Prescription drug · NDA
Brekiya (dihydroergotamine mesylate) NDC 64896-509
Dihydroergotamine mesylate 1 mg/mL · Injection · Subcutaneous · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64896-509-02 | 64896050902 | 4 POUCH in 1 CARTON (64896-509-02) / 1 SYRINGE in 1 POUCH / 1 mL in 1 SYRINGE (64896-509-01)Marketed from May 16, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Brekiya
- Generic name (nonproprietary)
- dihydroergotamine mesylate
- Active ingredients
- Dihydroergotamine mesylate — 1 mg/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215400
- Marketing start
- Listing expires
- Other FDA classes
- Ergotamines (Chemical structure)
- Identifiers
- Product ID 64896-509_1d8fa8b1-75e6-42af-863d-a775791da7a6SPL ID 1d8fa8b1-75e6-42af-863d-a775791da7a6SPL set ID cdbf5619-767f-4165-aec2-17bdd92d9ca2RxCUI 2714308, 2714315UNII 81AXN7R2QTUPC 0364896509017
- Pharmacologic class
- Ergotamine Derivative
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N464896050902followed by a unit qualifier and the quantityPackage 64896-0509-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
BREKIYA is indicated for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults. Limitations of Use BREKIYA is not indicated for the preventive treatment of migraine. BREKIYA is not indicated for the management of hemiplegic migraine or migraine with brainstem aura. BREKIYA is an ergotamine derivative indicated for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults. ( 1 ) Limitations of Use BREKIYA is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura. ( 1 )
Excerpt only. Read the full label for complete information.