FDA.reportPublic FDA data

EVRYSDI

Product NDC
50242-202
11-digit product format
502420202
Labeler code
50242
Product ID
50242-202_a0597961-b4b9-47ec-961a-919fa9ffba95
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 1.

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
2026-02-19 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#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
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…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N219285-001121227892041-04-15Drug substance, Drug product2025-03-05fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219285-00195869552033-02-08Drug substance, Drug product2025-03-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219285-00199697542035-05-11U-1943Drug substance, Drug product2025-03-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219285-001118276462036-01-25U-19432025-03-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219285-001123502732038-10-01U-19432025-07-31a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219285-001115344442038-10-04U-19432025-03-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219285-001121227892041-04-15Drug substance, Drug product2025-03-05a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
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…

Additional Listing Data#

Finished product
Yes
Brand name base
EVRYSDI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISDIPLAM5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
76RS4S2ET1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2390940Internal RxNorm lookup
2390946Internal RxNorm lookup
2705365Internal RxNorm lookup
2705369Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eceb9a99-7191-4be5-87c3-0102707cf98eAvailable on FDA.report

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

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVRYSDIRISDIPLAMGenentech, Inc.eceb9a99-7191-4be5-87c3-0102707cf98e2026-02-19Adverse reactionsExact identifier
application applno (NDA): 219285
application number: NDA219285
ndc (product): 50242-202

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