NDC 63323-402

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 ID: 63323-402_302fd27d-0a22-44ea-91fb-1b1ffcf17a1f
• NDC: 63323-402
• Product Type: Human Prescription Drug
• Proprietary Name: Aztreonam
• Generic Name: Aztreonam
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2009-11-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065439
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: AZTREONAM
• Active Ingredient Strength: 2 g/1
• Pharm Classes: Monobactam Antibacterial [EPC],Monobactams [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 63323-402-24

10 VIAL in 1 TRAY (63323-402-24) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-402-41)

• Marketing Start Date: 2009-11-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-402-30 [63323040230]

Aztreonam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA065439
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-11-05

NDC 63323-402-24 [63323040224]

Aztreonam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA065439
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-11-05

NDC 63323-402-20 [63323040220]

Aztreonam INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA065439
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-11-05

Drug Details

Active Ingredients

Ingredient	Strength
AZTREONAM	2 g/1

OpenFDA Data

• SPL SET ID: c6cf7e13-a04e-47e2-9cec-44a278ee6bec
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • G2B4VE5GH8
• RxNorm Concept Unique ID - RxCUI:
  • 1664981
  • 1664986

Pharmacological Class

• Monobactam Antibacterial [EPC]
• Monobactams [CS]

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

NDC	Brand Name	Generic Name
0409-0829	Aztreonam	Aztreonam
0409-0830	Aztreonam	Aztreonam
63323-401	Aztreonam	AZTREONAM
63323-402	Aztreonam	AZTREONAM
0003-2230	AZACTAM	AZTREONAM
0003-2240	AZACTAM	AZTREONAM
0003-2560	AZACTAM	AZTREONAM
0003-2570	AZACTAM	AZTREONAM
61958-0901	Cayston	aztreonam