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United States · US · US:70720-950_c48edbf8-425f-4e11-8892-467e868d9fba
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
- ndc1170720950361 POUCH in 1 CARTON (70720-950-36) / 1 SYRINGE in 1 POUCH / 1 IMPLANT in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
6YUU2PV0U8
GOSERELIN ACETATE
RxCUI 203146
Orange Book
N019726
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": "70720-950_c48edbf8-425f-4e11-8892-467e868d9fba",
"productndc": "70720-950",
"dosage_form": "IMPLANT",
"orange_book": {
"appl_no": "019726",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 3.6MG BASE",
"product_no": "001",
"approval_date": "Dec 29, 1989"
}
],
"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": "NDA019726",
"marketing_category": "NDA",
"nonproprietary_name": "goserelin",
"start_marketing_date": "20180331",
"active_numerator_strength": "3.6"
}Related drugs
Other records sharing ATC code L02AE03.
- GBGoserelin 3.6mg implant pre-filled syringesA A H Pharmaceuticals Ltd
- GBNovgos 3.6mg implant pre-filled syringesGenus Pharmaceuticals Ltd
- PLReseligoZentiva, k.s.
- ISReseligoAlvogen ehf.
- PLReseligoZentiva, k.s.
- ISReseligoZentiva k.s.*
- CZRESELIGOAlvogen Pharma Trading Europe EOOD, Sofia
- CZRESELIGOAlvogen Pharma Trading Europe EOOD, Sofia
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