NDC 0456-1203

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 ID: 0456-1203_114152bc-d286-4228-9b01-9814473d3875
• NDC: 0456-1203
• Product Type: Human Prescription Drug
• Proprietary Name: Linzess
• Generic Name: Linaclotide
• Dosage Form: Capsule, Gelatin Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-01-30
• Marketing Category: NDA / NDA
• Application Number: NDA202811
• Labeler Name: Allergan, Inc.
• Substance Name: LINACLOTIDE
• Active Ingredient Strength: 72 ug/1
• Pharm Classes: Guanylate Cyclase-C Agonist [EPC],Guanylate Cyclase Activators [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0456-1203-04

1 BOTTLE in 1 CARTON (0456-1203-04) > 4 CAPSULE, GELATIN COATED in 1 BOTTLE

• Marketing Start Date: 2017-01-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0456-1203-30 [00456120330]

Linzess CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA202811
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-01-30

NDC 0456-1203-04 [00456120304]

Linzess CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA202811
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-01-30

Drug Details

Active Ingredients

Ingredient	Strength
LINACLOTIDE	72 ug/1

OpenFDA Data

• SPL SET ID: 09beda19-56d6-4a56-afdc-9a77b70b2ef3
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • N0TXR0XR5X
• 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"

NDC	Brand Name	Generic Name
0456-1201	Linzess	linaclotide
0456-1202	Linzess	linaclotide
0456-1203	Linzess	linaclotide