NDC 71288-008

Cefepime

Cefepime Hydrochloride

Cefepime is a Intramuscular; Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Meitheal Pharmaceuticals Inc.. The primary component is Cefepime Hydrochloride.

Product ID71288-008_56b2cd20-bf68-4317-a71e-c8ea60922b0a
NDC71288-008
Product TypeHuman Prescription Drug
Proprietary NameCefepime
Generic NameCefepime Hydrochloride
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-12-17
Marketing CategoryANDA / ANDA
Application NumberANDA091048
Labeler NameMeitheal Pharmaceuticals Inc.
Substance NameCEFEPIME HYDROCHLORIDE
Active Ingredient Strength1 g/1
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71288-008-15

10 VIAL, SINGLE-DOSE in 1 CARTON (71288-008-15) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-008-16)
Marketing Start Date2018-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71288-008-16 [71288000816]

Cefepime INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091048
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-11

NDC 71288-008-15 [71288000815]

Cefepime INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091048
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-17

Drug Details

Active Ingredients

IngredientStrength
CEFEPIME HYDROCHLORIDE1 g/1

OpenFDA Data

SPL SET ID:28f1c403-ab91-405e-bf52-ad81b1c66220
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1665093
  • 1665088

    • Pharmacological Class

    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]

    NDC Crossover Matching brand name "Cefepime" or generic name "Cefepime Hydrochloride"

    NDCBrand NameGeneric Name
    0338-1301Cefepimecefepime
    0409-9566CefepimeCefepime
    0409-9735CefepimeCefepime
    25021-121cefepimecefepime hydrochloride
    25021-122cefepimecefepime hydrochloride
    44567-130CefepimeCefepime
    44567-131CefepimeCefepime
    44567-240CefepimeCefepime
    71288-008CefepimeCefepime
    71288-009CefepimeCefepime
    44567-241CefepimeCefepime
    60505-6147CefepimeCefepime
    60505-6144CefepimeCefepime
    60505-6146CefepimeCefepime
    60505-6145CefepimeCefepime
    60505-6030CefepimeCefepime
    60505-6031CefepimeCefepime
    63323-340CefepimeCefepime
    63323-326CefepimeCefepime
    66794-210CefepimeCefepime
    66288-8100CEFEPIMECEFEPIME
    67184-1003CefepimeCefepime
    67184-1004CefepimeCefepime
    66794-209CefepimeCefepime
    67184-1002CefepimeCefepime
    71288-021CefepimeCefepime
    71288-020CefepimeCefepime
    0781-3222Cefepime HydrochlorideCefepime Hydrochloride
    0781-3223Cefepime HydrochlorideCefepime Hydrochloride
    0264-3193CEFEPIME HYDROCHLORIDE AND DEXTROSECEFEPIME HYDROCHLORIDE
    0264-3195CEFEPIME HYDROCHLORIDE AND DEXTROSECEFEPIME HYDROCHLORIDE
    0409-0217MAXIPIMECefepime
    0409-0218MAXIPIMECefepime
    0409-0219MAXIPIMECefepime
    0409-0220MAXIPIMECefepime
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