Cefdinir
CEFDINIR FOR ORAL SUSPENSION USP Rx only
Approved
Approval ID
be474782-045b-478f-a701-37976fb1b694
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2018
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
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 Code53217-406
Application NumberANDA065332
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefdinir
Product Specifications
Route of AdministrationORAL
Effective DateAugust 24, 2018
FDA Product Classification
INGREDIENTS (9)
CEFDINIR MONOHYDRATEActive
Quantity: 250 mg in 5 mL
Code: 6E7SN358SE
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Code: RS7A450LGA
Classification: IACT