NDC 68289-006

Cefadroxil

Cefadroxil

Cefadroxil is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Jazeera Pharmaceutical. The primary component is Cefadroxil.

Product ID68289-006_5afe6d38-8183-4246-8cff-6287d8c1d144
NDC68289-006
Product TypeHuman Prescription Drug
Proprietary NameCefadroxil
Generic NameCefadroxil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2006-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA065260
Labeler NameJazeera Pharmaceutical
Substance NameCEFADROXIL
Active Ingredient Strength1 g/1
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68289-006-01

100 TABLET, FILM COATED in 1 BOTTLE (68289-006-01)
Marketing Start Date2006-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68289-006-01 [68289000601]

Cefadroxil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065260
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-03-31
Inactivation Date2020-01-31

NDC 68289-006-50 [68289000650]

Cefadroxil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065260
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-03-31
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CEFADROXIL1 g/1

OpenFDA Data

SPL SET ID:9a1578b7-9455-4c89-9b6f-9c0c811dc5ce
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309047
  • Pharmacological Class

    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]

    NDC Crossover Matching brand name "Cefadroxil" or generic name "Cefadroxil"

    NDCBrand NameGeneric Name
    0093-3196CefadroxilCefadroxil
    0093-4059CefadroxilCefadroxil
    0143-9766CefadroxilCefadroxil
    0143-9767CefadroxilCefadroxil
    0143-9947CefadroxilCefadroxil
    0143-9948CefadroxilCefadroxil
    10544-135CefadroxilCefadroxil
    16714-388CefadroxilCefadroxil
    16714-389CefadroxilCefadroxil
    16714-390CefadroxilCefadroxil
    21695-427CefadroxilCefadroxil
    33261-018CefadroxilCefadroxil
    42254-146CefadroxilCefadroxil
    43063-553CefadroxilCefadroxil
    43063-595CefadroxilCefadroxil
    45865-503CefadroxilCefadroxil
    49999-021CefadroxilCefadroxil
    50090-0579CefadroxilCefadroxil
    50090-0580CefadroxilCefadroxil
    68071-3147CefadroxilCefadroxil
    68071-4515CefadroxilCefadroxil
    68071-4690CefadroxilCefadroxil
    68071-4550CefadroxilCefadroxil
    68180-181CefadroxilCefadroxil
    68180-180CefadroxilCefadroxil
    68180-182CefadroxilCefadroxil
    68289-014CefadroxilCefadroxil
    68289-051CefadroxilCefadroxil
    68289-006CefadroxilCefadroxil
    68289-013CefadroxilCefadroxil
    68788-0708CefadroxilCefadroxil
    68788-6416CefadroxilCefadroxil
    70934-056CefadroxilCefadroxil
    70934-081CefadroxilCefadroxil
    52959-428CefadroxilCefadroxil
    53002-2290CefadroxilCefadroxil
    55289-589CefadroxilCefadroxil
    57237-096CefadroxilCefadroxil
    57237-098CefadroxilCefadroxil
    57297-180CefadroxilCefadroxil
    57237-097CefadroxilCefadroxil
    63304-973CEFADROXILCEFADROXIL
    63187-883CefadroxilCefadroxil
    63304-974CEFADROXILCEFADROXIL
    63629-7615CefadroxilCefadroxil
    65862-083CefadroxilCefadroxil
    65862-084CefadroxilCefadroxil
    65862-085CefadroxilCefadroxil
    66267-045CefadroxilCefadroxil
    66267-768CefadroxilCefadroxil

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.