NDC Code(s) : 72888-096-18, 72888-096-19, 72888-096-34
Packager : Advagen Pharma Ltd

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dihydroergotamine mesylateDihydroergotamine mesylate SPRAY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72888-096
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIHYDROERGOTAMINE MESYLATE(UNII: 81AXN7R2QT)
(DIHYDROERGOTAMINE - UNII:436O5HM03C) 		DIHYDROERGOTAMINE MESYLATE4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CAFFEINE(UNII: 3G6A5W338E)
ANHYDROUS DEXTROSE(UNII: 5SL0G7R0OK)
CARBON DIOXIDE(UNII: 142M471B3J)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color yellow (colorless to light yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72888-096-198 in 1 KIT 23/06/2023
1NDC:72888-096-181 in 1 KIT
11 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
2NDC:72888-096-341 in 1 KIT 23/06/2023
21 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216881 06/23/2023

LABELER - Advagen Pharma Ltd(051627256)

Establishment
Name Address ID/FEI Business Operations
Mipharm, S.p.A. 514042399 manufacture(72888-096), analysis(72888-096), pack(72888-096), label(72888-096)

PRINCIPAL DISPLAY PANEL

Dihydroergotamine Mesylate Nasal Spray - NDC 72888-096-18 - 1 Unit (1mL Vial and 1 Sprayer) in 1 Carton Label

Dihydroergotamine Mesylate Nasal Spray - NDC 72888­096-18 - Single Carton Label

Dihydroergotamine Mesylate Nasal Spray - NDC 72888-096-18 - 1mL Vial Container Label

Dihydroergotamine Mesylate Nasal Spray - NDC 72888­096-18 - Single Carton Label

Dihydroergotamine Mesylate Nasal Spray - NDC 72888-096-19 - 8 Unit's (Each unit contains 1 Vial and 1 Sprayer) in 1 Carton Label

Dihydroergotamine Mesylate Nasal Spray - NDC 72888­096-18 - Single Carton Label

Dihydroergotamine Mesylate Nasal Spray - NDC 72888-096-34 - 1mL Vial and 1 Sprayer in 1 Carton Label

Dihydroergotamine Mesylate Nasal Spray - NDC 72888­096-18 - Single Carton Label