Levetiracetam
Levetiracetam
Approved
Approval ID
eb02779c-acdc-48ed-9d23-ca39ba152d0d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2012
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 Code42254-056
Application NumberANDA078526
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levetiracetam
Product Specifications
Route of AdministrationORAL
Effective DateJune 27, 2011
FDA Product Classification
INGREDIENTS (13)
LEVETIRACETAMActive
Quantity: 500 mg in 1 1
Code: 44YRR34555
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT