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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

631339fc-548d-4cd5-8cf3-60e1590f79f6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 7, 2023

Manufacturers
FDA

Aurobindo Pharma Limited

DUNS: 650082092

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 Code59651-421
Application NumberANDA214849
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ursodiol
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 7, 2023
FDA Product Classification

INGREDIENTS (10)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
URSODIOLActive
Quantity: 300 mg in 1 1
Code: 724L30Y2QR
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/7/2023

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 300 mg (100 Capsules Bottle)

NDC 59651-421-01


** Rx only**
** Ursodiol Capsules, USP**
** 300 mg**

AUROBINDO 100 Capsules


****PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 300 mg (100 Capsules Bottle)

DESCRIPTION SECTION

LOINC: 34089-3Updated: 9/7/2023

DESCRIPTION

Ursodiol capsules, USP are a bile acid available as 300 mg capsules suitable for oral administration.

Ursodiol USP (ursodeoxycholic acid), a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white or almost white crystalline powder practically insoluble in water; freely soluble in ethanol (96 percent), slightly soluble in acetone, practically insoluble in methylene chloride. The chemical name for ursodiol is 3α,7β-dihydroxy-5β-cholan-24-oic acid (C24H40O4). Ursodiol USP has a molecular weight of 392.58. Its structure is shown below:

chemical structer

Inactive Ingredients: Colloidal silicon dioxide, corn starch and magnesium stearate. The hard gelatin capsule shells contain gelatin, iron oxide red and titanium dioxide. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide and shellac.

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Ursodiol - FDA Drug Approval Details