Cephalexin
These highlights do not include all the information needed to use CEPHALEXIN safely and effectively. See full prescribing information for CEPHALEXIN. CEPHALEXIN capsules, and CEPHALEXIN for oral suspension, for oral useInitial U.S. Approval: 1971
Approved
Approval ID
19307ff0-71de-477b-965d-ea243e5ede3a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2020
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 4
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 Code0093-4177
Application NumberANDA062703
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2020
FDA Product Classification
INGREDIENTS (9)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
CEPHALEXINActive
Quantity: 250 mg in 5 mL
Code: OBN7UDS42Y
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
Cephalexin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-4175
Application NumberANDA062703
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2020
FDA Product Classification
INGREDIENTS (9)
CEPHALEXINActive
Quantity: 125 mg in 5 mL
Code: OBN7UDS42Y
Classification: ACTIM
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
Cephalexin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-3145
Application NumberANDA062702
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2020
FDA Product Classification
INGREDIENTS (16)
CEPHALEXINActive
Quantity: 250 mg in 1 1
Code: OBN7UDS42Y
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Cephalexin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-3147
Application NumberANDA062702
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2020
FDA Product Classification
INGREDIENTS (15)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CEPHALEXINActive
Quantity: 500 mg in 1 1
Code: OBN7UDS42Y
Classification: ACTIM
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
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT