NDC 0456-1201

Linzess

Linaclotide

Linzess is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Linaclotide.

Product ID0456-1201_114152bc-d286-4228-9b01-9814473d3875
NDC0456-1201
Product TypeHuman Prescription Drug
Proprietary NameLinzess
Generic NameLinaclotide
Dosage FormCapsule, Gelatin Coated
Route of AdministrationORAL
Marketing Start Date2012-09-08
Marketing CategoryNDA / NDA
Application NumberNDA202811
Labeler NameAllergan, Inc.
Substance NameLINACLOTIDE
Active Ingredient Strength145 ug/1
Pharm ClassesGuanylate Cyclase-C Agonist [EPC],Guanylate Cyclase Activators [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0456-1201-04

1 BOTTLE in 1 CARTON (0456-1201-04) > 4 CAPSULE, GELATIN COATED in 1 BOTTLE
Marketing Start Date2012-09-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0456-1201-04 [00456120104]

Linzess CAPSULE, GELATIN COATED
Marketing CategoryNDA
Application NumberNDA202811
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-09-08

NDC 0456-1201-30 [00456120130]

Linzess CAPSULE, GELATIN COATED
Marketing CategoryNDA
Application NumberNDA202811
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-09-08

Drug Details

Active Ingredients

IngredientStrength
LINACLOTIDE145 ug/1

OpenFDA Data

SPL SET ID:09beda19-56d6-4a56-afdc-9a77b70b2ef3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1869699
  • 1307415
  • 1307421
  • 1307409
  • 1307419
  • 1869697
  • UPC Code
  • 0304561203307
  • 0304561201303
  • 0304561202300
  • Pharmacological Class

    • Guanylate Cyclase-C Agonist [EPC]
    • Guanylate Cyclase Activators [MoA]
    • Guanylate Cyclase-C Agonist [EPC]
    • Guanylate Cyclase Activators [MoA]

    NDC Crossover Matching brand name "Linzess" or generic name "Linaclotide"

    NDCBrand NameGeneric Name
    0456-1201Linzesslinaclotide
    0456-1202Linzesslinaclotide
    0456-1203Linzesslinaclotide

    Trademark Results [Linzess]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LINZESS
    LINZESS
    85773175 4614364 Live/Registered
    Ironwood Pharmaceuticals, Inc.
    2012-11-06
    LINZESS
    LINZESS
    77872111 4328588 Live/Registered
    Ironwood Pharmaceuticals, Inc.
    2009-11-13

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