Cefdinir
Cefdinir for Oral Suspension, USP Rx only
Approved
Approval ID
3ab60dc3-c39c-4580-b418-1251a1b99c73
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cefdinir
PRODUCT DETAILS
NDC Product Code53002-2654
Application NumberANDA065473
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 15, 2021
Generic NameCefdinir
INGREDIENTS (9)
CEFDINIRActive
Quantity: 125 mg in 5 mL
Code: CI0FAO63WC
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT