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United States · US · US:70720-951_a7c38eaa-3f9a-4b24-8634-bdac6138f983

ZOLADEX

Orange BookUNIISPLATC L02AE03

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

Identification

ManufacturerTerSera Therapeutics LLC
CountryUS (United States)
ATC codeL02AE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7072095130
    1 POUCH in 1 CARTON (70720-951-30) / 1 SYRINGE in 1 POUCH / 1 IMPLANT in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
6YUU2PV0U8
GOSERELIN ACETATE
RxCUI 203146
Orange Book
N020578
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6YUU2PV0U8",
    "rxcui": "203146",
    "inchikey": "IKDXDQDKCZPQSZ-JHYYTBFNSA-N",
    "display_name": "GOSERELIN ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "e4cb3c20-2738-400a-b522-3f36f71fe6c5": {
      "match": "brand_token",
      "title": "ZOLADEX (GOSERELIN) IMPLANT [TERSERA THERAPEUTICS LLC]",
      "spl_version": "8",
      "published_date": "2026-03-26"
    }
  },
  "productid": "70720-951_a7c38eaa-3f9a-4b24-8634-bdac6138f983",
  "productndc": "70720-951",
  "dosage_form": "IMPLANT",
  "orange_book": {
    "appl_no": "020578",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10.8MG BASE",
        "product_no": "001",
        "approval_date": "Jan 11, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GOSERELIN ACETATE",
  "proprietary_name": "ZOLADEX",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020578",
  "marketing_category": "NDA",
  "nonproprietary_name": "goserelin",
  "start_marketing_date": "20180126",
  "active_numerator_strength": "10.8"
}

Related drugs

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