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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69387-101
Application NumberANDA200900
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROGESTERONE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2015
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69387-102
Application NumberANDA200900
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROGESTERONE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2015
FDA Product Classification
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