PROGESTERONE
Approved
Approval ID
d8925bba-f002-4455-a28f-eb6a888b4fe6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2015
Manufacturers
FDA
Banner Life Sciences LLC.
DUNS: 079579273
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PROGESTERONE
PRODUCT DETAILS
NDC Product Code69387-101
Application NumberANDA200900
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 30, 2015
Generic NamePROGESTERONE
INGREDIENTS (8)
PROGESTERONEActive
Quantity: 100 mg in 1 1
Code: 4G7DS2Q64Y
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
PEANUT OILInactive
Code: 5TL50QU0W4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROGESTERONE
PRODUCT DETAILS
NDC Product Code69387-102
Application NumberANDA200900
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 30, 2015
Generic NamePROGESTERONE
INGREDIENTS (7)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROGESTERONEActive
Quantity: 200 mg in 1 1
Code: 4G7DS2Q64Y
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
PEANUT OILInactive
Code: 5TL50QU0W4
Classification: IACT