St. Louis, Missouri 63045

Ironwood

IRONWOD PHARMACEUTICALS

CAMBRIDGE MA 02142

 
LINZESS 
linaclotide capsule, gelatin coated 
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0456-1201
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
linaclotide (linaclotide)  linaclotide 145 ug
 
Inactive Ingredients
Ingredient Name Strength
calcium chloride  
Leucine  
hypromelloses  
cellulose, microcrystalline  
titanium dioxide  
gelatin  
 
Product Characteristics
Color white (white)  Score no score
Shape CAPSULE (CAPSULE)  Size 18mm
Flavor  Imprint Code FL;145 
Contains     
 
Packaging
# Item Code Package Description
1 NDC:0456-1201-30 1 in 1 CARTON
1  30 in 1 BOTTLE
2 NDC:0456-1201-04 1 in 1 CARTON
2  4 in 1 BOTTLE
 
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202811 09/08/2012 
 
LINZESS 
linaclotide capsule, gelatin coated 
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0456-1202
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
linaclotide (linaclotide)  linaclotide 290 ug
 
Inactive Ingredients
Ingredient Name Strength
calcium chloride  
Leucine  
hypromelloses  
cellulose, microcrystalline  
titanium dioxide  
gelatin  
 
Product Characteristics
Color white (white)  Score no score
Shape CAPSULE (CAPSULE)  Size 16mm
Flavor  Imprint Code FL;290 
Contains     
 
Packaging
# Item Code Package Description
1 NDC:0456-1202-30 1 in 1 CARTON
1  30 in 1 BOTTLE
2 NDC:0456-1202-04 1 in 1 CARTON
2  4 in 1 BOTTLE
 
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202811 09/08/2012 
 
Labeler - Forest Laboratories, Inc. (001288281) 
Establishment
Name Address ID/FEI Business Operations
Anderson Packaging, Inc.  053217022 REPACK(0456-1201, 0456-1202)
Establishment
Name Address ID/FEI Business Operations
Corden Pharma Colorado, Inc.  076470525 API MANUFACTURE(0456-1201, 0456-1202)
Establishment
Name Address ID/FEI Business Operations
Forest Laboratories, Inc.  932711815 ANALYSIS(0456-1201, 0456-1202)
Establishment
Name Address ID/FEI Business Operations
Forest Laboratories, Ireland, Ltd.  896303588 MANUFACTURE(0456-1201, 0456-1202), ANALYSIS(0456-1201, 0456-1202)
Establishment
Name Address ID/FEI Business Operations
Forest Pharmaceuticals, Inc.  13