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United States · US · US:59365-5128_226b4d58-044f-4016-9da3-6fd6a37645dd
ParaGard T 380A
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCooperSurgical, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159365512811 POUCH in 1 CARTON (59365-5128-1) / 1 INTRAUTERINE DEVICE in 1 POUCH
Annotations
UNII (FDA Substance ID)
789U1901C5
COPPER
RxCUI 2837
Orange Book
N018680
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "789U1901C5",
"rxcui": "2837",
"inchikey": "RYGMFSIKBFXOCR-UHFFFAOYSA-N",
"display_name": "COPPER",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAUTERINE",
"spl_meta": {
"5ea7ce51-b87a-485e-b841-99466a07a4b2": {
"match": "brand_token",
"title": "PARAGARD T 380A (COPPER) INTRAUTERINE DEVICE [COOPERSURGICAL, INC.]",
"spl_version": "6",
"published_date": "2025-07-04"
}
},
"productid": "59365-5128_226b4d58-044f-4016-9da3-6fd6a37645dd",
"productndc": "59365-5128",
"dosage_form": "INTRAUTERINE DEVICE",
"orange_book": {
"appl_no": "018680",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "309MG/COPPER",
"product_no": "001",
"approval_date": "Nov 15, 1984"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COPPER",
"proprietary_name": "ParaGard T 380A",
"active_ingred_unit": "mg/1",
"application_number": "NDA018680",
"marketing_category": "NDA",
"nonproprietary_name": "Copper",
"start_marketing_date": "20171102",
"active_numerator_strength": "313.4"
}Access this data programmatically
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