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 POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

risdiplam .75 mg/mL

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-175
Product ID 50242-175_a0597961-b4b9-47ec-961a-919fa9ffba95
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213535
Listing Expiration 2027-12-31
Marketing Start 2020-08-07

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 50242175
Hyphenated Format 50242-175

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 NDA213535 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .75 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (50242-175-07) / 80 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

50242-175-07 1 BOTTLE, GLASS in 1 CARTON (50242-175-07) / 80 mL in 1 BOTTLE, GLASS

Ingredients (1)

risdiplam (.75 mg/mL)

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, GLASS in 1 CARTON (50242-175-07)  / 80 mL in 1 BOTTLE, GLASS", "package_ndc": "50242-175-07", "marketing_start_date": "20200807"}], "brand_name": "EVRYSDI", "product_id": "50242-175_a0597961-b4b9-47ec-961a-919fa9ffba95", "dosage_form": "POWDER, FOR SOLUTION", "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": "50242-175", "generic_name": "Risdiplam", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EVRYSDI", "active_ingredients": [{"name": "RISDIPLAM", "strength": ".75 mg/mL"}], "application_number": "NDA213535", "marketing_category": "NDA", "marketing_start_date": "20200807", "listing_expiration_date": "20271231"}