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Cefdinir

Cefdinir for Oral Suspension, USP Rx only

Approved
Approval ID

6ba585be-c2f8-a4be-e053-2991aa0a23c7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 16, 2021

Manufacturers
FDA

NuCare Pharmaceuticals,Inc.

DUNS: 010632300

Products 1

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

Cefdinir

PRODUCT DETAILS

NDC Product Code68071-4419
Application NumberANDA065473
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 16, 2021
Generic NameCefdinir

INGREDIENTS (9)

SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CEFDINIRActive
Quantity: 250 mg in 5 mL
Code: CI0FAO63WC
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
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Cefdinir - FDA Approval | MedPath