CERVIDIL
These highlights do not include all the information needed to use CERVIDIL safely and effectively. See full prescribing information for CERVIDIL. CERVIDIL (dinoprostone) vaginal insert Initial U.S. Approval: 1977
Approved
Approval ID
f3bc9031-0620-4a50-b440-f661cadfeb1d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 2, 2023
Manufacturers
FDA
Ferring Pharmaceuticals Inc.
DUNS: 103722955
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 Code55566-2800
Application NumberNDA020411
Product Classification
M
Marketing Category
C73594
G
Generic Name
DINOPROSTONE
Product Specifications
Route of AdministrationVAGINAL
Effective DateJanuary 31, 2020
FDA Product Classification
INGREDIENTS (2)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
DINOPROSTONEActive
Quantity: 10 mg in 241 mg
Code: K7Q1JQR04M
Classification: ACTIB