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United States · US · US:42847-311_1b32d254-9be1-4601-9a8c-a039d4cd5a01

Onzetra Xsail

In shortageOrange BookUNIISPLATC N02CC01

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

Identification

ManufacturerCurrax Pharmaceuticals LLC
CountryUS (United States)
ATC codeN02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4284731108
    8 POUCH in 1 CARTON (42847-311-08) / 2 CAPSULE in 1 POUCH

Annotations

UNII (FDA Substance ID)
J8BDZ68989
SUMATRIPTAN SUCCINATE
RxCUI 67158
Orange Book
N206099
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": "NASAL",
  "spl_meta": {
    "a8a9889e-69b9-4a57-b8c0-d40b1025c559": {
      "match": "brand_token",
      "title": "ONZETRA XSAIL (SUMATRIPTAN SUCCINATE) CAPSULE [CURRAX PHARMACEUTICALS LLC]",
      "spl_version": "4",
      "published_date": "2024-04-23"
    }
  },
  "productid": "42847-311_1b32d254-9be1-4601-9a8c-a039d4cd5a01",
  "productndc": "42847-311",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "206099",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 11MG BASE",
        "product_no": "001",
        "approval_date": "Jan 27, 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": "Onzetra Xsail",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA206099",
  "marketing_category": "NDA",
  "nonproprietary_name": "sumatriptan succinate",
  "start_marketing_date": "20151001",
  "active_numerator_strength": "11"
}

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