Cefdinir
Cefdinir for Oral Suspension USP
Approved
Approval ID
2c3705f2-0b44-4d38-a7f9-4b392d0a1a45
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2012
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
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 Code68258-3053
Application NumberANDA065259
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefdinir
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2012
FDA Product Classification
INGREDIENTS (9)
CEFDINIRActive
Quantity: 250 mg in 5 mL
Code: CI0FAO63WC
Classification: ACTIB
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT