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Active ingredient

Dihydroergotamine

15 finished FDA listings contain Dihydroergotamine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DIHYDROERGOTAMINE, DIHYDROERGOTAMINE MESYLATE
Dosage forms
Injection, Injection, Solution, Powder, Spray, Spray, Metered
Routes
Intramuscular, Intravenous, Nasal, Subcutaneous
Manufacturers / labelers
13
Strengths listed
1 mg/ml · 4 mg/ml · 5.2 mg/1
Brand names in FDA listings
Atzumi, Brekiya, Trudhesa

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 3418

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020148BAUSCH1997-12-081
ANDA 040453HIKMA2003-06-091
ANDA 206621HIKMA PHARMS2017-09-151
ANDA 212046MILLA PHARMS2020-01-072
ANDA 211393HIKMA2020-02-281
ANDA 212907CIPLA2020-05-201
NDA 213436IMPEL PHARMS2021-09-021
ANDA 216881RUBICON RESEARCH2023-06-222
ANDA 215623GLAND2023-08-181
ANDA 216747BAXTER HLTHCARE CORP2025-01-071
ANDA 215228SOMERSET THERAPS LLC2025-02-261
NDA 217901SATSUMA PHARMS2025-04-301
NDA 215400AMNEAL2025-05-141

Official labeling on DailyMed

Showing the 12 most recent of 15 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.