NDC 55648-947

CEFOTAXIME

Cefotaxime

CEFOTAXIME is a Intramuscular; Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Wockhardt Limited. The primary component is Cefotaxime Sodium.

Product ID55648-947_ae6f86a8-6a5c-4c3a-a8cb-aee20b427b5b
NDC55648-947
Product TypeHuman Prescription Drug
Proprietary NameCEFOTAXIME
Generic NameCefotaxime
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2008-06-20
Marketing CategoryANDA / ANDA
Application NumberANDA065197
Labeler NameWOCKHARDT LIMITED
Substance NameCEFOTAXIME SODIUM
Active Ingredient Strength500 mg/mL
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 55648-947-02

10 CARTON in 1 CARTON (55648-947-02) > 1 VIAL, SINGLE-DOSE in 1 CARTON (55648-947-01) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2008-06-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-947-01 [55648094701]

CEFOTAXIME INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065197
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-06-20

NDC 55648-947-02 [55648094702]

CEFOTAXIME INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065197
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-06-20
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
CEFOTAXIME SODIUM500 mg/mL

OpenFDA Data

SPL SET ID:a401a44e-2c5c-4c4a-81d8-56a3ef9d57f7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309068
  • 1656313
  • 1656318
    • UPC Code
  • 0364679948019
  • 0364679948026

    • Pharmacological Class

    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]

    NDC Crossover Matching brand name "CEFOTAXIME" or generic name "Cefotaxime"

    NDCBrand NameGeneric Name
    0143-9930CefotaximeCefotaxime
    0143-9931CefotaximeCefotaxime
    0143-9933CefotaximeCefotaxime
    0143-9935CefotaximeCefotaxime
    21586-011Cefotaximecefotaxime injection
    21586-012Cefotaximecefotaxime injection
    55648-947CEFOTAXIMECEFOTAXIME
    55648-948CEFOTAXIMECEFOTAXIME
    55648-986CEFOTAXIMECEFOTAXIME
    64679-947CefotaximeCefotaxime
    64679-948CefotaximeCefotaxime
    64679-986CefotaximeCefotaxime
    68180-811CEFOTAXIMECEFOTAXIME
    68180-822CEFOTAXIMECEFOTAXIME
    68180-833CEFOTAXIMECEFOTAXIME
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