Cephalexin
CEPHALEXIN CAPSULES USP, 250 mg and 500 mg / CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL / CEPHALEXIN TABLETS USP, 250 mg and 500 mg314531474175417722382240Rx only
Approved
Approval ID
12b6bac5-00a3-437b-a172-d4e09c273c8c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 6, 2010
Manufacturers
FDA
Blenheim Pharmacal, Inc.
DUNS: 171434587
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cephalexin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10544-020
Application NumberANDA062702
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2010
FDA Product Classification
INGREDIENTS (15)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CEPHALEXINActive
Quantity: 500 mg in 1 1
Code: OBN7UDS42Y
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT