Cefaclor
Approved
Approval ID
fe8b7729-d870-4e61-a5a4-91e28bdd5a94
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefaclor
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3511
Application NumberANDA064156
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefaclor
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2010
FDA Product Classification
INGREDIENTS (11)
CEFACLORActive
Quantity: 500 mg in 1 1
Code: 69K7K19H4L
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Cefaclor
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3478
Application NumberANDA064156
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefaclor
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2010
FDA Product Classification
INGREDIENTS (11)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CEFACLORActive
Quantity: 250 mg in 1 1
Code: 69K7K19H4L
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT