linzess

Generic: linaclotide

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name linzess
Generic Name linaclotide
Labeler allergan, inc.
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

linaclotide 290 ug/1

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0456-1202
Product ID 0456-1202_7d31ab60-8fd1-4502-8ff5-33586d9772d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202811
Listing Expiration 2027-12-31
Marketing Start 2012-09-08

Pharmacologic Class

Established (EPC)
guanylate cyclase-c agonist [epc]
Mechanism of Action
guanylate cyclase activators [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04561202
Hyphenated Format 0456-1202

Supplemental Identifiers

RxCUI
1307409 1307415 1307419 1307421 1869697 1869699
UPC
0304561203307 0304561202300 0304561201303
UNII
N0TXR0XR5X
NUI
N0000185500 N0000185499

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name linzess (source: ndc)
Generic Name linaclotide (source: ndc)
Application Number NDA202811 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 290 ug/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0456-1202-04) / 4 CAPSULE, GELATIN COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0456-1202-07) / 7 CAPSULE, GELATIN COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0456-1202-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE
source: ndc

Packages (3)

0456-1202-04 1 BOTTLE in 1 CARTON (0456-1202-04) / 4 CAPSULE, GELATIN COATED in 1 BOTTLE 0456-1202-07 1 BOTTLE in 1 CARTON (0456-1202-07) / 7 CAPSULE, GELATIN COATED in 1 BOTTLE 0456-1202-30 1 BOTTLE in 1 CARTON (0456-1202-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE

Ingredients (1)

linaclotide (290 ug/1)

Linked Drug Pages (1)

Linzess ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7d31ab60-8fd1-4502-8ff5-33586d9772d6", "openfda": {"nui": ["N0000185500", "N0000185499"], "upc": ["0304561203307", "0304561202300", "0304561201303"], "unii": ["N0TXR0XR5X"], "rxcui": ["1307409", "1307415", "1307419", "1307421", "1869697", "1869699"], "spl_set_id": ["09beda19-56d6-4a56-afdc-9a77b70b2ef3"], "pharm_class_epc": ["Guanylate Cyclase-C Agonist [EPC]"], "pharm_class_moa": ["Guanylate Cyclase Activators [MoA]"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE in 1 CARTON (0456-1202-04)  / 4 CAPSULE, GELATIN COATED in 1 BOTTLE", "package_ndc": "0456-1202-04", "marketing_start_date": "20120908"}, {"sample": true, "description": "1 BOTTLE in 1 CARTON (0456-1202-07)  / 7 CAPSULE, GELATIN COATED in 1 BOTTLE", "package_ndc": "0456-1202-07", "marketing_start_date": "20190517"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0456-1202-30)  / 30 CAPSULE, GELATIN COATED in 1 BOTTLE", "package_ndc": "0456-1202-30", "marketing_start_date": "20120908"}], "brand_name": "Linzess", "product_id": "0456-1202_7d31ab60-8fd1-4502-8ff5-33586d9772d6", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Guanylate Cyclase Activators [MoA]", "Guanylate Cyclase-C Agonist [EPC]"], "product_ndc": "0456-1202", "generic_name": "linaclotide", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Linzess", "active_ingredients": [{"name": "LINACLOTIDE", "strength": "290 ug/1"}], "application_number": "NDA202811", "marketing_category": "NDA", "marketing_start_date": "20120908", "listing_expiration_date": "20271231"}