ZALEPLON
ZALEPLON - zaleplone capsuleCIVRx Only
Approved
Approval ID
4ccb8d3d-31ef-49ff-8567-c620b9d74f8c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ZALEPLON
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-957
Application NumberANDA078989
Product Classification
M
Marketing Category
C73584
G
Generic Name
ZALEPLON
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2011
FDA Product Classification
INGREDIENTS (12)
ZALEPLONActive
Quantity: 10 mg in 1 1
Code: S62U433RMH
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDE, COLLOIDALInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERRIC OXIDE BLACKInactive
Code: XM0M87F357
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT