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United States · US · US:0025-0166_0ce07394-417b-4592-a051-8d63bdafbada
Synarel
Orange BookUNIISPLATC H01CA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeH01CA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
8ENZ0QJW4H
NAFARELIN ACETATE
RxCUI 203147
Orange Book
N019886
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8ENZ0QJW4H",
"rxcui": "203147",
"inchikey": "FSBTYDWUUWLHBD-UDXTWCDOSA-N",
"display_name": "NAFARELIN ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "NASAL",
"spl_meta": {
"d0aa57cb-d2f4-46d7-af43-7c8b06aa81a6": {
"match": "brand_token",
"title": "SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [PFIZER LABORATORIES DIV PFIZER INC]",
"spl_version": "23",
"published_date": "2026-03-10"
}
},
"productid": "0025-0166_0ce07394-417b-4592-a051-8d63bdafbada",
"productndc": "0025-0166",
"dosage_form": "SPRAY, METERED",
"orange_book": {
"appl_no": "019886",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.2MG BASE/SPRAY",
"product_no": "001",
"approval_date": "Feb 13, 1990"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NAFARELIN ACETATE",
"proprietary_name": "Synarel",
"active_ingred_unit": "mg/mL",
"application_number": "NDA019886",
"marketing_category": "NDA",
"nonproprietary_name": "nafarelin acetate",
"start_marketing_date": "19900213",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code H01CA02.
- NOSynarelPfizer
- CZSYNARELPfizer, spol. s r.o., Praha
- CASYNARELPFIZER CANADA ULC
- CZSYNARELPfizer, spol. s r.o., Praha
- IESynarel 200 micrograms/dose Nasal Spray SolutionPfizer Healthcare Ireland Unlimited Company
- GBSynarel 200micrograms/dose nasal sprayPfizer Ltd
- NLSynarel, neusspray 200 microgram per dosisPfizer B.V.
- FISynarelaOrifarm Oy
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