Elepsia XR
These highlights do not include all the information needed to use ELEPSIA XR safely and effectively. See full prescribing information for ELEPSIA XR. ELEPSIA™ XR (levetiracetam) extended-release tablets, for oral use Initial U.S. Approval: 1999
Approved
Approval ID
12e147dc-4f5b-4117-8a8e-a8c429ad0217
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 6, 2021
Manufacturers
FDA
Sun Pharma Advanced Research Company Limited
DUNS: 676162401
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levetiracetam
PRODUCT DETAILS
NDC Product Code47133-574
Application NumberNDA204417
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 28, 2019
Generic NameLevetiracetam
INGREDIENTS (23)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LEVETIRACETAMActive
Quantity: 1000 mg in 1 1
Code: 44YRR34555
Classification: ACTIB
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
Levetiracetam
PRODUCT DETAILS
NDC Product Code47133-575
Application NumberNDA204417
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 28, 2019
Generic NameLevetiracetam
INGREDIENTS (23)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
LEVETIRACETAMActive
Quantity: 1500 mg in 1 1
Code: 44YRR34555
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT