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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53002-2654
Application NumberANDA065473
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefdinir
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2021
FDA Product Classification
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