ZALEPLON
Zaleplon Capsules5 mg and 10 mgCIVRx only
Approved
Approval ID
bc7639e9-c2cb-47bb-a295-efb0f656ccd1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2009
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
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 Code21695-105
Application NumberNDA020859
Product Classification
M
Marketing Category
C73594
G
Generic Name
ZALEPLON
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2009
FDA Product Classification
INGREDIENTS (13)
ZALEPLONActive
Quantity: 10 mg in 1 1
Code: S62U433RMH
Classification: ACTIR
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
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 Code21695-376
Application NumberNDA020859
Product Classification
M
Marketing Category
C73594
G
Generic Name
ZALEPLON
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2009
FDA Product Classification
INGREDIENTS (13)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ZALEPLONActive
Quantity: 5 mg in 1 1
Code: S62U433RMH
Classification: ACTIR
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT