Acitretin capsule

Ingredients and appearance - Product information

Acitretin capsule- Acitretin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0115-1750
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acitretin ( UNII: LCH760E9T7)( Acitretin - UNII: LCH760E9T7 ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Maltodextrin ( UNII: 7CVR7L4A2D)
Sodium ascorbate ( UNII: S033EH8359)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Gelatin ( UNII: 2G86QN327L)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Titanium dioxide ( UNII: 15FIX9V2JP)
Ferric oxide red ( UNII: 1K09F3G675)
Shellac ( UNII: 46N107B71O)
Ferrosoferric oxide ( UNII: XM0M87F357)
Propylene glycol ( UNII: 6DC9Q167V3)

Product Characteristics

Color BROWN (brown cap) Imprint Code IX;667
Score 1 Shape CAPSULE
Size 14 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0115-1750-08 30 in 1 BOTTLE, PLASTIC 2016/01/04

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202552 USA 2016/01/04

Acitretin capsule- Acitretin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0115-1751
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acitretin ( UNII: LCH760E9T7)( Acitretin - UNII: LCH760E9T7 ) 17.5 mgin 1

Inactive Ingredients

Ingredient Name Code
Maltodextrin ( UNII: 7CVR7L4A2D)
Sodium ascorbate ( UNII: S033EH8359)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Gelatin ( UNII: 2G86QN327L)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Titanium dioxide ( UNII: 15FIX9V2JP)
Ferric oxide yellow ( UNII: EX438O2MRT)
Shellac ( UNII: 46N107B71O)
Ferrosoferric oxide ( UNII: XM0M87F357)
Propylene glycol ( UNII: 6DC9Q167V3)

Product Characteristics

Color YELLOW (yellow to light yellow) Imprint Code IX;668
Score 1 Shape CAPSULE
Size 18 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0115-1751-08 30 in 1 BOTTLE, PLASTIC 2016/01/04

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202552 USA 2016/01/04

Acitretin capsule- Acitretin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0115-1752
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acitretin ( UNII: LCH760E9T7)( Acitretin - UNII: LCH760E9T7 ) 22.5 mgin 1

Inactive Ingredients

Ingredient Name Code
Maltodextrin ( UNII: 7CVR7L4A2D)
Sodium ascorbate ( UNII: S033EH8359)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Gelatin ( UNII: 2G86QN327L)
Ferric oxide red ( UNII: 1K09F3G675)
Shellac ( UNII: 46N107B71O)
Ferrosoferric oxide ( UNII: XM0M87F357)
Propylene glycol ( UNII: 6DC9Q167V3)

Product Characteristics

Color BROWN Imprint Code IX;698
Score 1 Shape CAPSULE
Size 19 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0115-1752-08 30 in 1 BOTTLE, PLASTIC 2016/01/04

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202552 USA 2016/01/04

Acitretin capsule- Acitretin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0115-1753
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acitretin ( UNII: LCH760E9T7)( Acitretin - UNII: LCH760E9T7 ) 25 mgin 1

Inactive Ingredients

Ingredient Name Code
Maltodextrin ( UNII: 7CVR7L4A2D)
Sodium ascorbate ( UNII: S033EH8359)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Gelatin ( UNII: 2G86QN327L)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Titanium dioxide ( UNII: 15FIX9V2JP)
Ferric oxide red ( UNII: 1K09F3G675)
Ferric oxide yellow ( UNII: EX438O2MRT)
Shellac ( UNII: 46N107B71O)
Ferrosoferric oxide ( UNII: XM0M87F357)
Propylene glycol ( UNII: 6DC9Q167V3)

Product Characteristics

Color BROWN (brown cap) Imprint Code IX;669
Score 1 Shape CAPSULE
Size 19 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0115-1753-08 30 in 1 BOTTLE, PLASTIC 2016/01/04

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202552 USA 2016/01/04

Labeler - Amneal Pharmaceuticals of New York LLC( 123797875)