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
NDC Product Code54868-3511
Application NumberANDA064156
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 8, 2010
Generic NameCefaclor
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
NDC Product Code54868-3478
Application NumberANDA064156
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 8, 2010
Generic NameCefaclor
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