NDC 55648-920

Cefuroxime Axetil

Cefuroxime Axetil

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

Product ID55648-920_f4bea44f-32ac-431b-8909-e81bb02e65ac
NDC55648-920
Product TypeHuman Prescription Drug
Proprietary NameCefuroxime Axetil
Generic NameCefuroxime Axetil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2005-07-29
Marketing CategoryANDA / ANDA
Application NumberANDA065166
Labeler NameWockhardt Limited
Substance NameCEFUROXIME AXETIL
Active Ingredient Strength125 mg/1
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 55648-920-02

60 TABLET, FILM COATED in 1 BOTTLE (55648-920-02)
Marketing Start Date2005-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-920-02 [55648092002]

Cefuroxime Axetil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065166
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-07-29
Inactivation Date2020-01-31

NDC 55648-920-01 [55648092001]

Cefuroxime Axetil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065166
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2005-07-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CEFUROXIME AXETIL125 mg/1

OpenFDA Data

SPL SET ID:708b7a4d-ba1f-47b5-be4d-a01c2a7017ff
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309097
  • 309095
  • 309098
  • Pharmacological Class

    • 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

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