Ursodiol 200 Mg (Page 4 of 4)

OVERDOSAGE

Neither accidental nor intentional overdosing with ursodiol has been reported. Doses of ursodiol in the range of 16-20 mg/kg/day have been tolerated for 6 to 37 months without symptoms by 7 patients. The LD50 for ursodiol in rats is over 5000 mg/kg given over 7 to 10 days and over 7500 mg/kg for mice. The most likely manifestation of severe overdose with ursodiol would probably be diarrhea, which should be treated symptomatically.

DOSAGE AND ADMINISTRATION

Gallstone Dissolution

The recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8-10 mg/kg/day given in 2 or 3 divided doses.

Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.

Gallstone Prevention

The recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day.

HOW SUPPLIED

Ursodiol Capsules, USP 200 mg are opaque white capsules imprinted with a thick black bar.
Ursodiol Capsules, USP 400 mg are opaque yellow and white capsules imprinted with a thick black bar.

Bottles of 100 are supplied with child-resistant closures.
Ursodiol Capsules, USP 200 mg (NDC 0722-7143-01)

Ursodiol Capsules, USP 400 mg (NDC 0722-7144-01)

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

Dispense in tight container (USP).

Rx only

Keep out of reach of children.

Manufactured By:
Nexgen Pharma, Inc.
Irvine, CA 92606

Revised: 05/2020

Package/Label Display Panel

Ursodiol Capsules, USP 200mg (NDC 0722-7143-01) 100 Capsules

Ursodiol Capsules, USP 200mg Container Label
(click image for full-size original)

Package/Label Display Panel

Ursodiol Capsules, USP 400mg (NDC 0722-7144-01) 100 Capsules

Ursodiol Capsules, USP 400mg Container Label
(click image for full-size original)
URSODIOL 200 MG
usodiol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0722-7143
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
URSODIOL (URSODIOL) URSODIOL 200 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
Product Characteristics
Color WHITE (White Cap) Score no score
Shape CAPSULE (White Body) Size 18mm
Flavor Imprint Code Thick;Black;Bar
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0722-7143-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205789 07/01/2020
URSODIOL 400 MG
usodiol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0722-7144
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
URSODIOL (URSODIOL) URSODIOL 400 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
D&C YELLOW NO. 10
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
Product Characteristics
Color WHITE (Yellow Cap) Score no score
Shape CAPSULE (White Body) Size 22mm
Flavor Imprint Code Thick;Black;Bar
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0722-7144-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205789 07/01/2020
Labeler — Nexgen Pharma, Inc (048488621)
Registrant — Nexgen Pharma, Inc. (048488621)
Establishment
Name Address ID/FEI Operations
Nexgen Pharma, Inc. 160356114 MANUFACTURE (0722-7143), MANUFACTURE (0722-7144), ANALYSIS (0722-7143), ANALYSIS (0722-7144), PACK (0722-7143), PACK (0722-7144), LABEL (0722-7143), LABEL (0722-7144)

Revised: 05/2020 Nexgen Pharma, Inc

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