trulance immediate release

Generic: plecanatide

Labeler: salix pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name trulance immediate release
Generic Name plecanatide
Labeler salix pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

plecanatide 3 mg/1

Manufacturer
Salix Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 65649-003
Product ID 65649-003_154842e6-a919-ba71-e063-6394a90aebd4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208745
Listing Expiration 2026-12-31
Marketing Start 2017-02-21

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 65649003
Hyphenated Format 65649-003

Supplemental Identifiers

RxCUI
1873757 1873765
UPC
0365649003301
UNII
7IK8Z952OK
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 trulance immediate release (source: ndc)
Generic Name plecanatide (source: ndc)
Application Number NDA208745 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65649-003-01) / 1 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (65649-003-03) / 3 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (65649-003-07) / 7 TABLET in 1 BOTTLE
  • 30 TABLET in 1 BOTTLE (65649-003-30)
source: ndc

Packages (4)

65649-003-01 1 BOTTLE in 1 CARTON (65649-003-01) / 1 TABLET in 1 BOTTLE 65649-003-03 1 BOTTLE in 1 CARTON (65649-003-03) / 3 TABLET in 1 BOTTLE 65649-003-07 1 BOTTLE in 1 CARTON (65649-003-07) / 7 TABLET in 1 BOTTLE 65649-003-30 30 TABLET in 1 BOTTLE (65649-003-30)

Ingredients (1)

plecanatide (3 mg/1)

Linked Drug Pages (1)

Trulance Immediate release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "154842e6-a919-ba71-e063-6394a90aebd4", "openfda": {"nui": ["N0000185500", "N0000185499"], "upc": ["0365649003301"], "unii": ["7IK8Z952OK"], "rxcui": ["1873757", "1873765"], "spl_set_id": ["fe2895bf-71a6-493a-b0ca-e06b2dfefc82"], "pharm_class_epc": ["Guanylate Cyclase-C Agonist [EPC]"], "pharm_class_moa": ["Guanylate Cyclase Activators [MoA]"], "manufacturer_name": ["Salix Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65649-003-01)  / 1 TABLET in 1 BOTTLE", "package_ndc": "65649-003-01", "marketing_start_date": "20170221"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65649-003-03)  / 3 TABLET in 1 BOTTLE", "package_ndc": "65649-003-03", "marketing_start_date": "20170221"}, {"sample": true, "description": "1 BOTTLE in 1 CARTON (65649-003-07)  / 7 TABLET in 1 BOTTLE", "package_ndc": "65649-003-07", "marketing_start_date": "20170221"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (65649-003-30)", "package_ndc": "65649-003-30", "marketing_start_date": "20170221"}], "brand_name": "Trulance Immediate release", "product_id": "65649-003_154842e6-a919-ba71-e063-6394a90aebd4", "dosage_form": "TABLET", "pharm_class": ["Guanylate Cyclase Activators [MoA]", "Guanylate Cyclase-C Agonist [EPC]"], "product_ndc": "65649-003", "generic_name": "Plecanatide", "labeler_name": "Salix Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trulance", "brand_name_suffix": "Immediate release", "active_ingredients": [{"name": "PLECANATIDE", "strength": "3 mg/1"}], "application_number": "NDA208745", "marketing_category": "NDA", "marketing_start_date": "20170221", "listing_expiration_date": "20261231"}