SORIATANE- acitretin capsule
GlaxoSmithKline Manufacturing SpA

----------

Principal Display Panel

NDC 0145-0090-25

SORIATANE®

(acitretin) Capsules

10 mg

30 Capsules

Rx only

CAUSES BIRTH DEFECTS

DO NOT GET PREGNANT

Made in Austria

: 10000000140426 Rev. 3/16

Principal Display Panel

NDC 0145-3187-03

SORIATANE®

(acitretin) Capsules

17.5 mg

30 Capsules

Rx only

CAUSES BIRTH DEFECTS

DO NOT GET PREGNANT

Made in Austria

: 10000000140427 Rev. 3/16

Principal Display Panel

NDC 0145-0091-25

SORIATANE®

(acitretin) Capsules

25 mg

30 Capsules

Rx only

CAUSES BIRTH DEFECTS

DO NOT GET PREGNANT

Made in Austria

: 10000000140428 Rev. 3/16

SORIATANE
acitretin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:12064-006
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACITRETIN (UNII: LCH760E9T7) (ACITRETIN - UNII:LCH760E9T7)	ACITRETIN	10 mg

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM ASCORBATE (UNII: S033EH8359)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN, WHITE	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	A;10;mg
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:12064-006-00	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/1996

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Approved Drug Product Manufactured Under Contract	NDA019821	11/01/1996

SORIATANE
acitretin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:12064-007
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACITRETIN (UNII: LCH760E9T7) (ACITRETIN - UNII:LCH760E9T7)	ACITRETIN	17.5 mg

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM ASCORBATE (UNII: S033EH8359)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW (rich yellow)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	A;17;5;mg
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:12064-007-00	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Approved Drug Product Manufactured Under Contract	NDA019821	01/04/2010

SORIATANE
acitretin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:12064-008
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACITRETIN (UNII: LCH760E9T7) (ACITRETIN - UNII:LCH760E9T7)	ACITRETIN	25 mg

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM ASCORBATE (UNII: S033EH8359)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN, YELLOW	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	A;25;mg
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:12064-008-00	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/1996

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Approved Drug Product Manufactured Under Contract	NDA019821	11/01/1996

Labeler - GlaxoSmithKline Manufacturing SpA (338471078)

Revised: 11/2017

Document Id: c9f7b714-1319-4e10-81ea-59fb494128cb

Set id: e2d73527-78f6-4638-82aa-6478f07c0318

Version: 2

Effective Time: 20171114

GlaxoSmithKline Manufacturing SpA