Cefdinir
Cefdinir for Oral Suspension USP
Approved
Approval ID
a4587ea9-c06b-4603-beea-1ef926a4d0be
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code42254-127
Application NumberANDA065259
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefdinir
Product Specifications
Route of AdministrationORAL
Effective DateMarch 30, 2011
FDA Product Classification
INGREDIENTS (9)
CEFDINIRActive
Quantity: 250 mg in 5 mL
Code: CI0FAO63WC
Classification: ACTIB
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT