Progesterone
Progesterone Capsules (progesterone, USP), 100 mg and 200 mg
Approved
Approval ID
19716042-8025-43a3-b26d-e0fd7d2587eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2022
Manufacturers
FDA
Asclemed USA, Inc.
DUNS: 059888437
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 Code76420-059
Application NumberANDA207724
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 12, 2022
Generic NameProgesterone
INGREDIENTS (9)
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
PEANUT OILInactive
Code: 5TL50QU0W4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PROGESTERONEActive
Quantity: 200 mg in 1 1
Code: 4G7DS2Q64Y
Classification: ACTIB
Progesterone
PRODUCT DETAILS
NDC Product Code76420-058
Application NumberANDA207724
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 12, 2022
Generic NameProgesterone
INGREDIENTS (9)
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PEANUT OILInactive
Code: 5TL50QU0W4
Classification: IACT
PROGESTERONEActive
Quantity: 100 mg in 1 1
Code: 4G7DS2Q64Y
Classification: ACTIB