NDC 70194-003

Trulance Immediate release

Plecanatide

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

• Product ID: 70194-003_4fca090f-64af-4fcc-9595-4e70b443d917
• NDC: 70194-003
• 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: Synergy 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: 2019-12-31

Packaging

NDC 70194-003-30

1 BLISTER PACK in 1 CARTON (70194-003-30) > 30 TABLET in 1 BLISTER PACK

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

NDC SPL Data Element Entries

NDC 70194-003-30 [70194000330]

Trulance Immediate release TABLET

• Marketing Category: NDA
• Application Number: NDA208745
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-02-21
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-04-13

Drug Details

Active Ingredients

Ingredient	Strength
PLECANATIDE	3 mg/1

OpenFDA Data

• SPL SET ID: f1766455-79a2-409f-9325-0e3d6743acc7
• Manufacturer:
  • Synergy Pharmaceuticals Inc.
• UNII:
  • 7IK8Z952OK
• RxNorm Concept Unique ID - RxCUI:
  • 1873757
  • 1873765

Pharmacological Class

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

Medicade Reported Pricing

70194000330 TRULANCE 3 MG TABLET

Pricing Unit: EA | Drug Type:

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