NDC Code(s) : 67386-130-51, 67386-130-91
Packager : Lundbeck Pharmaceuticals LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Vyeptieptinezumab-jjmr INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67386-130
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPTINEZUMAB(UNII: 8202AY8I7H)
(EPTINEZUMAB - UNII:8202AY8I7H) 		EPTINEZUMAB100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE(UNII: 4QD397987E)
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE(UNII: X573657P6P)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SORBITOL(UNII: 506T60A25R)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67386-130-511 in 1 CARTON 21/02/2020
11 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2NDC:67386-130-911 in 1 CARTON 04/01/2023
21 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761119 02/21/2020

LABELER - Lundbeck Pharmaceuticals LLC(009582068)

PRINCIPAL DISPLAY PANEL

NDC 67386-130-51

VYEPTITM (vye ep' tee)

(eptinezumab-jjmr)

injection, for intravenous use

100 mg/mL

NDC 67386-130-51 VYEPTITM (vye ep

PRINCIPAL DISPLAY PANEL

NDC 67386-130-91

VYEPTITM (vye ep' tee)

(eptinezumab-jjmr)

injection, for intravenous use

100 mg/mL

Professional Sample

NDC 67386-130-91 VYEPTITM (vye ep

Professional Sample