prepidil

Generic: dinoprostone

Labeler: pharmacia & upjohn company llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name prepidil
Generic Name dinoprostone
Labeler pharmacia & upjohn company llc
Dosage Form GEL
Routes
VAGINAL
Active Ingredients

dinoprostone .5 mg/3g

Manufacturer
Pharmacia & Upjohn Company LLC

Identifiers & Regulatory

Product NDC 0009-3359
Product ID 0009-3359_e72f678f-ff11-47d7-94ea-186113ec3fbd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019617
Listing Expiration 2026-12-31
Marketing Start 1992-12-09

Pharmacologic Class

Established (EPC)
prostaglandin analog [epc]
Chemical Structure
prostaglandins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00093359
Hyphenated Format 0009-3359

Supplemental Identifiers

RxCUI
208397 309922
UPC
0300093359024
UNII
K7Q1JQR04M
NUI
N0000175454 M0017805

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name prepidil (source: ndc)
Generic Name dinoprostone (source: ndc)
Application Number NDA019617 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/3g
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (0009-3359-01) / 3 g in 1 SYRINGE
source: ndc

Packages (1)

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

Ingredients (1)

dinoprostone (.5 mg/3g)

Linked Drug Pages (1)

Prepidil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "e72f678f-ff11-47d7-94ea-186113ec3fbd", "openfda": {"nui": ["N0000175454", "M0017805"], "upc": ["0300093359024"], "unii": ["K7Q1JQR04M"], "rxcui": ["208397", "309922"], "spl_set_id": ["ab03de5b-782c-4f81-a8dc-7ef9969dd0cf"], "pharm_class_cs": ["Prostaglandins [CS]"], "pharm_class_epc": ["Prostaglandin Analog [EPC]"], "manufacturer_name": ["Pharmacia & Upjohn Company LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (0009-3359-01)  / 3 g in 1 SYRINGE", "package_ndc": "0009-3359-01", "marketing_start_date": "20191211"}], "brand_name": "Prepidil", "product_id": "0009-3359_e72f678f-ff11-47d7-94ea-186113ec3fbd", "dosage_form": "GEL", "pharm_class": ["Prostaglandin Analog [EPC]", "Prostaglandins [CS]"], "product_ndc": "0009-3359", "generic_name": "dinoprostone", "labeler_name": "Pharmacia & Upjohn Company LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prepidil", "active_ingredients": [{"name": "DINOPROSTONE", "strength": ".5 mg/3g"}], "application_number": "NDA019617", "marketing_category": "NDA", "marketing_start_date": "19921209", "listing_expiration_date": "20261231"}