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United States · US · US:70720-720_a7101558-afb8-443b-8c26-a238e26bb40c
PRIALT
Orange BookUNIISPLATC N02BG08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTerSera Therapeutics LLC
CountryUS (United States)
ATC codeN02BG08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170720720101 VIAL, GLASS in 1 CARTON (70720-720-10) / 1 mL in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
T2I226K69M
ZICONOTIDE ACETATE
RxCUI 486126
Orange Book
N021060
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "T2I226K69M",
"rxcui": "486126",
"inchikey": null,
"display_name": "ZICONOTIDE ACETATE",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRATHECAL",
"spl_meta": {
"b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1": {
"match": "brand_token",
"title": "PRIALT (ZICONOTIDE ACETATE) INJECTION, SOLUTION [TERSERA THERAPEUTICS LLC]",
"spl_version": "6",
"published_date": "2025-07-14"
}
},
"productid": "70720-720_a7101558-afb8-443b-8c26-a238e26bb40c",
"productndc": "70720-720",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "021060",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "500MCG/20ML (25MCG/ML)",
"product_no": "001",
"approval_date": "Dec 28, 2004"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MCG/1ML (100MCG/ML)",
"product_no": "002",
"approval_date": "Dec 28, 2004"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MCG/2ML (100MCG/ML)",
"product_no": "003",
"approval_date": "Dec 28, 2004"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "500MCG/5ML (100MCG/ML)",
"product_no": "004",
"approval_date": "Dec 28, 2004"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZICONOTIDE ACETATE",
"proprietary_name": "PRIALT",
"active_ingred_unit": "ug/mL",
"application_number": "NDA021060",
"marketing_category": "NDA",
"nonproprietary_name": "ziconotide acetate",
"start_marketing_date": "20181015",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N02BG08.
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