Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Pharmacia and Upjohn Company LLC
Pharmacia and Upjohn Company LLC
618054084
Pfizer Manufacturing Belgium NV
Pharmacia and Upjohn Company LLC
370156507
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prepidil
Product Details
NDC Product Code
0009-3359Application Number
NDA019617Marketing Category
NDA (C73594)Route of Administration
VAGINALEffective Date
December 11, 2019Prostaglandin E2Active
Code: K7Q1JQR04MClass: ACTIBQuantity: 0.5 mg in 3 g
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACTQuantity: 240 mg in 3 g
TRIACETINInactive
Code: XHX3C3X673Class: IACTQuantity: 2760 mg in 3 g