EVRYSDI (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 60 mg/80 mL Bottle Carton

NDC 50242-175-07

Evrysdi®
(risdiplam)
for oral solution

60 mg/80 mL
(0.75 mg/mL)

Attention pharmacist: Evrysdi must beconstituted with water prior to dispensing.

80 mL (2.71 fl oz) total volume after constitution

Rx only

Genentech

10252477

PRINCIPAL DISPLAY PANEL -- 60 mg/80 mL Bottle Carton
(click image for full-size original)
EVRYSDI risdiplam powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-175
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISDIPLAM (RISDIPLAM) RISDIPLAM 0.75 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 16.81 mg in 1 mL
ISOMALT 2.97 mg in 1 mL
MALTODEXTRIN 1.88 mg in 1 mL
TARTARIC ACID 1.51 mg in 1 mL
SODIUM BENZOATE 0.38 mg in 1 mL
POLYETHYLENE GLYCOL, UNSPECIFIED 0.25 mg in 1 mL
SUCRALOSE 0.2 mg in 1 mL
ASCORBIC ACID 0.18 mg in 1 mL
EDETATE DISODIUM 0.09 mg in 1 mL
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY (Strawberry) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50242-175-07 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 80 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (50242-175-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA213535 08/07/2020
Labeler — Genentech Inc. (080129000)
Establishment
Name Address ID/FEI Operations
F. Hoffmann-La Roche AG 482242971 API MANUFACTURE (50242-175), ANALYSIS (50242-175), MANUFACTURE (50242-175), PACK (50242-175), LABEL (50242-175)
Establishment
Name Address ID/FEI Operations
F. Hoffmann-La Roche Ltd. 485244961 ANALYSIS (50242-175), LABEL (50242-175), PACK (50242-175), MANUFACTURE (50242-175)

Revised: 10/2023 Genentech Inc.

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