brekiya

Generic: dihydroergotamine mesylate

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name brekiya
Generic Name dihydroergotamine mesylate
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

dihydroergotamine mesylate 1 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 64896-509
Product ID 64896-509_1d8fa8b1-75e6-42af-863d-a775791da7a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215400
Listing Expiration 2026-12-31
Marketing Start 2025-05-16

Pharmacologic Class

Classes
ergotamine derivative [epc] ergotamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64896509
Hyphenated Format 64896-509

Supplemental Identifiers

RxCUI
2714308 2714315
UPC
0364896509017
UNII
81AXN7R2QT

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name brekiya (source: ndc)
Generic Name dihydroergotamine mesylate (source: ndc)
Application Number NDA215400 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 4 POUCH in 1 CARTON (64896-509-02) / 1 SYRINGE in 1 POUCH / 1 mL in 1 SYRINGE (64896-509-01)
source: ndc

Packages (1)

64896-509-02 4 POUCH in 1 CARTON (64896-509-02) / 1 SYRINGE in 1 POUCH / 1 mL in 1 SYRINGE (64896-509-01)

Ingredients (1)

dihydroergotamine mesylate (1 mg/mL)

Linked Drug Pages (1)

BREKIYA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "1d8fa8b1-75e6-42af-863d-a775791da7a6", "openfda": {"upc": ["0364896509017"], "unii": ["81AXN7R2QT"], "rxcui": ["2714308", "2714315"], "spl_set_id": ["cdbf5619-767f-4165-aec2-17bdd92d9ca2"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 POUCH in 1 CARTON (64896-509-02)  / 1 SYRINGE in 1 POUCH / 1 mL in 1 SYRINGE (64896-509-01)", "package_ndc": "64896-509-02", "marketing_start_date": "20250516"}], "brand_name": "BREKIYA", "product_id": "64896-509_1d8fa8b1-75e6-42af-863d-a775791da7a6", "dosage_form": "INJECTION", "pharm_class": ["Ergotamine Derivative [EPC]", "Ergotamines [CS]"], "product_ndc": "64896-509", "generic_name": "Dihydroergotamine Mesylate", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BREKIYA", "active_ingredients": [{"name": "DIHYDROERGOTAMINE MESYLATE", "strength": "1 mg/mL"}], "application_number": "NDA215400", "marketing_category": "NDA", "marketing_start_date": "20250516", "listing_expiration_date": "20261231"}