NDC Code(s) : 73063-035-04, 73063-035-03
Packager : Amylyx Pharmaceuticals Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

RELYVRIOsodium phenylbutyrate/taurursodiol POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:73063-035
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM PHENYLBUTYRATE(UNII: NT6K61736T)
(PHENYLBUTYRIC ACID - UNII:7WY7YBI87E) 		SODIUM PHENYLBUTYRATE3 g
TAURURSODIOL DIHYDRATE(UNII: U7XRV7RZ1I)
(TAURURSODIOL - UNII:60EUX8MN5X) 		TAURURSODIOL1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL(UNII: 506T60A25R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SUCRALOSE(UNII: 96K6UQ3ZD4)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
DEXTRATES(UNII: G263MI44RU)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)
ACACIA(UNII: 5C5403N26O)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
Product Characteristics
Color white, yellow Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:73063-035-047 in 1 CARTON Type 0: Not a Combination Product29/09/2022
2NDC:73063-035-0356 in 1 CARTON Type 0: Not a Combination Product29/09/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA216660 09/29/2022

LABELER - Amylyx Pharmaceuticals Inc(080954012)

PRINCIPAL DISPLAY PANEL

RELYVRIO 3 g sodium phenylbutyrate and 1 g taurursodiol per packet

NDC 73063-035-04

Carton of 7 single-dose packets

Carton of 7 single-dose packets

PRINCIPAL DISPLAY PANEL

RELYVRIO 3 g sodium phenylbutyrate and 1 g taurursodiol per packet

NDC 73063-035-03

Carton of 56 single-dose packets, contained in 4 boxes with 14 single-dose packets per box

Carton of 56 single-dose packets