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United States · US · US:64896-509_1d8fa8b1-75e6-42af-863d-a775791da7a6
BREKIYA
Orange BookUNIISPLATC N02CA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeN02CA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1164896509024 POUCH in 1 CARTON (64896-509-02) / 1 SYRINGE in 1 POUCH / 1 mL in 1 SYRINGE (64896-509-01)
Annotations
UNII (FDA Substance ID)
81AXN7R2QT
DIHYDROERGOTAMINE MESYLATE
RxCUI 203176
Orange Book
N215400
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "81AXN7R2QT",
"rxcui": "203176",
"inchikey": "ADYPXRFPBQGGAH-UMYZUSPBSA-N",
"display_name": "DIHYDROERGOTAMINE MESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"cdbf5619-767f-4165-aec2-17bdd92d9ca2": {
"match": "brand_token",
"title": "BREKIYA (DIHYDROERGOTAMINE MESYLATE) INJECTION [AMNEAL PHARMACEUTICALS LLC]",
"spl_version": "2",
"published_date": "2025-11-17"
}
},
"productid": "64896-509_1d8fa8b1-75e6-42af-863d-a775791da7a6",
"productndc": "64896-509",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "215400",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "May 14, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIHYDROERGOTAMINE MESYLATE",
"proprietary_name": "BREKIYA",
"active_ingred_unit": "mg/mL",
"application_number": "NDA215400",
"marketing_category": "NDA",
"nonproprietary_name": "Dihydroergotamine Mesylate",
"start_marketing_date": "20250516",
"active_numerator_strength": "1"
}Related drugs
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