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United States · US · US:0009-3359_e72f678f-ff11-47d7-94ea-186113ec3fbd

Prepidil

Orange BookUNIISPLATC G02AD02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPharmacia & Upjohn Company LLC
CountryUS (United States)
ATC codeG02AD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0009335901
    1 SYRINGE in 1 CARTON (0009-3359-01) / 3 g in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
K7Q1JQR04M
DINOPROSTONE
RxCUI 3478
Orange Book
N019617
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "K7Q1JQR04M",
    "rxcui": "3478",
    "inchikey": "XEYBRNLFEZDVAW-ARSRFYASSA-N",
    "display_name": "DINOPROSTONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "VAGINAL",
  "spl_meta": {
    "ab03de5b-782c-4f81-a8dc-7ef9969dd0cf": {
      "match": "brand_token",
      "title": "PREPIDIL (DINOPROSTONE) GEL [PHARMACIA & UPJOHN COMPANY LLC]",
      "spl_version": "23",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0009-3359_e72f678f-ff11-47d7-94ea-186113ec3fbd",
  "productndc": "0009-3359",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "019617",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.5MG/3GM",
        "product_no": "001",
        "approval_date": "Dec 9, 1992"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DINOPROSTONE",
  "proprietary_name": "Prepidil",
  "active_ingred_unit": "mg/3g",
  "application_number": "NDA019617",
  "marketing_category": "NDA",
  "nonproprietary_name": "dinoprostone",
  "start_marketing_date": "19921209",
  "active_numerator_strength": ".5"
}

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