MOTEGRITY
These highlights do not include all the information needed to use MOTEGRITY safely and effectively. See full prescribing information for MOTEGRITY. MOTEGRITY (prucalopride) tablets, for oral use Initial U.S. Approval: 2018
Approved
Approval ID
bca1e4c6-4b2b-4876-8ab3-654629c4ff1b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 28, 2022
Manufacturers
FDA
Takeda Pharmaceuticals America, Inc.
DUNS: 039997266
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PRUCALOPRIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-546
Application NumberNDA210166
Product Classification
M
Marketing Category
C73594
G
Generic Name
PRUCALOPRIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2020
FDA Product Classification
INGREDIENTS (9)
PRUCALOPRIDE SUCCINATEActive
Quantity: 1 mg in 1 1
Code: 4V2G75E1CK
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3000Inactive
Code: SA1B764746
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
PRUCALOPRIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-547
Application NumberNDA210166
Product Classification
M
Marketing Category
C73594
G
Generic Name
PRUCALOPRIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2020
FDA Product Classification
INGREDIENTS (12)
PRUCALOPRIDE SUCCINATEActive
Quantity: 2 mg in 1 1
Code: 4V2G75E1CK
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3000Inactive
Code: SA1B764746
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT