ATZUMI
- Product NDC
- 76978-101
- 11-digit product format
- 769780101
- Labeler code
- 76978
- Product ID
- 76978-101_3b0b0981-a681-4c0c-91fb-b662277e92ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DIHYDROERGOTAMINE MESYLATE
- Dosage form
- POWDER
- Route
- NASAL
- Labeler
- Satsuma Pharmaceuticals, Inc.
- Application
- NDA217901
- Marketing category
- NDA
- Marketing start
- 2025-04-30
- Substance
- DIHYDROERGOTAMINE MESYLATE
- Active strength
- 5.2 mg/1
- 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
- ATZUMI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIHYDROERGOTAMINE MESYLATE | 5.2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 81AXN7R2QT |
| Rxcui | 2714187, 2714192 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76978-101-08 | ATZUMI | 1 in 1 BOTTLE, UNIT-DOSE | POWDER | 1 | | 2 |
| 76978-101-08 | ATZUMI | 8 in 1 CARTON | POWDER | 8 | | 2 |
| 76978-101-11 | ATZUMI | 1 in 1 BOTTLE, UNIT-DOSE | POWDER | 1 | | 2 |
| 76978-101-11 | ATZUMI | 1 in 1 CARTON | POWDER | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76978-101 | ATZUMI (DIHYDROERGOTAMINE MESYLATE) POWDER [SATSUMA PHARMACEUTICALS, INC.] | 2 | Current NDC, 4 package rows | 20250515_0982a44a-dc0c-75c0-e063-6394a90a6d6c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76978-101-08 | 76978010108 | 8 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-08) / 1 POWDER in 1 BOTTLE, UNIT-DOSE | 2025-04-30 | No | No | Current |
| 76978-101-11 | 76978010111 | 1 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-11) / 1 POWDER in 1 BOTTLE, UNIT-DOSE | 2025-04-30 | No | No | Current |