Cephalexin
Cephalexin Capsules, USP
Approved
Approval ID
12cdaf8c-06d1-45f2-b008-2ec33791bbe9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2009
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
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 Code21695-317
Application NumberANDA065253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2009
FDA Product Classification
INGREDIENTS (8)
CephalexinActive
Quantity: 500 mg in 1 1
Code: OBN7UDS42Y
Classification: ACTIM
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GelatinInactive
Code: 2G86QN327L
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Cephalexin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-316
Application NumberANDA065253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2009
FDA Product Classification
INGREDIENTS (8)
CephalexinActive
Quantity: 250 mg in 1 1
Code: OBN7UDS42Y
Classification: ACTIM
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
GelatinInactive
Code: 2G86QN327L
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT