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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
- ndc1100093359011 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"
}Related drugs
Other records sharing ATC code G02AD02.
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