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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76420-059
Application NumberANDA207724
Product Classification
M
Marketing Category
C73584
G
Generic Name
Progesterone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76420-058
Application NumberANDA207724
Product Classification
M
Marketing Category
C73584
G
Generic Name
Progesterone
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2022
FDA Product Classification
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