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United States · US · US:55566-1010_5b000831-15ef-44ff-9fce-3a2289d5e047
Fyremadel
Orange BookUNIISPLATC H01CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFerring Pharmaceuticals Inc.
CountryUS (United States)
ATC codeH01CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1155566101011 BLISTER PACK in 1 CARTON (55566-1010-1) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
56U7906FQW
GANIRELIX ACETATE
RxCUI 259264
Orange Book
A204246
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": {
"5f0908b5-3551-47fd-95f7-3669b0dff7f1": {
"match": "brand_token",
"title": "FYREMADEL (GANIRELIX ACETATE) INJECTION, SOLUTION [FERRING PHARMACEUTICALS INC.]",
"spl_version": "4",
"published_date": "2025-01-09"
}
},
"productid": "55566-1010_5b000831-15ef-44ff-9fce-3a2289d5e047",
"productndc": "55566-1010",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "204246",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "250MCG/0.5ML",
"product_no": "001",
"approval_date": "Nov 30, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GANIRELIX ACETATE",
"proprietary_name": "Fyremadel",
"active_ingred_unit": "ug/.5mL",
"application_number": "ANDA204246",
"marketing_category": "ANDA",
"nonproprietary_name": "ganirelix acetate",
"start_marketing_date": "20220228",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code H01CC01.
- PLFyremadelSun Pharmaceutical Industries Europe B.V.
- NOFyremadelSun Pharmaceutical - Nederland
- DKFyremadelSUN Pharmaceutical Industries Europe BV
- FIFyremadelSun Pharmaceutical Industries Europe B.V.
- 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.
- DKGanirelix "Orifarm"Orifarm Generics A/S
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