BREKIYA
- Product NDC
- 64896-509
- 11-digit product format
- 648960509
- Labeler code
- 64896
- Product ID
- 64896-509_1d8fa8b1-75e6-42af-863d-a775791da7a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dihydroergotamine Mesylate
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- NDA215400
- Marketing category
- NDA
- Marketing start
- 2025-05-16
- Substance
- DIHYDROERGOTAMINE MESYLATE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Ergotamine Derivative [EPC], Ergotamines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BREKIYA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIHYDROERGOTAMINE MESYLATE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 81AXN7R2QT |
| Rxcui | 2714308, 2714315 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64896-509-01 | BREKIYA | 1 mL in 1 SYRINGE | INJECTION | 1 | | 2 |
| 64896-509-02 | BREKIYA | 1 in 1 POUCH | INJECTION | 1 | | 2 |
| 64896-509-02 | BREKIYA | 4 in 1 CARTON | INJECTION | 4 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64896-509 | BREKIYA (DIHYDROERGOTAMINE MESYLATE) INJECTION [AMNEAL PHARMACEUTICALS LLC] | 1 | Current NDC, 3 package rows | 20250519_cdbf5619-767f-4165-aec2-17bdd92d9ca2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64896-509-01 | 64896050901 | 1 mL in 1 SYRINGE | 1 ml | | | | Historical |
| 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) | 4 pouch | 2025-05-16 | No | No | Current |