NDC 70529-030

Dromelate

Dihydroergotamine Mesylate

Dromelate is a Intramuscular; Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by It3 Medical Llc. The primary component is Dihydroergotamine Mesylate.

Product ID70529-030_15b2b0cd-f103-4d3a-b8d7-18456cb3dfde
NDC70529-030
Product TypeHuman Prescription Drug
Proprietary NameDromelate
Generic NameDihydroergotamine Mesylate
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2017-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA040475
Labeler NameIT3 Medical LLC
Substance NameDIHYDROERGOTAMINE MESYLATE
Active Ingredient Strength1 mg/mL
Pharm ClassesErgotamine Derivative [EPC], Ergotamines [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70529-030-01

1 AMPULE in 1 PACKAGE (70529-030-01) > 1 mL in 1 AMPULE
Marketing Start Date2017-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70529-030-01 [70529003001]

Dromelate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040475
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-01

Drug Details

Active Ingredients

IngredientStrength
DIHYDROERGOTAMINE MESYLATE1 mg/mL

OpenFDA Data

SPL SET ID:2367e853-1109-4c23-a177-6829304832e8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861672

    • Pharmacological Class

    • Ergotamines [CS]
    • Ergotamine Derivative [EPC]

    NDC Crossover Matching brand name "Dromelate" or generic name "Dihydroergotamine Mesylate"

    NDCBrand NameGeneric Name
    70529-030DromelateDihydroergotamine Mesylate
    66490-041D.H.E. 45Dihydroergotamine Mesylate
    0143-9273Dihydroergotamine MesylateDihydroergotamine Mesylate
    0574-0850Dihydroergotamine MesylateDihydroergotamine Mesylate
    0574-0851dihydroergotamine mesylatedihydroergotamine mesylate
    24201-463Dihydroergotamine MesylateDihydroergotamine Mesylate
    25021-609dihydroergotamine mesylatedihydroergotamine mesylate
    61990-0411Dihydroergotamine MesylateDihydroergotamine Mesylate
    68682-357Dihydroergotamine Mesylatedihydroergotamine mesylate
    81284-411Dihydroergotamine MesylateDihydroergotamine Mesylate
    82454-0411Dihydroergotamine MesylateDihydroergotamine Mesylate
    0187-0245Migranaldihydroergotamine mesylate
    77530-725TrudhesaDihydroergotamine mesylate
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.