NDC 53002-1526

Cefdinir

Cefdinir

Cefdinir is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Cefdinir.

Product ID53002-1526_7e4ab69e-495d-4b51-bb1f-4f92b46b6d2e
NDC53002-1526
Product TypeHuman Prescription Drug
Proprietary NameCefdinir
Generic NameCefdinir
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2008-01-07
Marketing CategoryANDA / ANDA
Application NumberANDA065434
Labeler NameRPK Pharmaceuticals, Inc.
Substance NameCEFDINIR
Active Ingredient Strength300 mg/1
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 53002-1526-1

10 CAPSULE in 1 BOTTLE (53002-1526-1)
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-1526-1 [53002152601]

Cefdinir CAPSULE
Marketing CategoryANDA
Application NumberANDA065434
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

NDC 53002-1526-2 [53002152602]

Cefdinir CAPSULE
Marketing CategoryANDA
Application NumberANDA065434
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CEFDINIR300 mg/1

OpenFDA Data

SPL SET ID:064e3f74-9644-49bd-abef-20e1dd97794e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200346
  • 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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