NDC 76519-1214

CEFDINIR

Cefdinir

CEFDINIR is a Oral Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Cefdinir Monohydrate.

Product ID76519-1214_7640dd80-1a57-9805-e053-2991aa0acbb5
NDC76519-1214
Product TypeHuman Prescription Drug
Proprietary NameCEFDINIR
Generic NameCefdinir
Dosage FormPowder, For Suspension
Route of AdministrationORAL
Marketing Start Date2018-09-17
Marketing CategoryANDA / ANDA
Application NumberANDA065332
Labeler NameH.J. Harkins Company, Inc.
Substance NameCEFDINIR MONOHYDRATE
Active Ingredient Strength250 mg/5mL
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 76519-1214-6

60 mL in 1 BOTTLE (76519-1214-6)
Marketing Start Date2018-09-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76519-1214-6 [76519121406]

CEFDINIR POWDER, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA065332
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-09-17
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CEFDINIR MONOHYDRATE250 mg/5mL

OpenFDA Data

SPL SET ID:7640dd80-1a56-9805-e053-2991aa0acbb5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 476576
  • 309054
  • Pharmacological Class

    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]

    NDC Crossover Matching brand name "CEFDINIR" or generic name "Cefdinir"

    NDCBrand NameGeneric Name
    0093-3160CefdinirCefdinir
    0093-4136CefdinirCefdinir
    0093-4137CefdinirCefdinir
    0781-2176CefdinirCefdinir
    0781-6077CefdinirCefdinir
    0781-6078CefdinirCefdinir
    10544-194CefdinirCefdinir
    16714-391CefdinirCefdinir
    16714-392CefdinirCefdinir
    16714-393CefdinirCefdinir
    17856-1150CefdinirCefdinir
    21695-620CefdinirCefdinir
    21695-622CefdinirCefdinir
    33261-905CefdinirCefdinir
    42043-250CefdinirCefdinir
    42043-251CefdinirCefdinir
    42043-252CefdinirCefdinir
    42254-127CefdinirCefdinir
    42254-177CefdinirCefdinir
    43063-466CefdinirCefdinir
    43063-597CefdinirCefdinir
    43063-852CefdinirCefdinir
    43063-853CefdinirCefdinir
    43063-959CefdinirCefdinir
    68001-150CefdinirCefdinir
    68001-362CefdinirCefdinir
    68071-1788CefdinirCefdinir
    68071-3156CefdinirCefdinir
    68071-4007CefdinirCefdinir
    68071-3032CefdinirCefdinir
    68071-3393CefdinirCefdinir
    68071-4236CefdinirCefdinir
    68071-3295CefdinirCefdinir
    68071-4419CefdinirCefdinir
    68071-4792CefdinirCefdinir
    68180-723CefdinirCefdinir
    68258-3053CefdinirCefdinir
    68180-711CefdinirCefdinir
    68180-722CefdinirCefdinir
    68788-6840CefdinirCefdinir
    68788-7062CefdinirCefdinir
    68788-7111CefdinirCefdinir
    68788-7255CefdinirCefdinir
    68788-7339CefdinirCefdinir
    68788-7375CefdinirCefdinir
    68788-9760CefdinirCefdinir
    70518-1213CefdinirCefdinir
    70934-062CefdinirCefdinir
    70934-164CefdinirCefdinir
    70934-044CefdinirCefdinir

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