TOSYMRA
- Product NDC
- 0245-0812
- 11-digit product format
- 002450812
- Labeler code
- 0245
- Product ID
- 0245-0812_27349402-73d3-3a2e-e063-6394a90a7099
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sumatriptan
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- NDA210884
- Marketing category
- NDA
- Marketing start
- 2019-07-08
- Substance
- SUMATRIPTAN
- Active strength
- 10 mg/.1mL
- Pharmacologic classes
- Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TOSYMRA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SUMATRIPTAN | 10 mg/.1mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8R78F6L9VO |
| Rxcui | 401978, 2178073 |
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 |
|---|
| 0245-0812-59 | TOSYMRA | 0.1 mL in 1 BOTTLE, SPRAY | SPRAY | 0.1 | | 6 |
| 0245-0812-61 | TOSYMRA | 6 in 1 CARTON | SPRAY | 6 | | 6 |
| 0245-0812-89 | TOSYMRA | 1 in 1 BLISTER PACK | SPRAY | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0245-0812 | TOSYMRA (SUMATRIPTAN) SPRAY [UPSHER-SMITH LABORATORIES, LLC] | 6 | Current NDC, Legacy NDC, 3 package rows | 20241120_015a5cf9-f246-48bc-b91e-cd730a53d8aa.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 |
|---|
| 0245-0812-59 | 00245081259 | 0.1 mL in 1 BOTTLE, SPRAY | 0.1 ml | | | | | Historical |
| 0245-0812-61 | 00245081261 | 6 BLISTER PACK in 1 CARTON (0245-0812-61) / 1 BOTTLE, SPRAY in 1 BLISTER PACK (0245-0812-89) / .1 mL in 1 BOTTLE, SPRAY (0245-0812-59) | 6 blister pack | 2021-09-01 | 0000-00-00 | No | No | Current |
| 0245-0812-89 | 00245081289 | 1 in 1 BLISTER PACK | | | | | | Historical |