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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"
}

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