Cephalexin
CEPHALEXIN CAPSULES, USP
Approved
Approval ID
7b52fd9a-3cb6-4f0e-9e45-17a1eaec926d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2022
Manufacturers
FDA
Bi-Coastal Pharma International LLC
DUNS: 078397428
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 Code42582-212
Application NumberANDA062713
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2020
FDA Product Classification
INGREDIENTS (6)
CEPHALEXINActive
Quantity: 500 mg in 1 1
Code: OBN7UDS42Y
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Cephalexin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42582-211
Application NumberANDA062713
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2020
FDA Product Classification
INGREDIENTS (6)
CEPHALEXINActive
Quantity: 250 mg in 1 1
Code: OBN7UDS42Y
Classification: ACTIM
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT