Cefaclor
CEFACLOR EXTENDED-RELEASE TABLETS USPRx only
Approved
Approval ID
0878bdc2-0410-4938-9890-96523aa81c2f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2019
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefaclor
PRODUCT DETAILS
NDC Product Code0093-1087
Application NumberANDA065058
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 31, 2019
Generic NameCefaclor
INGREDIENTS (11)
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
CEFACLORActive
Quantity: 500 mg in 1 1
Code: 69K7K19H4L
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7L
Classification: IACT