🇺🇸
United States · US · US:78206-138_8e2e2cd7-1d83-4f9f-85be-d047bf413f98
Ganirelix Acetate
Orange BookUNIISPLATC H01CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOrganon LLC
CountryUS (United States)
ATC codeH01CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1178206138011 BLISTER PACK in 1 CARTON (78206-138-01) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
- ndc1178206138021 BLISTER PACK in 1 CARTON (78206-138-02) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
Annotations
UNII (FDA Substance ID)
56U7906FQW
GANIRELIX ACETATE
RxCUI 259264
Orange Book
N021057
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "56U7906FQW",
"rxcui": "259264",
"inchikey": "OVBICQMTCPFEBS-SATRDZAXSA-N",
"display_name": "GANIRELIX ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"420ce739-2756-4fb4-8a4e-5fab501ab973": {
"match": "brand_token",
"title": "GANIRELIX ACETATE INJECTION, SOLUTION [MULLAN PHARMACEUTICAL INC.]",
"spl_version": "2",
"published_date": "2026-05-13"
}
},
"productid": "78206-138_8e2e2cd7-1d83-4f9f-85be-d047bf413f98",
"productndc": "78206-138",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "021057",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "250MCG/0.5ML",
"product_no": "001",
"approval_date": "Jul 29, 1999"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GANIRELIX ACETATE",
"proprietary_name": "Ganirelix Acetate",
"active_ingred_unit": "ug/.5mL",
"application_number": "NDA021057",
"marketing_category": "NDA",
"nonproprietary_name": "Ganirelix Acetate",
"start_marketing_date": "20210601",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code H01CC01.
- DKFyremadelSUN Pharmaceutical Industries Europe BV
- PLFyremadelSun Pharmaceutical Industries Europe B.V.
- 🇺🇸FyremadelFerring Pharmaceuticals Inc.
- FIFyremadelSun Pharmaceutical Industries Europe B.V.
- NOFyremadelSun Pharmaceutical - Nederland
- BEFyremadel 0.25 mg/0.5 mlSun Pharmaceutical Industries Europe
- GBFyremadel 250micrograms/0.5ml solution for injection pre-filled syringesFerring Pharmaceuticals Ltd
- NLFyremadel, 0,25 mg/0,5 ml oplossing voor injectie in voorgevulde spuitSun Pharmaceutical Industries Europe B.V.
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