DIHYDROERGOTAMINE MESYLATE INJECTION, USP Rx only

Dihydroergotamine Mesylate by

Drug Labeling and Warnings

Dihydroergotamine Mesylate by is a Prescription medication manufactured, distributed, or labeled by Hikma Farmaceutica, Hikma Pharmaceuticals USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIHYDROERGOTAMINE MESYLATE- dihydroergotamine mesylate injection 
Hikma Farmaceutica

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DIHYDROERGOTAMINE MESYLATE INJECTION, USP
Rx only

ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

PRINCIPAL DISPLAY PANEL

NDC 0143-9151-01   Rx only
Dihydroergotamine
Mesylate Injection, USP
1 mg/mL
For IV, IM or SC Use ONLY
1 mL Single-Dose Vial

vial label

NDC 0143-9151-10   Rx only

Dihydroergotamine
Mesylate Injection, USP
1 mg/mL
For Intramuscular, Intravenous or Subcutaneous Use ONLY
10 x 1 mL Single-Dose Vials

Carton
DIHYDROERGOTAMINE MESYLATE 
dihydroergotamine mesylate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62778-336
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIHYDROERGOTAMINE MESYLATE (UNII: 81AXN7R2QT) (DIHYDROERGOTAMINE - UNII:436O5HM03C) DIHYDROERGOTAMINE MESYLATE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
METHANESULFONIC ACID (UNII: 12EH9M7279)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62778-336-2210 in 1 CARTON03/31/202303/31/2023
1NDC: 62778-336-211 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04045303/31/202303/31/2023
Labeler - Hikma Farmaceutica (452742943)
Registrant - Hikma Pharmaceuticals USA Inc. (946499746)

Revised: 2/2024
Document Id: 1f3632e0-09d7-4c7f-9066-0652402362bc
Set id: 2345c909-d0d5-4403-9f6c-4f425366a9ab
Version: 3
Effective Time: 20240207
 
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