Ursodiol 200 mg
Ursodiol Capsules, USP Rx Only
Approved
Approval ID
ebaaa3e2-1d80-4b40-b696-88cdd06448e4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 13, 2020
Manufacturers
FDA
LGM Pharma Solutions, LLC
DUNS: 117549198
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Usodiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code79739-7143
Application NumberANDA205789
Product Classification
M
Marketing Category
C73584
G
Generic Name
Usodiol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 13, 2020
FDA Product Classification
INGREDIENTS (6)
URSODIOLActive
Quantity: 200 mg in 1 1
Code: 724L30Y2QR
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Usodiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code79739-7144
Application NumberANDA205789
Product Classification
M
Marketing Category
C73584
G
Generic Name
Usodiol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 13, 2020
FDA Product Classification
INGREDIENTS (7)
URSODIOLActive
Quantity: 400 mg in 1 1
Code: 724L30Y2QR
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT