tosymra

Generic: sumatriptan

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tosymra
Generic Name sumatriptan
Labeler upsher-smith laboratories, llc
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

sumatriptan 10 mg/.1mL

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0245-0812
Product ID 0245-0812_27349402-73d3-3a2e-e063-6394a90a7099
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210884
Listing Expiration 2026-12-31
Marketing Start 2019-07-08

Pharmacologic Class

Established (EPC)
serotonin-1b and serotonin-1d receptor agonist [epc]
Mechanism of Action
serotonin 1b receptor agonists [moa] serotonin 1d receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02450812
Hyphenated Format 0245-0812

Supplemental Identifiers

RxCUI
401978 2178073
UNII
8R78F6L9VO
NUI
N0000175763 N0000175764 N0000175765

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tosymra (source: ndc)
Generic Name sumatriptan (source: ndc)
Application Number NDA210884 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/.1mL
source: ndc
Packaging
  • 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)
source: ndc

Packages (1)

0245-0812-61 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)

Ingredients (1)

sumatriptan (10 mg/.1mL)

Linked Drug Pages (1)

TOSYMRA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "27349402-73d3-3a2e-e063-6394a90a7099", "openfda": {"nui": ["N0000175763", "N0000175764", "N0000175765"], "unii": ["8R78F6L9VO"], "rxcui": ["401978", "2178073"], "spl_set_id": ["015a5cf9-f246-48bc-b91e-cd730a53d8aa"], "pharm_class_epc": ["Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]"], "pharm_class_moa": ["Serotonin 1b Receptor Agonists [MoA]", "Serotonin 1d Receptor Agonists [MoA]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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)", "package_ndc": "0245-0812-61", "marketing_start_date": "20210901"}], "brand_name": "TOSYMRA", "product_id": "0245-0812_27349402-73d3-3a2e-e063-6394a90a7099", "dosage_form": "SPRAY", "pharm_class": ["Serotonin 1b Receptor Agonists [MoA]", "Serotonin 1d Receptor Agonists [MoA]", "Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]"], "product_ndc": "0245-0812", "generic_name": "sumatriptan", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOSYMRA", "active_ingredients": [{"name": "SUMATRIPTAN", "strength": "10 mg/.1mL"}], "application_number": "NDA210884", "marketing_category": "NDA", "marketing_start_date": "20190708", "listing_expiration_date": "20261231"}