Ursodiol
Ursodiol Capsules USP, 300 mg
Approved
Approval ID
d58f4da2-bc59-4bf3-b851-1fdb73b8cccd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
TAGI Pharma, Inc.
DUNS: 963322560
Products 1
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 Code51224-151
Application NumberANDA075517
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ursodiol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (14)
UrsodiolActive
Quantity: 300 mg in 1 1
Code: 724L30Y2QR
Classification: ACTIB
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C blue NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
FD&C red NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C yellow NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C Blue NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C red NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT