CEFACLOR
CEFACLOR CAPSULES USP AND CEFACLOR FOR ORAL SUSPENSION USPRx only
Approved
Approval ID
9e8890f0-e04a-4555-ac8d-d1b792a5c276
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 20, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-782
Application NumberANDA064164
Product Classification
M
Marketing Category
C73584
G
Generic Name
CEFACLOR
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2008
FDA Product Classification
INGREDIENTS (10)
CefaclorActive
Quantity: 250 mg in 5 mL
Code: 69K7K19H4L
Classification: ACTIB
citric acidInactive
Code: 2968PHW8QP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
sodium citrateInactive
Code: 1Q73Q2JULR
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT