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Cefixime

These highlights do not include all the information needed to use CEFIXIME FOR ORAL SUSPENSION safely and effectively. See full prescribing information for for Oral Suspension USP, 100 mg/5 mL for Oral Suspension USP, 200 mg/5 mL For oral administration Initial U.S. Approval:1986 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefixime for oral suspension, USP and other antibacterial drugs, Cefixime for oral suspension, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

Approved
Approval ID

54db9828-803c-4e82-8202-cee919330786

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 9, 2023

Manufacturers
FDA

Belcher Pharmaceuticals,LLC

DUNS: 965082543

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

cefixime

PRODUCT DETAILS

NDC Product Code62250-663
Application NumberANDA206938
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 9, 2023
Generic Namecefixime

INGREDIENTS (6)

SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
CEFIXIMEActive
Quantity: 100 mg in 5 mL
Code: 97I1C92E55
Classification: ACTIM

cefixime

PRODUCT DETAILS

NDC Product Code62250-664
Application NumberANDA206938
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 9, 2023
Generic Namecefixime

INGREDIENTS (6)

STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CEFIXIMEActive
Quantity: 200 mg in 5 mL
Code: 97I1C92E55
Classification: ACTIM
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