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United States · US · US:45802-598_d1aeb8e8-e726-405a-bf9d-7436af66c48b

SUMATRIPTAN

In shortageOrange BookUNIISPLATC N02CC01

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

Identification

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

Packs · 1

  • ndc11
    4580259806
    6 CONTAINER in 1 CARTON (45802-598-06) / 1 SPRAY in 1 CONTAINER (45802-598-00)

Annotations

UNII (FDA Substance ID)
8R78F6L9VO
SUMATRIPTAN
RxCUI 37418
Orange Book
A213465
ABAB
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": {
    "65147b04-0b6b-4d30-9710-d5cdce85e8f5": {
      "match": "brand_token",
      "title": "SUMATRIPTAN INJECTION, SOLUTION [ARMAS PHARMACEUTICALS INC.]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "45802-598_d1aeb8e8-e726-405a-bf9d-7436af66c48b",
  "productndc": "45802-598",
  "dosage_form": "SPRAY",
  "orange_book": {
    "appl_no": "213465",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG/SPRAY",
        "product_no": "001",
        "approval_date": "Sep 21, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG/SPRAY",
        "product_no": "002",
        "approval_date": "Sep 21, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SUMATRIPTAN",
  "shortage_reason": "Sumatriptan Nasal Spray",
  "shortage_status": "current",
  "proprietary_name": "SUMATRIPTAN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213465",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sumatriptan",
  "start_marketing_date": "20201004",
  "active_numerator_strength": "20"
}

Related drugs

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