Prometrium
PROMETRIUM (progesterone, USP)
Approved
Approval ID
a451784e-f6a0-414a-8409-3407f1d1d086
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2022
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 Code69543-373
Application NumberNDA019781
Product Classification
M
Marketing Category
C73594
G
Generic Name
Progesterone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2022
FDA Product Classification
INGREDIENTS (8)
PROGESTERONEActive
Quantity: 200 mg in 1 1
Code: 4G7DS2Q64Y
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PEANUT OILInactive
Code: 5TL50QU0W4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Progesterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69543-372
Application NumberNDA019781
Product Classification
M
Marketing Category
C73594
G
Generic Name
Progesterone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2022
FDA Product Classification
INGREDIENTS (8)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
PROGESTERONEActive
Quantity: 100 mg in 1 1
Code: 4G7DS2Q64Y
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
PEANUT OILInactive
Code: 5TL50QU0W4
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT