Cephalexin
CEPHALEXIN CAPSULES, USP
Approved
Approval ID
27f5aa5b-28ca-4154-b37e-18a931bf3398
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2010
Manufacturers
FDA
Altura Pharmaceuticals, Inc.
DUNS: 006890545
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 Code63874-111
Application NumberANDA065215
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2010
FDA Product Classification
INGREDIENTS (8)
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CEPHALEXINActive
Quantity: 250 mg in 1 1
Code: OBN7UDS42Y
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Cephalexin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63874-112
Application NumberANDA065215
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cephalexin
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2010
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CEPHALEXINActive
Quantity: 500 mg in 1 1
Code: OBN7UDS42Y
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT