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NDC 00245-0812-61 TOSYMRA 10 mg/.1mL Details
TOSYMRA 10 mg/.1mL
TOSYMRA is a NASAL SPRAY in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Upsher-Smith Laboratories, LLC. The primary component is SUMATRIPTAN.
MedlinePlus Drug Summary
Sumatriptan nasal products are used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound and light). Sumatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels around the brain, stopping pain signals from being sent to the brain, and blocking the release of natural substances that cause pain, nausea, and other symptoms of migraine. Sumatriptan does not prevent migraine attacks or reduce the number of headaches you have.
Related Packages: 00245-0812-61Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Sumatriptan Nasal
Product Information
| NDC | 00245-0812 |
|---|---|
| Product ID | 0245-0812_cc19c8b4-3c96-494b-baa5-f02afdcfc0d7 |
| Associated GPIs | 67406070002020 |
| GCN Sequence Number | 030741 |
| GCN Sequence Number Description | sumatriptan SPRAY 10 MG NASAL |
| HIC3 | H3F |
| HIC3 Description | ANTIMIGRAINE PREPARATIONS |
| GCN | 50743 |
| HICL Sequence Number | 012779 |
| HICL Sequence Number Description | SUMATRIPTAN |
| Brand/Generic | Brand |
| Proprietary Name | TOSYMRA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sumatriptan |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SPRAY |
| Route | NASAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/.1mL |
| Substance Name | SUMATRIPTAN |
| Labeler Name | Upsher-Smith Laboratories, LLC |
| Pharmaceutical Class | Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA210884 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00245-0812-61 (00245081261)
| NDC Package Code | 0245-0812-61 |
|---|---|
| Billing NDC | 00245081261 |
| Package | 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) |
| Marketing Start Date | 2021-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |