Cefdinir
Cefdinir for Oral Suspension, USP Rx only
Approved
Approval ID
96cad498-70d3-3089-e053-2995a90a9d19
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-5106
Application NumberANDA065473
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefdinir
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2021
FDA Product Classification
INGREDIENTS (9)
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
CEFDINIRActive
Quantity: 250 mg in 5 mL
Code: CI0FAO63WC
Classification: ACTIB