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Soriatane

Generic Name: acitretin
Dosage Form: capsule

Medically reviewed on Nov 1, 2017

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See also: Stelara

NDC 0145-0090-25

Soriatane®

(acitretin) Capsules

10 mg

30 Capsules

Rx only

CAUSES BIRTH DEFECTS

DO NOT GET PREGNANT

Made in Austria

©2016 Stiefel Laboratories, Inc.

 
10000000140426 Rev. 3/16

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NDC 0145-3187-03

Soriatane®

(acitretin) Capsules

17.5 mg

30 Capsules

Rx only

CAUSES BIRTH DEFECTS

DO NOT GET PREGNANT

Made in Austria

©2016 Stiefel Laboratories, Inc.

 
10000000140427 Rev. 3/16

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NDC 0145-0091-25

Soriatane®

(acitretin) Capsules

25 mg

30 Capsules

Rx only

CAUSES BIRTH DEFECTS

DO NOT GET PREGNANT

Made in Austria

©2016 Stiefel Laboratories, Inc.

 
10000000140428 Rev. 3/16
Soriatane 
acitretin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:12064-006
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACITRETIN (ACITRETIN) ACITRETIN 10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE  
SODIUM ASCORBATE  
GELATIN, UNSPECIFIED  
MALTODEXTRIN  
FERRIC OXIDE YELLOW  
FERROSOFERRIC OXIDE  
FERRIC OXIDE RED  
TITANIUM DIOXIDE  
Product Characteristics
Color BROWN, WHITE Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code A;10;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:12064-006-00 30 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA019821 11/01/1996
Soriatane 
acitretin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:12064-007
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACITRETIN (ACITRETIN) ACITRETIN 17.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE  
SODIUM ASCORBATE  
GELATIN, UNSPECIFIED  
MALTODEXTRIN  
FERRIC OXIDE YELLOW  
FERROSOFERRIC OXIDE  
FERRIC OXIDE RED  
TITANIUM DIOXIDE  
Product Characteristics
Color YELLOW (rich yellow) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code A;17;5;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:12064-007-00 30 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA019821 01/04/2010
Soriatane 
acitretin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:12064-008
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACITRETIN (ACITRETIN) ACITRETIN 25 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE  
SODIUM ASCORBATE  
GELATIN, UNSPECIFIED  
MALTODEXTRIN  
FERRIC OXIDE YELLOW  
FERROSOFERRIC OXIDE  
FERRIC OXIDE RED  
TITANIUM DIOXIDE  
Product Characteristics
Color BROWN, YELLOW Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code A;25;mg
Contains     
Packaging
# Item Code Package Description
1 NDC:12064-008-00 30 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Approved Drug Product Manufactured Under Contract NDA019821 11/01/1996
Labeler - GlaxoSmithKline Manufacturing SpA (338471078)
 
GlaxoSmithKline Manufacturing SpA
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