ENDOMETRIN
These highlights do not include all the information needed to use ENDOMETRIN safely and effectively. See full prescribing information for ENDOMETRIN. ENDOMETRIN (progesterone) Vaginal Insert 100 mg Initial U.S. Approval: 2007
Approved
Approval ID
2ba50fa9-b349-40cb-9a4b-1af8faa4ec09
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2022
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.
Progesterone
PRODUCT DETAILS
NDC Product Code55566-6500
Application NumberNDA022057
Marketing CategoryC73594
Route of AdministrationVAGINAL
Effective DateJanuary 31, 2018
Generic NameProgesterone
INGREDIENTS (9)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ADIPIC ACIDInactive
Code: 76A0JE0FKJ
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PROGESTERONEActive
Quantity: 100 mg in 1 1
Code: 4G7DS2Q64Y
Classification: ACTIB