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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
- ndc1101730479002 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"strength": "EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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"
}Related drugs
Other records sharing ATC code N02CC01.
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