cephalexin
Cephalexin Capsules, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsule, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Approved
Approval ID
ec678657-42f1-4a51-a596-129033e2ff60
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 14, 2010
Manufacturers
FDA
Sun Pharmaceutical Industries Limited
DUNS: 650172430
Products 2
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 Code62756-293
Application NumberANDA062791
Product Classification
M
Marketing Category
C73584
G
Generic Name
cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2010
FDA Product Classification
INGREDIENTS (8)
CEPHALEXINActive
Quantity: 250 mg in 1 1
Code: OBN7UDS42Y
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
cephalexin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-294
Application NumberANDA062791
Product Classification
M
Marketing Category
C73584
G
Generic Name
cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2010
FDA Product Classification
INGREDIENTS (9)
CEPHALEXINActive
Quantity: 500 mg in 1 1
Code: OBN7UDS42Y
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT