LINZESS
linaclotide capsule, gelatin coated
Product Information
Product Type
HUMAN PRESCRIPTION DRUG
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
Multilevel Packaging
1
NDC:0456-1201-30
1 BOTTLE (1 BOTTLE) in 1 CARTON
contains a BOTTLE
1
30 CAPSULE, GELATIN COATED (30 CAPSULE) in 1 BOTTLE
This package is contained within the CARTON (0456-1201-30)
2
NDC:0456-1201-04
1 BOTTLE (1 BOTTLE) in 1 CARTON
contains a BOTTLE
2
4 CAPSULE, GELATIN COATED (4 CAPSULE) in 1 BOTTLE
This package is contained within the CARTON (0456-1201-04)
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
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
Multilevel Packaging
1NDC:0456-1202-30
1 BOTTLE (1 BOTTLE) in 1 CARTON
contains a BOTTLE
130 CAPSULE, GELATIN COATED (30 CAPSULE) in 1 BOTTLE
This package is contained within the CARTON (0456-1202-30)
2NDC:0456-1202-04
1 BOTTLE (1 BOTTLE) in 1 CARTON
contains a BOTTLE
24 CAPSULE, GELATIN COATED (4 CAPSULE) in 1 BOTTLE
This package is contained within the CARTON (0456-1202-04)
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
Operations
Anderson Packaging, Inc.
053217022
REPACK, REPACK
Establishment
Name
Address
ID/FEI
Operations
Corden Pharma Colorado, Inc.
076470525
API MANUFACTURE, API MANUFACTURE
Establishment
Name
Address
ID/FEI
Operations
Forest Lab
