ZALEPLON
Zaleplon Capsules USP CIV Rx only
Approved
Approval ID
cff46def-c452-49bb-abea-480de8f432bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 2019
Manufacturers
FDA
Rising Health, LLC
DUNS: 080500961
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 Code57237-240
Application NumberANDA078829
Product Classification
M
Marketing Category
C73584
G
Generic Name
ZALEPLON
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2019
FDA Product Classification
INGREDIENTS (14)
ZALEPLONActive
Quantity: 10 mg in 1 1
Code: S62U433RMH
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
ZALEPLON
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57237-239
Application NumberANDA078829
Product Classification
M
Marketing Category
C73584
G
Generic Name
ZALEPLON
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2019
FDA Product Classification
INGREDIENTS (14)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
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 YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ZALEPLONActive
Quantity: 5 mg in 1 1
Code: S62U433RMH
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT