Search by Drug Name or NDC
NDC 00456-1202-04 Linzess 290 ug/1 Details
Linzess 290 ug/1
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.
MedlinePlus Drug Summary
Linaclotide is used in adults to treat irritable bowel syndrome with constipation (IBS-C; a condition that causes stomach pain or cramps, bloating, and infrequent or difficult passage of stools) and chronic idiopathic constipation (CIC; difficult or infrequent passage of stools that lasts for 3 months or longer and is not caused by a disease or a medication). Linaclotide is in a class of medications called guanylate cyclase-C agonists. It works by increasing the movement of food and waste through the stomach and intestines.
Related Packages: 00456-1202-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Linaclotide
Product Information
| NDC | 00456-1202 |
|---|---|
| Product ID | 0456-1202_e471953e-5cf7-45b5-ae6f-e6e8a75087ea |
| Associated GPIs | 52557050000140 |
| GCN Sequence Number | 069923 |
| GCN Sequence Number Description | linaclotide CAPSULE 290 MCG ORAL |
| HIC3 | D6G |
| HIC3 Description | IBS-C/CIC AGENTS, GUANYLATE CYCLASE-C AGONIST |
| GCN | 33188 |
| HICL Sequence Number | 039583 |
| HICL Sequence Number Description | LINACLOTIDE |
| Brand/Generic | Brand |
| Proprietary Name | Linzess |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | linaclotide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, GELATIN COATED |
| Route | ORAL |
| Active Ingredient Strength | 290 |
| Active Ingredient Units | ug/1 |
| Substance Name | LINACLOTIDE |
| Labeler Name | Allergan, Inc. |
| Pharmaceutical Class | Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA202811 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00456-1202-04 (00456120204)
| NDC Package Code | 0456-1202-04 |
|---|---|
| Billing NDC | 00456120204 |
| Package | 1 BOTTLE in 1 CARTON (0456-1202-04) / 4 CAPSULE, GELATIN COATED in 1 BOTTLE |
| Marketing Start Date | 2012-09-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |