NDC Code(s) : 69097-503-27, 69097-503-31
Packager : Cipla USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dihydroergotamine Mesylate Nasal Dihydroergotamine Mesylate Nasal SPRAY, METERED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-503
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-503-278 in 1 KIT 23/05/2020
11 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:69097-503-311 in 1 KIT 23/05/2020
21 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212907 05/23/2020

LABELER - Cipla USA Inc.(078719707)

REGISTRANT - Cipla USA Inc.(078719707)

Establishment
Name Address ID/FEI Business Operations
Mipharm S.p.A., Italy 514042399 ANALYSIS(69097-503), LABEL(69097-503), MANUFACTURE(69097-503), PACK(69097-503)

PRINCIPAL DISPLAY PANEL

NDC 69097 503 31            Rx Only

Dihydroergotamine Mesylate

           Nasal Spray

4 mg/mL (1 mL/Vial)

FOR NASAL USE ONLY

NOT FOR  INJECTION

Cipla

cipla-vial-labelcipla-vial-label

NDC 69097 503 31            Rx Only

Dihydroergotamine Mesylate

           Nasal Spray

1 vial (4 mg/mL) and 1 Sprayer

NOT FOR INDIVIDUAL SALE

For Nasal Use Only-Not for Injection

Cipla

cipla-vial-labelcipla-inner-carton-label

NDC 69097 503 27            Rx Only

Dihydroergotamine Mesylate

           Nasal Spray

4 mg/mL (1 mL/Vial)

This Kit Contains:

  • 8 Dihydroergotamine Mesylate Nasal Spray Vials
  • 8 Dihydroergotamine Mesylate Nasal Sprayers
  • Administration Instructions
  • Package insert

FOR NASAL USE ONLY

NOT FOR INJECTION

Cipla

cipla-vial-labelcipla-outer-carton-label