Ursodiol 250 MG Oral Tablet
1 INDICATIONS AND USAGE Ursodiol tablets, 250 mg and 500 mg are indicated for the treatment of patients with primary biliary cholangitis (PBC). Ursodiol tablets, 250 mg and 500 mg are bile acids indicated for the treatment of patients with primary biliary cholangitis. ( 1 )
glenmark pharmaceuticals inc., usa
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ursodiol 500 MG Oral Tablet
glenmark pharmaceuticals inc., usa
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1
URSODIOL Tablets, USP 250 mg Each
URSODIOL Tablet, USP 250 mg is a white to off-white, oval shaped, film-coated tablet debossed with “G72” on one side and “250” on the other side and contains 250 mg
URSODIOL, USP.
URSODIOL Tablets, USP 250 mg are available in: Bottles of 30 tablets, NDC 68462-473-30 Bottles of 100 tablets, NDC 68462-473-01 Bottles of 500 tablets, NDC 68462-473-05 16.2
URSODIOL Tablets, USP 500 mg Each
URSODIOL Tablet, USP 500 mg is a white to off-white, oval shaped, film-coated tablet debossed with “U 11” on one side and a score line on the other side and contains 500 mg
URSODIOL, USP.
URSODIOL Tablets, USP 500 mg are available in: Bottles of 30 tablets, NDC 68462-474-30 Bottles of 100 tablets, NDC 68462-474-01 Bottles of 500 tablets, NDC 68462-474-05 Store at 20℃ to 25℃ (68℉ to 77℉) [see USP Controlled Room Temperature]. Dispense in a tight container. Half-tablets (scored
URSODIOL Tablets, USP 500 mg broken in half) maintain acceptable quality for up to 28 days when stored in the current packaging (bottles) at 20℃ to 25℃ (68℉ to 77℉). Due to the bitter taste, the halved segments should be stored separately from the whole tablets [see Dosage and Administration ( 2.3 )].
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