Ursodiol tablet, film coated

Ingredients and appearance - Product information

Ursodiol tablet, film coated- Ursodiol

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68001-343
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ursodiol ( UNII: 724L30Y2QR)( Ursodiol - UNII: 724L30Y2QR ) 250 mgin 1

Inactive Ingredients

Ingredient Name Code
Microcrystalline cellulose ( UNII: OP1R32D61U)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Povidone, unspecified ( UNII: FZ989GH94E)
Magnesium stearate ( UNII: 70097M6I30)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Titanium dioxide ( UNII: 15FIX9V2JP)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Polyethylene glycol 400 ( UNII: B697894SGQ)

Product Characteristics

Color WHITE Size 15 mm
Shape OVAL (biconvex) Score 1
Imprint Code IX524

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA200826 USA

Ursodiol tablet, film coated- Ursodiol

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68001-344
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ursodiol ( UNII: 724L30Y2QR)( Ursodiol - UNII: 724L30Y2QR ) 500 mgin 1

Inactive Ingredients

Ingredient Name Code
Microcrystalline cellulose ( UNII: OP1R32D61U)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Povidone, unspecified ( UNII: FZ989GH94E)
Magnesium stearate ( UNII: 70097M6I30)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Titanium dioxide ( UNII: 15FIX9V2JP)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Polyethylene glycol 400 ( UNII: B697894SGQ)

Product Characteristics

Color WHITE Size 18 mm
Shape OVAL (biconvex) Score 2
Imprint Code IX525

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA200826 USA

Labeler - BluePoint Laboratories( 985523874)

Establishment

Name ID/FEI Business Operations
BluePoint Laboratories 985523874 ANALYSIS( 68001-343, 68001-344), LABEL( 68001-343, 68001-344), MANUFACTURE( 68001-343, 68001-344), PACK( 68001-343, 68001-344)

Package/label principal display panel

Ursodiol Tablets USP, 250 mg, 100 Tablets

NDC 68001-343-00

Package/label display panel

Ursodiol Tablets USP, 250 mg, 100 Tablets

NDC 68001-344-00