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United States · US · US:0173-0479_f5834e77-047f-43ab-8b9c-37d3b34afc27

IMITREX

In shortageOrange BookUNIISPLATC N02CC01

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

Identification

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

Packs · 1

  • ndc11
    0173047900
    2 SYRINGE in 1 PACKAGE (0173-0479-00) / .5 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
J8BDZ68989
SUMATRIPTAN SUCCINATE
RxCUI 67158
Orange Book
N020080
ABAB
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": {
    "fee7d073-0b99-48f2-7985-0d8cf970894b": {
      "match": "brand_token",
      "title": "IMITREX (SUMATRIPTAN) INJECTION [GLAXOSMITHKLINE LLC]",
      "spl_version": "29",
      "published_date": "2025-12-16"
    }
  },
  "productid": "0173-0479_f5834e77-047f-43ab-8b9c-37d3b34afc27",
  "productndc": "0173-0479",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "020080",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Dec 28, 1992"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Feb 1, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Dec 23, 1996"
      }
    ],
    "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": "IMITREX",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "NDA020080",
  "marketing_category": "NDA",
  "nonproprietary_name": "sumatriptan",
  "start_marketing_date": "19970123",
  "active_numerator_strength": "6"
}

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