ZALEPLON
ZALEPLON - zaleplone capsuleCIVRx Only
Approved
Approval ID
2f44db39-e1d9-451e-ba31-e4b10366a430
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2010
Manufacturers
FDA
Ascend Laboratories, LLC
DUNS: 141250469
Products 2
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 Code67877-210
Application NumberANDA078989
Product Classification
M
Marketing Category
C73584
G
Generic Name
ZALEPLON
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2010
FDA Product Classification
INGREDIENTS (13)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERRIC OXIDE BLACKInactive
Code: XM0M87F357
Classification: IACT
ZALEPLONActive
Quantity: 5 mg in 1 1
Code: S62U433RMH
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDE, COLLOIDALInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
ZALEPLON
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-211
Application NumberANDA078989
Product Classification
M
Marketing Category
C73584
G
Generic Name
ZALEPLON
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2010
FDA Product Classification
INGREDIENTS (12)
ZALEPLONActive
Quantity: 10 mg in 1 1
Code: S62U433RMH
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDE, COLLOIDALInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERRIC OXIDE BLACKInactive
Code: XM0M87F357
Classification: IACT