LEVETIRACETAM
Approved
Approval ID
6d71e14f-8092-444c-afa1-2b79d69d81e6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 3
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 Code16590-685
Application NumberANDA078858
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVETIRACETAM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2011
FDA Product Classification
INGREDIENTS (11)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LEVETIRACETAMActive
Quantity: 500 mg in 1 1
Code: 44YRR34555
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
LEVETIRACETAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-867
Application NumberANDA078858
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVETIRACETAM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2011
FDA Product Classification
INGREDIENTS (12)
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LEVETIRACETAMActive
Quantity: 750 mg in 1 1
Code: 44YRR34555
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LEVETIRACETAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-320
Application NumberANDA078858
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVETIRACETAM
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2011
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LEVETIRACETAMActive
Quantity: 250 mg in 1 1
Code: 44YRR34555
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT