NDC 65649-003

Trulance Immediate release

Plecanatide

Trulance Immediate release is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Salix Pharmaceuticals Inc.. The primary component is Plecanatide.

• Product ID: 65649-003_32e16caa-3e71-476b-a394-faf189345e2b
• NDC: 65649-003
• Product Type: Human Prescription Drug
• Proprietary Name: Trulance Immediate release
• Generic Name: Plecanatide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2017-02-21
• Marketing Category: NDA / NDA
• Application Number: NDA208745
• Labeler Name: Salix Pharmaceuticals Inc.
• Substance Name: PLECANATIDE
• Active Ingredient Strength: 3 mg/1
• Pharm Classes: Guanylate Cyclase-C Agonist [EPC],Guanylate Cyclase Activators [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 65649-003-01

1 BOTTLE in 1 CARTON (65649-003-01) > 1 TABLET in 1 BOTTLE

• Marketing Start Date: 2017-02-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65649-003-07 [65649000307]

Trulance Immediate release TABLET

• Marketing Category: NDA
• Application Number: NDA208745
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-02-21

NDC 65649-003-03 [65649000303]

Trulance Immediate release TABLET

• Marketing Category: NDA
• Application Number: NDA208745
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-02-21

NDC 65649-003-30 [65649000330]

Trulance Immediate release TABLET

• Marketing Category: NDA
• Application Number: NDA208745
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-02-21

NDC 65649-003-01 [65649000301]

Trulance Immediate release TABLET

• Marketing Category: NDA
• Application Number: NDA208745
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-02-21

Drug Details

OpenFDA Data

• SPL SET ID: fe2895bf-71a6-493a-b0ca-e06b2dfefc82
• Manufacturer:
  • Salix Pharmaceuticals
• UNII:
  • 7IK8Z952OK
• RxNorm Concept Unique ID - RxCUI:
  • 1873757
  • 1873765
• UPC Code:
  • 0365649003301

Pharmacological Class

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

NDC Crossover Matching brand name "Trulance Immediate release" or generic name "Plecanatide"

NDC	Brand Name	Generic Name
65649-003	Trulance	Plecanatide
70194-003	Trulance	Plecanatide