evrysdi

Generic: risdiplam

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name evrysdi
Generic Name risdiplam
Labeler genentech, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

risdiplam 5 mg/1

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-202
Product ID 50242-202_a0597961-b4b9-47ec-961a-919fa9ffba95
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219285
Listing Expiration 2027-12-31
Marketing Start 2025-02-11

Pharmacologic Class

Established (EPC)
survival of motor neuron 2 splicing modifier [epc]
Mechanism of Action
survival of motor neuron 2 splicing modifiers [moa] multidrug and toxin extrusion transporter 1 inhibitors [moa] multidrug and toxin extrusion transporter 2 k inhibitors [moa]
Physiologic Effect
increased protein synthesis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242202
Hyphenated Format 50242-202

Supplemental Identifiers

RxCUI
2390940 2390946 2705365 2705369
UNII
76RS4S2ET1
NUI
N0000194059 N0000194060 N0000009533 N0000191423 N0000193932

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name evrysdi (source: ndc)
Generic Name risdiplam (source: ndc)
Application Number NDA219285 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (50242-202-01) / 30 TABLET in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

50242-202-01 1 BOTTLE, PLASTIC in 1 CARTON (50242-202-01) / 30 TABLET in 1 BOTTLE, PLASTIC

Ingredients (1)

risdiplam (5 mg/1)

Linked Drug Pages (1)

EVRYSDI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a0597961-b4b9-47ec-961a-919fa9ffba95", "openfda": {"nui": ["N0000194059", "N0000194060", "N0000009533", "N0000191423", "N0000193932"], "unii": ["76RS4S2ET1"], "rxcui": ["2390940", "2390946", "2705365", "2705369"], "spl_set_id": ["eceb9a99-7191-4be5-87c3-0102707cf98e"], "pharm_class_pe": ["Increased Protein Synthesis [PE]"], "pharm_class_epc": ["Survival of Motor Neuron 2 Splicing Modifier [EPC]"], "pharm_class_moa": ["Survival of Motor Neuron 2 Splicing Modifiers [MoA]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]", "Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA]"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50242-202-01)  / 30 TABLET in 1 BOTTLE, PLASTIC", "package_ndc": "50242-202-01", "marketing_start_date": "20250211"}], "brand_name": "EVRYSDI", "product_id": "50242-202_a0597961-b4b9-47ec-961a-919fa9ffba95", "dosage_form": "TABLET", "pharm_class": ["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]"], "product_ndc": "50242-202", "generic_name": "Risdiplam", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EVRYSDI", "active_ingredients": [{"name": "RISDIPLAM", "strength": "5 mg/1"}], "application_number": "NDA219285", "marketing_category": "NDA", "marketing_start_date": "20250211", "listing_expiration_date": "20271231"}