Dihydroergotamine Mesylate
- Product NDC
- 68083-466
- 11-digit product format
- 680830466
- Labeler code
- 68083
- Product ID
- 68083-466_a1a6aeb0-fb61-46bf-8b3f-7ed1a9cc21ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dihydroergotamine Mesylate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA215623
- Marketing category
- ANDA
- Marketing start
- 2023-08-18
- 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
- Dihydroergotamine Mesylate
- 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 | 861672 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-466-10 | Dihydroergotamine Mesylate | 1 mL in 1 AMPULE | INJECTION | 1 | | 7 |
| 68083-466-10 | Dihydroergotamine Mesylate | 10 in 1 CARTON | INJECTION | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-466 | DIHYDROERGOTAMINE MESYLATE INJECTION [GLAND PHARMA LIMITED] | 7 | Current NDC, 2 package rows | 20230823_07a9112c-8c04-4849-8cb3-9463f58731d2.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 |
|---|
| 68083-466-10 | 68083046610 | 10 AMPULE in 1 CARTON (68083-466-10) / 1 mL in 1 AMPULE | 10 ampule | 2023-08-18 | No | No | Current |