NDC 68071-1637

Cefuroxime axetil

Cefuroxime Axetil

Cefuroxime axetil is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Cefuroxime Axetil.

Product ID68071-1637_834775f0-58cd-215c-e053-2991aa0a5ddd
NDC68071-1637
Product TypeHuman Prescription Drug
Proprietary NameCefuroxime axetil
Generic NameCefuroxime Axetil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA065496
Labeler NameNuCare Pharmaceuticals,Inc.
Substance NameCEFUROXIME AXETIL
Active Ingredient Strength500 mg/1
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68071-1637-2

20 TABLET, FILM COATED in 1 BOTTLE (68071-1637-2)
Marketing Start Date2019-03-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-1637-2 [68071163702]

Cefuroxime axetil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065496
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-04

Drug Details

Active Ingredients

IngredientStrength
CEFUROXIME AXETIL500 mg/1

OpenFDA Data

SPL SET ID:83476d51-be74-748b-e053-2a91aa0a3d36
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309098
  • UPC Code
  • 0368071163728
  • Pharmacological Class

    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]
    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]

    NDC Crossover Matching brand name "Cefuroxime axetil" or generic name "Cefuroxime Axetil"

    NDCBrand NameGeneric Name
    16714-400Cefuroxime AxetilCefuroxime Axetil
    16714-401Cefuroxime AxetilCefuroxime Axetil
    21695-150Cefuroxime axetilCefuroxime axetil
    21695-370Cefuroxime axetilCefuroxime axetil
    43063-584cefuroxime axetilcefuroxime axetil
    43063-623Cefuroxime AxetilCefuroxime Axetil
    43063-656Cefuroxime axetilCefuroxime axetil
    43063-657Cefuroxime axetilCefuroxime axetil
    49999-785cefuroxime axetilcefuroxime axetil
    50090-0781Cefuroxime AxetilCefuroxime Axetil
    50090-0798cefuroxime axetilcefuroxime axetil
    50090-2157Cefuroxime axetilCefuroxime axetil
    50090-2158Cefuroxime axetilCefuroxime axetil
    50090-2159Cefuroxime axetilCefuroxime axetil
    50090-4153Cefuroxime AxetilCefuroxime Axetil
    51407-333Cefuroxime axetilCefuroxime axetil
    67877-215Cefuroxime axetilCefuroxime axetil
    67877-216Cefuroxime axetilCefuroxime axetil
    68071-1637Cefuroxime axetilCefuroxime axetil
    68071-3000Cefuroxime AxetilCefuroxime Axetil
    68071-3291Cefuroxime AxetilCefuroxime Axetil
    68180-302cefuroxime axetilcefuroxime axetil
    68180-303cefuroxime axetilcefuroxime axetil
    68788-9333Cefuroxime AxetilCefuroxime Axetil
    68788-9700cefuroxime axetilcefuroxime axetil
    68788-9914Cefuroxime AxetilCefuroxime Axetil
    68788-9701cefuroxime axetilcefuroxime axetil
    70934-088Cefuroxime AxetilCefuroxime Axetil
    52343-062Cefuroxime AxetilCefuroxime Axetil
    52343-063Cefuroxime AxetilCefuroxime Axetil
    52959-308Cefuroxime axetilCefuroxime axetil
    52959-939Cefuroxime AxetilCefuroxime Axetil
    55648-921Cefuroxime AxetilCefuroxime Axetil
    55289-385Cefuroxime AxetilCefuroxime Axetil
    55648-922Cefuroxime AxetilCefuroxime Axetil
    55700-436Cefuroxime AxetilCefuroxime Axetil
    55648-920Cefuroxime AxetilCefuroxime Axetil
    55700-655Cefuroxime axetilCefuroxime axetil
    57237-058Cefuroxime AxetilCefuroxime Axetil
    57297-302cefuroxime axetilcefuroxime axetil
    57237-059Cefuroxime AxetilCefuroxime Axetil
    57297-303cefuroxime axetilcefuroxime axetil
    60429-657cefuroxime axetilcefuroxime axetil
    60429-656cefuroxime axetilcefuroxime axetil
    60687-272Cefuroxime axetilCefuroxime axetil
    61919-044CEFUROXIME AXETILCEFUROXIME AXETIL
    61919-145CEFUROXIME AXETILCEFUROXIME AXETIL
    63187-991Cefuroxime axetilCefuroxime axetil
    64679-920Cefuroxime AxetilCefuroxime Axetil
    64679-921Cefuroxime AxetilCefuroxime Axetil

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