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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61442-175
Application NumberANDA065412
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefaclor
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2015
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61442-176
Application NumberANDA065412
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefaclor
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2015
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61442-173
Application NumberANDA065412
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefaclor
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2015
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61442-174
Application NumberANDA065412
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefaclor
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2015
FDA Product Classification
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