Ursodiol 200 mg
Ursodiol Capsules, USP Rx Only
Approved
Approval ID
476179dc-b410-4305-881b-470511765647
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2023
Manufacturers
FDA
FH2 Pharma LLC
DUNS: 116969558
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ursodiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72887-144
Application NumberANDA205789
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ursodiol
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 14, 2022
FDA Product Classification
INGREDIENTS (7)
URSODIOLActive
Quantity: 400 mg in 1 1
Code: 724L30Y2QR
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Ursodiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72887-143
Application NumberANDA205789
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ursodiol
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 14, 2022
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
URSODIOLActive
Quantity: 200 mg in 1 1
Code: 724L30Y2QR
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT