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United States · US · US:70792-812_803144a8-2d17-47ac-98d0-515198ba722d

Tosymra

In shortageOrange BookUNIISPLATC N02CC01

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

Identification

ManufacturerTonix Medicines, Inc.
CountryUS (United States)
ATC codeN02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7079281259
    1 BLISTER PACK in 1 CARTON (70792-812-59) / 1 BOTTLE, SPRAY in 1 BLISTER PACK / .1 mL in 1 BOTTLE, SPRAY
  • ndc11
    7079281261
    6 BLISTER PACK in 1 CARTON (70792-812-61) / 1 BOTTLE, SPRAY in 1 BLISTER PACK / .1 mL in 1 BOTTLE, SPRAY
  • ndc11
    7079281289
    1 BLISTER PACK in 1 CARTON (70792-812-89) / 1 BOTTLE, SPRAY in 1 BLISTER PACK / .1 mL in 1 BOTTLE, SPRAY

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": "70792-812_803144a8-2d17-47ac-98d0-515198ba722d",
  "productndc": "70792-812",
  "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": "20230701",
  "active_numerator_strength": "10"
}

Related drugs

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