Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Ascend Laboratories, LLC
141250469
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Unichem Laboratories Limited
H.J. Harkins Company, Inc.
Ascend Laboratories, LLC
915389741
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ZALEPLON
Product Details
NDC Product Code
52959-957Application Number
ANDA078989Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 31, 2011ZaleplonActive
Code: S62U433RMHClass: ACTIBQuantity: 10 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SILICON DIOXIDE, COLLOIDALInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSEInactive
Code: J2B2A4N98GClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FERRIC OXIDE BLACKInactive
Code: XM0M87F357Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT