Keppra
KEPPRA (levetiracetam) 250 mg, 500 mg, 750 mg, and 1000 mg tablets 100 mg/mL oral solution
Approved
Approval ID
d1329893-a8bc-4f31-a31b-76690d111035
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
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 Code21695-070
Application NumberNDA021035
Product Classification
M
Marketing Category
C73594
G
Generic Name
levetiracetam
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2010
FDA Product Classification
INGREDIENTS (12)
levetiracetamActive
Quantity: 500 mg in 1 1
Code: 44YRR34555
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
polyethylene glycol 6000Inactive
Code: 30IQX730WE
Classification: IACT
polyvinyl alcoholInactive
Code: 532B59J990
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
FD&C yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
aluminum oxideInactive
Code: LMI26O6933
Classification: IACT