Prepidil
Prepidil Gel dinoprostone cervical gel
Approved
Approval ID
ab03de5b-782c-4f81-a8dc-7ef9969dd0cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2019
Manufacturers
FDA
Pharmacia and Upjohn Company LLC
DUNS: 618054084
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dinoprostone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0009-3359
Application NumberNDA019617
Product Classification
M
Marketing Category
C73594
G
Generic Name
dinoprostone
Product Specifications
Route of AdministrationVAGINAL
Effective DateDecember 11, 2019
FDA Product Classification
INGREDIENTS (3)
DINOPROSTONEActive
Quantity: 0.5 mg in 3 g
Code: K7Q1JQR04M
Classification: ACTIB
SILICON DIOXIDEInactive
Quantity: 240 mg in 3 g
Code: ETJ7Z6XBU4
Classification: IACT
TRIACETINInactive
Quantity: 2760 mg in 3 g
Code: XHX3C3X673
Classification: IACT