🇺🇸
United States · US · US:83301-0082_51926108-a234-328c-e063-6394a90a24cb
Ganirelix Acetate
Orange BookUNIISPLATC H01CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMullan Pharmaceutical Inc.
CountryUS (United States)
ATC codeH01CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1183301008211 SYRINGE, GLASS in 1 CARTON (83301-0082-1) / .5 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": "83301-0082_51926108-a234-328c-e063-6394a90a24cb",
"productndc": "83301-0082",
"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": "20260113",
"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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