Itraconazole capsule

Ingredients and appearance - Product information

Itraconazole capsule- Itraconazole

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50268-450
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Itraconazole ( UNII: 304NUG5GF4)( Itraconazole - UNII: 304NUG5GF4 ) 100 mgin 1

Inactive Ingredients

Ingredient Name Code
Ferrosoferric oxide ( UNII: XM0M87F357)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Gelatin ( UNII: 2G86QN327L)
Hypromelloses ( UNII: 3NXW29V3WO)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Potassium hydroxide ( UNII: WZH3C48M4T)
Propylene glycol ( UNII: 6DC9Q167V3)
Shellac ( UNII: 46N107B71O)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Starch, corn ( UNII: O8232NY3SJ)
Ammonia ( UNII: 5138Q19F1X)
Sucrose ( UNII: C151H8M554)
Titanium dioxide ( UNII: 15FIX9V2JP)
Dextrose ( UNII: IY9XDZ35W2)

Product Characteristics

Color blue (opaque) Imprint Code AMNEAL;630
Score 1 Shape CAPSULE
Size 22 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA205080 USA

Labeler - AvPAK( 832926666)