Progesterone
Progesterone, USP
Approved
Approval ID
2fac2189-5d9d-4408-a1cf-b6bbdf643adc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 19, 2020
Manufacturers
FDA
Virtus Pharmaceuticals
DUNS: 079659493
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 Code69543-375
Application NumberNDA019781
Product Classification
M
Marketing Category
C73594
G
Generic Name
Progesterone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2018
FDA Product Classification
INGREDIENTS (8)
PROGESTERONEActive
Quantity: 200 mg in 1 1
Code: 4G7DS2Q64Y
Classification: ACTIB
PEANUT OILInactive
Code: 5TL50QU0W4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Progesterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69543-374
Application NumberNDA019781
Product Classification
M
Marketing Category
C73594
G
Generic Name
Progesterone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2018
FDA Product Classification
INGREDIENTS (8)
PROGESTERONEActive
Quantity: 100 mg in 1 1
Code: 4G7DS2Q64Y
Classification: ACTIB
PEANUT OILInactive
Code: 5TL50QU0W4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT