FDA Product

Cefdinir

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Cefdinir

FDA Product Code

53217-298

Regulatory Information

NDC Product Code

53217-298

Application Number

ANDA065473

Marketing Category

C73584

Effective Date

May 18, 2017

Territorial Authority

USA

FDA Title

CEFDINIR FOR ORAL SUSPENSION, USPRx Only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerAidarex Pharmaceuticals LLC

DUNS Number

801503249

Active Ingredients

SUCROSE

Code: C151H8M554

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

Quantity: 125 mg in 5 mL

Code: CI0FAO63WC

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

XANTHAN GUM

Code: TTV12P4NEE

Class Code: IACT

GUAR GUM

Code: E89I1637KE

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

TRISODIUM CITRATE DIHYDRATE

Code: B22547B95K

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

CEFDINIR

Code: CI0FAO63WC

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