FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISDIPLAM.75 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76RS4S2ET1
Rxcui2390940, 2390946, 2705365, 2705369

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
50242-175-07EVRYSDI1 in 1 CARTONPOWDER, FOR SOLUTION126
50242-175-07EVRYSDI80 mL in 1 BOTTLE, GLASSPOWDER, FOR SOLUTION8026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-175-07ML - Milliliter50242-1759e8800e9-aab6-4bd6-99cf-eaac593c293e12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-175EVRYSDI (RISDIPLAM) POWDER, FOR SOLUTION EVRYSDI (RISDIPLAM) TABLET [GENENTECH, INC.]20Current NDC, Legacy 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 startMarketing endSampleExclude flagStatus
50242-175-07502420175071 BOTTLE, GLASS in 1 CARTON (50242-175-07) / 80 mL in 1 BOTTLE, GLASS2020-08-070000-00-00NoNoCurrent