Trudhesa
- Product NDC
- 77530-725
- 11-digit product format
- 775300725
- Labeler code
- 77530
- Product ID
- 77530-725_8118afb5-12dc-4dee-91e8-731286b0c1a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dihydroergotamine mesylate
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Impel Pharmaceuticals LLC
- Application
- NDA213436
- Marketing category
- NDA
- Marketing start
- 2021-09-24
- Substance
- DIHYDROERGOTAMINE MESYLATE
- Active strength
- 4 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
- Trudhesa
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIHYDROERGOTAMINE MESYLATE | 4 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 81AXN7R2QT |
| Rxcui | 2569836, 2569842 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 77530-725-00 | Trudhesa | 1 mL in 1 VIAL, GLASS | SPRAY, METERED | 1 | | 6 |
| 77530-725-00 | Trudhesa | 1 in 1 CARTON | SPRAY, METERED | 1 | | 6 |
| 77530-725-04 | Trudhesa | 1 mL in 1 VIAL, GLASS | SPRAY, METERED | 1 | | 6 |
| 77530-725-04 | Trudhesa | 4 in 1 CARTON | SPRAY, METERED | 4 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 77530-725 | TRUDHESA (DIHYDROERGOTAMINE MESYLATE) SPRAY, METERED [IMPEL PHARMACEUTICALS LLC] | 6 | Current NDC, Legacy NDC, 4 package rows | 20250125_b81397b0-910d-4eb4-8fee-a9a3c9d94d63.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 77530-725-00 | 77530072500 | 1 VIAL, GLASS in 1 CARTON (77530-725-00) / 1 mL in 1 VIAL, GLASS | 2021-09-24 | 0000-00-00 | Yes | No | Current |
| 77530-725-04 | 77530072504 | 4 VIAL, GLASS in 1 CARTON (77530-725-04) / 1 mL in 1 VIAL, GLASS | 2021-09-24 | 0000-00-00 | No | No | Current |