025-03-05

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219285-001M-2702026-10-03

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N219285-001EVRYSDI5MGTABLET / ORALRLD, RS2025-02-11c2088c7a36db…
2026-09-14 22:38:342026-08N219285-001EVRYSDI5MGTABLET / ORALRLD, RS2025-02-1184e616aacf4f…
2026-08-18 06:07:402026-07N219285-001EVRYSDI5MGTABLET / ORALRLD, RS2025-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219285-001EVRYSDI5MGTABLET / ORALRLD, RS2025-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-001EVRYSDI5MGTABLET / ORALRLD, RS2025-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N219285-001EVRYSDI5MGTABLET / ORALRLD, RS2025-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219285-001EVRYSDI5MGTABLET / ORALRLD, RS2025-02-11fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219285-001EVRYSDI5MGTABLET / ORALRLD, RS2025-02-11a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N219285-00195869552033-02-08Drug substance, Drug product2025-03-05c2088c7a36db…
2026-10-15 13:18:302026-09N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-05c2088c7a36db…
2026-10-15 13:18:302026-09N219285-001118276462036-01-25U-19432025-03-05c2088c7a36db…
2026-10-15 13:18:302026-09N219285-001123502732038-10-01U-19432025-07-31c2088c7a36db…
2026-10-15 13:18:302026-09N219285-001115344442038-10-04U-19432025-03-05c2088c7a36db…
2026-10-15 13:18:302026-09N219285-001121227892041-04-15Drug substance, Drug product2025-03-05c2088c7a36db…
2026-09-14 22:38:342026-08N219285-00195869552033-02-08Drug substance, Drug product2025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219285-001118276462036-01-25U-19432025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219285-001123502732038-10-01U-19432025-07-3184e616aacf4f…
2026-09-14 22:38:342026-08N219285-001115344442038-10-04U-19432025-03-0584e616aacf4f…
2026-09-14 22:38:342026-08N219285-001121227892041-04-15Drug substance, Drug product2025-03-0584e616aacf4f…
2026-08-18 06:07:402026-07N219285-00195869552033-02-08Drug substance, Drug product2025-03-05caaa826d4ba7…
2026-08-18 06:07:402026-07N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-05caaa826d4ba7…
2026-08-18 06:07:402026-07N219285-001118276462036-01-25U-19432025-03-05caaa826d4ba7…
2026-08-18 06:07:402026-07N219285-001123502732038-10-01U-19432025-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N219285-001115344442038-10-04U-19432025-03-05caaa826d4ba7…
2026-08-18 06:07:402026-07N219285-001121227892041-04-15Drug substance, Drug product2025-03-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219285-00195869552033-02-08Drug substance, Drug product2025-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219285-001118276462036-01-25U-19432025-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219285-001123502732038-10-01U-19432025-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219285-001115344442038-10-04U-19432025-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219285-001121227892041-04-15Drug substance, Drug product2025-03-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-00195869552033-02-08Drug substance, Drug product2025-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-001118276462036-01-25U-19432025-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-001123502732038-10-01U-19432025-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-001115344442038-10-04U-19432025-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-001121227892041-04-15Drug substance, Drug product2025-03-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N219285-00195869552033-02-08Drug substance, Drug product2025-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219285-001118276462036-01-25U-19432025-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219285-001123502732038-10-01U-19432025-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219285-001115344442038-10-04U-19432025-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219285-001121227892041-04-15Drug substance, Drug product2025-03-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219285-00195869552033-02-08Drug substance, Drug product2025-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219285-001118276462036-01-25U-19432025-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219285-001115344442038-10-04U-19432025-03-05fd3edfee7708…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09N219285-001M-2702026-10-03c2088c7a36db…
2026-09-14 22:38:342026-08N219285-001M-2702026-10-0384e616aacf4f…
2026-08-18 06:07:402026-07N219285-001M-2702026-10-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219285-001M-2702026-10-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-001NCE2025-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N219285-001M-2702026-10-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N219285-001NCE2025-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N219285-001M-2702026-10-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219285-001NCE2025-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219285-001M-2702026-10-03fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219285-001M-2702026-10-03a50c72e98297…

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
IngredientStrength
RISDIPLAM5 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
88910e1f-a340-42c9-b195-ca37c19443d4Product name220251120
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-202-01EVRYSDI1 in 1 CARTONTABLET126
50242-202-01EVRYSDI30 in 1 BOTTLE, PLASTICTABLET3026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-202-01EA - Each50242-202545d7db8-7d6f-4549-a330-cc36a011970912025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-202EVRYSDI (RISDIPLAM) POWDER, FOR SOLUTION EVRYSDI (RISDIPLAM) TABLET [GENENTECH, INC.]20Current NDC, 2 package rows20250322_eceb9a99-7191-4be5-87c3-0102707cf98e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2390946Evrysdi 0.75 MG/mL Oral SolutionPSNeceb9a99-7191-4be5-87c3-0102707cf98e26
2705369Evrysdi 5 MG Oral TabletPSNeceb9a99-7191-4be5-87c3-0102707cf98e26
2390940risdiplam 0.75 MG/mL Oral SolutionPSNeceb9a99-7191-4be5-87c3-0102707cf98e26
2705365risdiplam 5 MG Oral TabletPSNeceb9a99-7191-4be5-87c3-0102707cf98e26
2390946risdiplam 0.75 MG/ML Oral Solution [Evrysdi]SBDeceb9a99-7191-4be5-87c3-0102707cf98e26
2705369risdiplam 5 MG Oral Tablet [Evrysdi]SBDeceb9a99-7191-4be5-87c3-0102707cf98e26
2390940risdiplam 0.75 MG/ML Oral SolutionSCDeceb9a99-7191-4be5-87c3-0102707cf98e26
2705365risdiplam 5 MG Oral TabletSCDeceb9a99-7191-4be5-87c3-0102707cf98e26
2390946Evrysdi 0.75 MG/ML Oral SolutionSYeceb9a99-7191-4be5-87c3-0102707cf98e26
2705369Evrysdi 5 MG Oral TabletSYeceb9a99-7191-4be5-87c3-0102707cf98e26
2390946Evrysdi 60 MG per 80 ML Oral SolutionSYeceb9a99-7191-4be5-87c3-0102707cf98e26
2390940risdiplam 0.75 MG per ML Oral SolutionSYeceb9a99-7191-4be5-87c3-0102707cf98e26
2390940risdiplam 60 MG per 80 ML Oral SolutionSYeceb9a99-7191-4be5-87c3-0102707cf98e26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50242-202-01502420202011 BOTTLE, PLASTIC in 1 CARTON (50242-202-01) / 30 TABLET in 1 BOTTLE, PLASTIC2025-02-11NoNoCurrent