Ursodiol
Ursodiol Capsules USP Rx only
Approved
Approval ID
db43354d-4d77-4241-af4e-5cfa6f6cd296
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 25, 2023
Manufacturers
FDA
VGYAAN Pharmaceuticals LLC
DUNS: 024755855
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 Code72664-217
Application NumberANDA214329
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ursodiol
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
URSODIOLActive
Quantity: 300 mg in 1 1
Code: 724L30Y2QR
Classification: ACTIB