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Dihydroergotamine Mesylate

Dihydroergotamine Mesylate Injection, USP

Approved
Approval ID

07a9112c-8c04-4849-8cb3-9463f58731d2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 22, 2023

Manufacturers
FDA

Gland Pharma Limited

DUNS: 918601238

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dihydroergotamine Mesylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68083-466
Application NumberANDA215623
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dihydroergotamine Mesylate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
Effective DateAugust 22, 2023
FDA Product Classification

INGREDIENTS (6)

DIHYDROERGOTAMINE MESYLATEActive
Quantity: 1 mg in 1 mL
Code: 81AXN7R2QT
Classification: ACTIB
METHANESULFONIC ACIDInactive
Code: 12EH9M7279
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 8/22/2023

DESCRIPTION

Dihydroergotamine mesylate is ergotamine hydrogenated in the 9, 10 position as the mesylate salt. Dihydroergotamine mesylate is known chemically as ergotaman-3´,6´,18-trione,9,10-dihydro-12´-hydroxy-2´-methyl-5´-(phenylmethyl)-,(5´α)-, monomethanesulfonate. Its molecular weight is 679.78 and its empirical formula C34H41N5O8S.

The chemical structure is

dhe-structure

Dihydroergotamine mesylate
C34H41N5O8S. Mol. Wt. 679.78

Dihydroergotamine Mesylate Injection, USP is a clear, colorless solution supplied in sterile ampules for intravenous, intramuscular, or subcutaneous administration. Each mL contains 1 mg Dihydroergotamine Mesylate, USP; Alcohol, USP 6.1% by volume; Glycerin, USP 15% by weight; Water for Injection, USP; Methanesulfonic Acid and/or Sodium Hydroxide for pH adjustment (pH range is 3.4 to 4.9).

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