Cefdinir
CEFDINIR CAPSULES, USP 300 mg Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Approved
Approval ID
18888955-4db3-4d0d-939f-eaaa5f2e0dc4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2023
Manufacturers
FDA
Ascend Laboratories, LLC
DUNS: 141250469
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 Code67877-543
Application NumberANDA210220
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cefdinir
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 23, 2021
FDA Product Classification
INGREDIENTS (11)
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
CEFDINIRActive
Quantity: 300 mg in 1 1
Code: CI0FAO63WC
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT