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Ursodiol

Ursodiol Capsules, USP Rx only Prescribing Information SPECIAL NOTE Gallbladder stone dissolution with ursodiol treatment requires months of therapy. Complete dissolution does not occur in all patients and recurrence of stones within 5 years has been observed in up to 50% of patients who do dissolve their stones on bile acid therapy. Patients should be carefully selected for therapy with ursodiol, and alternative therapies should be considered.

Approved
Approval ID

31ff3961-3ef1-4ec3-b742-beb4b96de795

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 5, 2023

Manufacturers
FDA

Chartwell RX, LLC

DUNS: 079394054

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 Code62135-430
Application NumberANDA213555
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ursodiol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification

INGREDIENTS (12)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
URSODIOLActive
Quantity: 300 mg in 1 1
Code: 724L30Y2QR
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT

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