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United States · US · US:62756-520_9035f04f-b353-4883-9ac2-e030f18bfc1c

sumatriptan succinate

In shortageOrange BookUNIISPLATC N02CC01

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

Identification

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

Packs · 7

  • ndc11
    6275652001
    3 BLISTER PACK in 1 CARTON (62756-520-01) / 9 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    6275652008
    100 TABLET, FILM COATED in 1 BOTTLE (62756-520-08)
  • ndc11
    6275652018
    1000 TABLET, FILM COATED in 1 BOTTLE (62756-520-18)
  • ndc11
    6275652069
    9 BLISTER PACK in 1 CARTON (62756-520-69) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    6275652083
    30 TABLET, FILM COATED in 1 BOTTLE (62756-520-83)
  • ndc11
    6275652088
    100 TABLET, FILM COATED in 1 BOTTLE (62756-520-88)
  • ndc11
    6275652093
    9 BLISTER PACK in 1 CARTON (62756-520-93) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
J8BDZ68989
SUMATRIPTAN SUCCINATE
RxCUI 67158
Orange Book
A078295
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": "62756-520_9035f04f-b353-4883-9ac2-e030f18bfc1c",
  "productndc": "62756-520",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078295",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Aug 10, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 50MG BASE",
        "product_no": "002",
        "approval_date": "Aug 10, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "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 succinate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078295",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sumatriptan succinate",
  "start_marketing_date": "20090810",
  "active_numerator_strength": "25"
}

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