🇺🇸
United States · US · US:67184-0574_edcb57c8-5b08-4076-b67c-93d6d610525d
Ganirelix Acetate
Orange BookUNIISPLATC H01CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerQilu Pharmaceutical Co., Ltd.
CountryUS (United States)
ATC codeH01CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167184057411 BLISTER PACK in 1 CARTON (67184-0574-1) / 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
A218855
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": "67184-0574_edcb57c8-5b08-4076-b67c-93d6d610525d",
"productndc": "67184-0574",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "218855",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "250MCG/0.5ML",
"product_no": "001",
"approval_date": "Apr 23, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GANIRELIX ACETATE",
"proprietary_name": "Ganirelix Acetate",
"active_ingred_unit": "ug/.5mL",
"application_number": "ANDA218855",
"marketing_category": "ANDA",
"nonproprietary_name": "Ganirelix Acetate",
"start_marketing_date": "20250515",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code H01CC01.
- PLFyremadelSun Pharmaceutical Industries Europe B.V.
- FIFyremadelSun Pharmaceutical Industries Europe B.V.
- 🇺🇸FyremadelFerring Pharmaceuticals Inc.
- NOFyremadelSun Pharmaceutical - Nederland
- DKFyremadelSUN Pharmaceutical Industries Europe BV
- 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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