Cefaclor
Cefaclor for Oral Suspension, USP
Approved
Approval ID
9f919252-7a87-4386-a64c-5d8213f7e881
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 9, 2015
Manufacturers
FDA
Carlsbad Technology, Inc.
DUNS: 781047246
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefaclor
PRODUCT DETAILS
NDC Product Code61442-175
Application NumberANDA065412
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 9, 2015
Generic NameCefaclor
INGREDIENTS (6)
CefaclorActive
Quantity: 250 mg in 5 mL
Code: 69K7K19H4L
Classification: ACTIM
METHYLCELLULOSE (25 CPS)Inactive
Code: BI55GG2WLI
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Cefaclor
PRODUCT DETAILS
NDC Product Code61442-176
Application NumberANDA065412
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 9, 2015
Generic NameCefaclor
INGREDIENTS (6)
CefaclorActive
Quantity: 375 mg in 5 mL
Code: 69K7K19H4L
Classification: ACTIM
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
METHYLCELLULOSE (25 CPS)Inactive
Code: BI55GG2WLI
Classification: IACT
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Cefaclor
PRODUCT DETAILS
NDC Product Code61442-173
Application NumberANDA065412
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 9, 2015
Generic NameCefaclor
INGREDIENTS (6)
CefaclorActive
Quantity: 125 mg in 5 mL
Code: 69K7K19H4L
Classification: ACTIM
METHYLCELLULOSE (25 CPS)Inactive
Code: BI55GG2WLI
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Cefaclor
PRODUCT DETAILS
NDC Product Code61442-174
Application NumberANDA065412
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 9, 2015
Generic NameCefaclor
INGREDIENTS (6)
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
CefaclorActive
Quantity: 187 mg in 5 mL
Code: 69K7K19H4L
Classification: ACTIM
METHYLCELLULOSE (25 CPS)Inactive
Code: BI55GG2WLI
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT