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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-1087
Application NumberANDA065058
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefaclor
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2019
FDA Product Classification
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