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United States · US · US:69452-345_4f61a0dc-b9b8-44a3-8fbf-f995a0c3931d

Sumatriptan

In shortageOrange BookUNIISPLATC N02CC01

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

Identification

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

Packs · 1

  • ndc11
    6945234572
    1 BLISTER PACK in 1 CARTON (69452-345-72) / 9 TABLET, FILM COATED in 1 BLISTER PACK (69452-345-60)

Annotations

UNII (FDA Substance ID)
J8BDZ68989
SUMATRIPTAN SUCCINATE
RxCUI 67158
Orange Book
A078284
ABABAB
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": "ORAL",
  "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": "69452-345_4f61a0dc-b9b8-44a3-8fbf-f995a0c3931d",
  "productndc": "69452-345",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078284",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Aug 10, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Aug 10, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "003",
        "approval_date": "Aug 10, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SUMATRIPTAN SUCCINATE",
  "shortage_reason": "Sumatriptan Nasal Spray",
  "shortage_status": "current",
  "proprietary_name": "Sumatriptan",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078284",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sumatriptan",
  "start_marketing_date": "20220218",
  "active_numerator_strength": "50"
}

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