NDC 63323-401

Aztreonam

Aztreonam

Aztreonam is a Intramuscular; Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Aztreonam.

Product ID63323-401_302fd27d-0a22-44ea-91fb-1b1ffcf17a1f
NDC63323-401
Product TypeHuman Prescription Drug
Proprietary NameAztreonam
Generic NameAztreonam
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2009-11-05
Marketing CategoryANDA / ANDA
Application NumberANDA065439
Labeler NameFresenius Kabi USA, LLC
Substance NameAZTREONAM
Active Ingredient Strength1 g/1
Pharm ClassesMonobactam Antibacterial [EPC],Monobactams [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-401-24

10 VIAL in 1 TRAY (63323-401-24) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-401-41)
Marketing Start Date2009-11-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-401-20 [63323040120]

Aztreonam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065439
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-05

NDC 63323-401-24 [63323040124]

Aztreonam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065439
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-05

NDC 63323-401-26 [63323040126]

Aztreonam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065439
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-05

Drug Details

Active Ingredients

IngredientStrength
AZTREONAM1 g/1

OpenFDA Data

SPL SET ID:5f5ebb63-6ac5-4fb4-bcc1-d069c123eb18
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1664981
  • 1664986
  • Pharmacological Class

    • Monobactam Antibacterial [EPC]
    • Monobactams [CS]

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

    NDCBrand NameGeneric Name
    0409-0829AztreonamAztreonam
    0409-0830AztreonamAztreonam
    63323-401AztreonamAZTREONAM
    63323-402AztreonamAZTREONAM
    0003-2230AZACTAMAZTREONAM
    0003-2240AZACTAMAZTREONAM
    0003-2560AZACTAMAZTREONAM
    0003-2570AZACTAMAZTREONAM
    61958-0901Caystonaztreonam

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