MOVANTIK
These highlights do not include all the information needed to use MOVANTIK safely and effectively. See full prescribing information for MOVANTIK.MOVANTIK (naloxegol) tablets, for oral useInitial U.S. Approval: 2014
Approved
Approval ID
300a6474-ebcd-4404-8040-48fdcfcc1635
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2023
Manufacturers
FDA
RedHill Biopharma Ltd
DUNS: 533278342
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
naloxegol oxalate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57841-1300
Application NumberNDA204760
Product Classification
M
Marketing Category
C73594
G
Generic Name
naloxegol oxalate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 29, 2020
FDA Product Classification
INGREDIENTS (12)
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
NALOXEGOL OXALATEActive
Quantity: 12.5 mg in 1 1
Code: 65I14TNM33
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
naloxegol oxalate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57841-1301
Application NumberNDA204760
Product Classification
M
Marketing Category
C73594
G
Generic Name
naloxegol oxalate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 29, 2020
FDA Product Classification
INGREDIENTS (12)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NALOXEGOL OXALATEActive
Quantity: 25 mg in 1 1
Code: 65I14TNM33
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT