MedPath

Cefdinir

Cefdinir for Oral Suspension USP

Approved
Approval ID

37b5d000-db9e-4b6e-8208-6361e98fb55d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 1, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

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

Cefdinir

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-6171
Application NumberANDA065259
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefdinir
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2020
FDA Product Classification

INGREDIENTS (9)

ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
CEFDINIRActive
Quantity: 250 mg in 5 mL
Code: CI0FAO63WC
Classification: ACTIB
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT

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