KEFLEX
CEPHALEXIN
Approved
Approval ID
33ad783f-b633-6a70-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 25, 2016
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CEPHALEXIN
PRODUCT DETAILS
NDC Product Code61919-358
Application NumberANDA065253
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 25, 2016
Generic NameCEPHALEXIN
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CEPHALEXINActive
Quantity: 500 mg in 1 1
Code: OBN7UDS42Y
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT