Dihydroergotamine Mesylate (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 1 mL Ampule Label

NDC 61990-0411 -0

1 mL Ampule

Rx only

Dihydroergotamine Mesylate Injection, USP

1 mg/mL

IV, IM, SC

Sterile

Apollo Pharmaceuticals USA Inc.

Ampule-1ml.jpg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 x 1 mL Ampules Carton Label

Carton 5 x 1mL Ampules
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 x 1 mL Ampules Carton Label

Carton 10 x 1mL Ampules
(click image for full-size original)
DIHYDROERGOTAMINE MESYLATE
dihydroergotamine mesylate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61990-0411
Route of Administration INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dihydroergotamine Mesylate (Dihydroergotamine) Dihydroergotamine Mesylate 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Alcohol
Glycerin
Water
Methanesulfonic Acid
Sodium Hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61990-0411-1 5 AMPULE10 AMPULE in 1 CARTON contains a AMPULE (61990-0411-0)
1 NDC:61990-0411-2 5 AMPULE10 AMPULE in 1 CARTON contains a AMPULE (61990-0411-0)
1 NDC:61990-0411-0 1 mL in 1 AMPULE This package is contained within a CARTON (61990-0411-1) and a CARTON (61990-0411-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212046 04/14/2020 03/31/2024
Labeler — Apollo Pharmaceuticals Inc. (202959730)

Revised: 03/2023 Apollo Pharmaceuticals Inc.

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