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United States · US · US:0245-0812_27349402-73d3-3a2e-e063-6394a90a7099

TOSYMRA

In shortageOrange BookUNIISPLATC N02CC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeN02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0245081261
    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)

Annotations

UNII (FDA Substance ID)
8R78F6L9VO
SUMATRIPTAN
RxCUI 37418
Orange Book
N210884
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sumatriptan Nasal Spray
Raw payload (JSON)
{
  "unii": {
    "unii": "8R78F6L9VO",
    "rxcui": "37418",
    "inchikey": "KQKPFRSPSRPDEB-UHFFFAOYSA-N",
    "display_name": "SUMATRIPTAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "spl_meta": {
    "d9f682f0-d50a-4fe6-ab1b-e5a7ec27b3a5": {
      "match": "brand_token",
      "title": "TOSYMRA (SUMATRIPTAN) SPRAY [TONIX MEDICINES, INC.]",
      "spl_version": "3",
      "published_date": "2025-03-10"
    }
  },
  "productid": "0245-0812_27349402-73d3-3a2e-e063-6394a90a7099",
  "productndc": "0245-0812",
  "dosage_form": "SPRAY",
  "orange_book": {
    "appl_no": "210884",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG/SPRAY",
        "product_no": "001",
        "approval_date": "Jan 25, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SUMATRIPTAN",
  "shortage_reason": "Sumatriptan Nasal Spray",
  "shortage_status": "current",
  "proprietary_name": "TOSYMRA",
  "active_ingred_unit": "mg/.1mL",
  "application_number": "NDA210884",
  "marketing_category": "NDA",
  "nonproprietary_name": "sumatriptan",
  "start_marketing_date": "20190708",
  "active_numerator_strength": "10"
}

Related drugs

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