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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47133-574
Application NumberNDA204417
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levetiracetam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2019
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47133-575
Application NumberNDA204417
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levetiracetam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2019
FDA Product Classification
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