ZALEPLON
Zaleplon Capsules CIV
Approved
Approval ID
8fef39a1-b4bf-4583-b6f2-5b89990c6c86
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 23, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5908
Application NumberANDA078829
Product Classification
M
Marketing Category
C73584
G
Generic Name
ZALEPLON
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2012
FDA Product Classification
INGREDIENTS (14)
ZALEPLONActive
Quantity: 10 mg in 1 1
Code: S62U433RMH
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ZALEPLON
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5909
Application NumberANDA078829
Product Classification
M
Marketing Category
C73584
G
Generic Name
ZALEPLON
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2012
FDA Product Classification
INGREDIENTS (14)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
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
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT