Dihydroergotamine Mesylate Nasal
- Product NDC
- 69097-503
- 11-digit product format
- 690970503
- Labeler code
- 69097
- Product ID
- 69097-503_68a5f507-1f3a-412d-8321-1e8d74cc31bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dihydroergotamine Mesylate Nasal
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA212907
- Marketing category
- ANDA
- Marketing start
- 2020-05-23
- 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
- Dihydroergotamine Mesylate Nasal
- 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 | 861668 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69097-503-27 | Dihydroergotamine Mesylate Nasal | 8 in 1 KIT | SPRAY, METERED | 8 | | 10 |
| 69097-503-27 | Dihydroergotamine Mesylate Nasal | 1 mL in 1 VIAL | SPRAY, METERED | 1 | | 10 |
| 69097-503-31 | Dihydroergotamine Mesylate Nasal | 1 mL in 1 VIAL | SPRAY, METERED | 1 | | 10 |
| 69097-503-31 | Dihydroergotamine Mesylate Nasal | 1 in 1 KIT | SPRAY, METERED | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-503 | DIHYDROERGOTAMINE MESYLATE NASAL SPRAY, METERED [CIPLA USA INC.] | 9 | Current NDC, Legacy NDC, 4 package rows | 20240131_1ecb2311-eee3-4230-a019-a3496308cff1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69097-503-27 | 69097050327 | 8 VIAL in 1 KIT (69097-503-27) / 1 mL in 1 VIAL | 8 vial | 2020-05-23 | 0000-00-00 | No | No | Current |
| 69097-503-31 | 69097050331 | 1 VIAL in 1 KIT (69097-503-31) / 1 mL in 1 VIAL | 1 vial | 2020-05-23 | 0000-00-00 | No | No | Current |