Linzess (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

NDC 0456-1203-30
Rx Only
30 CAPSULES
Linzess
(linaclotide) capsules72 mcg/capsule

PRINCIPAL DISPLAY PANEL
NDC 0456-1203-30
Rx Only
30 CAPSULES
Linzess
(linaclotide) capsules
72 mcg/capsule
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0456-1201-30
Rx Only
30 CAPSULES
Linzess
(linaclotide) capsules145 mcg/capsule

PRINCIPAL DISPLAY PANEL
NDC 0456-1201-30
Rx Only
30 CAPSULES
Linzess
(linaclotide) capsules
145 mcg/capsule
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0456-1202-30
Rx Only
30 CAPSULES
Linzess
(linaclotide) capsules290 mcg/capsule

PRINCIPAL DISPLAY PANEL
NDC 0456-1202-30
Rx Only
30 CAPSULES
Linzess
(linaclotide) capsules
290 mcg/capsule
(click image for full-size original)

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
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
HYPROMELLOSE, UNSPECIFIED
GELATIN, UNSPECIFIED
Product Characteristics
Color white (white) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code FL;145
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0456-1201-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 CAPSULE, GELATIN COATED in 1 BOTTLE This package is contained within the CARTON (0456-1201-30)
2 NDC:0456-1201-04 1 BOTTLE in 1 CARTON contains a BOTTLE
2 4 CAPSULE, GELATIN COATED 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
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
Product Characteristics
Color white (white) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code FL;290
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0456-1202-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 CAPSULE, GELATIN COATED in 1 BOTTLE This package is contained within the CARTON (0456-1202-30)
2 NDC:0456-1202-04 1 BOTTLE in 1 CARTON contains a BOTTLE
2 4 CAPSULE, GELATIN COATED 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
LINZESS linaclotide capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0456-1203
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LINACLOTIDE (LINACLOTIDE) LINACLOTIDE 72 ug
Inactive Ingredients
Ingredient Name Strength
CALCIUM CHLORIDE
HISTIDINE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
POWDERED CELLULOSE
CELLULOSE, MICROCRYSTALLINE
TITANIUM DIOXIDE
GELATIN, UNSPECIFIED
Product Characteristics
Color white (white) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code FL;72
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0456-1203-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 CAPSULE, GELATIN COATED in 1 BOTTLE This package is contained within the CARTON (0456-1203-30)
2 NDC:0456-1203-04 1 BOTTLE in 1 CARTON contains a BOTTLE
2 4 CAPSULE, GELATIN COATED in 1 BOTTLE This package is contained within the CARTON (0456-1203-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202811 01/30/2017
Labeler — Allergan, Inc. (144796497)

Revised: 08/2021 Allergan, Inc.

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