NDC 54092-546

MOTEGRITY

Prucalopride

MOTEGRITY is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Prucalopride Succinate.

• Product ID: 54092-546_36754500-401c-4066-8582-79d1261be5d8
• NDC: 54092-546
• Product Type: Human Prescription Drug
• Proprietary Name: MOTEGRITY
• Generic Name: Prucalopride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-12-14
• Marketing Category: NDA / NDA
• Application Number: NDA210166
• Labeler Name: Takeda Pharmaceuticals America, Inc.
• Substance Name: PRUCALOPRIDE SUCCINATE
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: Serotonin-4 Receptor Agonist [EPC],Serotonin 4 Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 54092-546-01

30 TABLET, FILM COATED in 1 BOTTLE (54092-546-01)

• Marketing Start Date: 2018-12-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54092-546-01 [54092054601]

MOTEGRITY TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA210166
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-12-14

Drug Details

Active Ingredients

Ingredient	Strength
PRUCALOPRIDE SUCCINATE	1 mg/1

OpenFDA Data

• SPL SET ID: bca1e4c6-4b2b-4876-8ab3-654629c4ff1b
• Manufacturer:
  • Shire US Manufacturing Inc.
• UNII:
  • 4V2G75E1CK
• RxNorm Concept Unique ID - RxCUI:
  • 2107353
  • 2107351
  • 2107345
  • 2107355

NDC Crossover Matching brand name "MOTEGRITY" or generic name "Prucalopride"

NDC	Brand Name	Generic Name
54092-546	MOTEGRITY	PRUCALOPRIDE
54092-547	MOTEGRITY	PRUCALOPRIDE