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United States · US · US:65145-118_eeefceae-7dbe-4215-90b2-59b5d509547f

Sumatriptan

In shortageOrange BookUNIISPLATC N02CC01

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

Identification

ManufacturerCaplin Steriles Limited
CountryUS (United States)
ATC codeN02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6514511805
    5 VIAL in 1 CARTON (65145-118-05) / .5 mL in 1 VIAL (65145-118-01)

Annotations

UNII (FDA Substance ID)
J8BDZ68989
SUMATRIPTAN SUCCINATE
RxCUI 67158
Orange Book
A213998
AP
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": {
    "65147b04-0b6b-4d30-9710-d5cdce85e8f5": {
      "match": "brand_token",
      "title": "SUMATRIPTAN INJECTION, SOLUTION [ARMAS PHARMACEUTICALS INC.]",
      "spl_version": "2",
      "published_date": "2026-06-02"
    }
  },
  "productid": "65145-118_eeefceae-7dbe-4215-90b2-59b5d509547f",
  "productndc": "65145-118",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "213998",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Jul 13, 2021"
      }
    ],
    "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/.5mL",
  "application_number": "ANDA213998",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sumatriptan",
  "start_marketing_date": "20240928",
  "active_numerator_strength": "6"
}

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