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United States · US · US:70792-809_82e7bcd6-ebe3-4e29-85c5-f01c901ee0a1

Zembrace SymTouch

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
    7079280938
    4 BLISTER PACK in 1 CARTON (70792-809-38) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE
  • ndc11
    7079280939
    1 BLISTER PACK in 1 CARTON (70792-809-39) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE
  • ndc11
    7079280989
    1 BLISTER PACK in 1 CARTON (70792-809-89) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
J8BDZ68989
SUMATRIPTAN SUCCINATE
RxCUI 67158
Orange Book
N208223
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sumatriptan Nasal Spray
Raw payload (JSON)
{
  "unii": {
    "unii": "J8BDZ68989",
    "rxcui": "67158",
    "inchikey": "PORMUFZNYQJOEI-UHFFFAOYSA-N",
    "display_name": "SUMATRIPTAN SUCCINATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "6e5b104f-2b9e-416e-92fb-ef1bdaea867d": {
      "match": "brand_token",
      "title": "ZEMBRACE SYMTOUCH (SUMATRIPTAN SUCCINATE) INJECTION, SOLUTION [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "8",
      "published_date": "2026-01-14"
    }
  },
  "productid": "70792-809_82e7bcd6-ebe3-4e29-85c5-f01c901ee0a1",
  "productndc": "70792-809",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "208223",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)",
        "product_no": "001",
        "approval_date": "Jan 28, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SUMATRIPTAN SUCCINATE",
  "shortage_reason": "Sumatriptan Nasal Spray",
  "shortage_status": "current",
  "proprietary_name": "Zembrace SymTouch",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "NDA208223",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sumatriptan Succinate",
  "start_marketing_date": "20230701",
  "active_numerator_strength": "3"
}

Related drugs

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