Back to search
🇺🇸

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

  • ndc11
    7072072010
    1 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.

Access this data programmatically

Query PRIALT and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.