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NDC 65649-0003-03 Trulance 3 mg/1 Details
Trulance 3 mg/1
Trulance is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Salix Pharmaceuticals Inc.. The primary component is PLECANATIDE.
MedlinePlus Drug Summary
Plecanatide is used in adults to treat 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) and irritable bowel syndrome with constipation (IBS-C; a condition that causes stomach pain or cramps, bloating, and constipation.) Plecanatide 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: 65649-0003-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Plecanatide
Product Information
| NDC | 65649-0003 |
|---|---|
| Product ID | 65649-003_e757981c-c4fc-4702-83ee-0d90382fb959 |
| Associated GPIs | 52543060000320 |
| GCN Sequence Number | 077047 |
| GCN Sequence Number Description | plecanatide TABLET 3 MG ORAL |
| HIC3 | D6G |
| HIC3 Description | IBS-C/CIC AGENTS, GUANYLATE CYCLASE-C AGONIST |
| GCN | 42925 |
| HICL Sequence Number | 044054 |
| HICL Sequence Number Description | PLECANATIDE |
| Brand/Generic | Brand |
| Proprietary Name | Trulance |
| Proprietary Name Suffix | Immediate release |
| Non-Proprietary Name | Plecanatide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 3 |
| Active Ingredient Units | mg/1 |
| Substance Name | PLECANATIDE |
| Labeler Name | Salix Pharmaceuticals Inc. |
| Pharmaceutical Class | Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208745 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65649-0003-03 (65649000303)
| NDC Package Code | 65649-003-03 |
|---|---|
| Billing NDC | 65649000303 |
| Package | 1 BOTTLE in 1 CARTON (65649-003-03) / 3 TABLET in 1 BOTTLE |
| Marketing Start Date | 2017-02-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |