NDC 0409-0144

Azithromycin

Azithromycin

Azithromycin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Azithromycin Monohydrate.

• Product ID: 0409-0144_06fd8774-dfe7-47cb-abe3-9048e72a809d
• NDC: 0409-0144
• Product Type: Human Prescription Drug
• Proprietary Name: Azithromycin
• Generic Name: Azithromycin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2011-12-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065511
• Labeler Name: Hospira, Inc.
• Substance Name: AZITHROMYCIN MONOHYDRATE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Macrolide Antimicrobial [EPC],Macrolides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0409-0144-10

10 VIAL, SINGLE-DOSE in 1 TRAY (0409-0144-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0144-31)

• Marketing Start Date: 2011-12-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0409-0144-31 [00409014431]

Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA065511
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-02

NDC 0409-0144-10 [00409014410]

Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA065511
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-12-30

NDC 0409-0144-11 [00409014411]

Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA065500
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-06-26

NDC 0409-0144-21 [00409014421]

Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA065500
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-27

Drug Details

Active Ingredients

Ingredient	Strength
AZITHROMYCIN MONOHYDRATE	500 mg/1

OpenFDA Data

• SPL SET ID: 918925cc-8da9-4016-998c-c06ed4676ae4
• Manufacturer:
  • Hospira, Inc.
• UNII:
  • JTE4MNN1MD
• RxNorm Concept Unique ID - RxCUI:
  • 1668238

Pharmacological Class

• Macrolide Antimicrobial [EPC]
• Macrolides [CS]

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

NDC	Brand Name	Generic Name
0093-2026	Azithromycin	Azithromycin
0093-2027	Azithromycin	Azithromycin
0093-7146	Azithromycin	Azithromycin
0093-7147	Azithromycin	Azithromycin
0093-7148	Azithromycin	Azithromycin Monohydrate
0093-7149	Azithromycin	Azithromycin Monohydrate
0093-7169	Azithromycin	Azithromycin
0409-0144	Azithromycin	AZITHROMYCIN
0527-2370	azithromycin	AZITHROMYCIN MONOHYDRATE
0527-2381	azithromycin	AZITHROMYCIN MONOHYDRATE
0527-2395	azithromycin	AZITHROMYCIN MONOHYDRATE
0781-1496	Azithromycin	Azithromycin
0781-1497	Azithromycin	Azithromycin
0781-1941	Azithromycin	Azithromycin
0781-5776	Azithromycin	Azithromycin
0781-5789	Azithromycin	Azithromycin
68071-1323	Azithromycin	Azithromycin
68071-1528	Azithromycin	Azithromycin
68071-1584	Azithromycin	Azithromycin
68071-1527	Azithromycin	Azithromycin
68071-1873	Azithromycin	Azithromycin
68071-1392	Azithromycin	Azithromycin
68071-1605	Azithromycin	Azithromycin
68071-3006	Azithromycin	Azithromycin
68071-4106	Azithromycin	Azithromycin
68071-4255	Azithromycin	Azithromycin
68071-4364	Azithromycin	Azithromycin
68071-4680	Azithromycin	Azithromycin
68071-4785	Azithromycin	Azithromycin
68071-4795	AZITHROMYCIN	AZITHROMYCIN
68071-4786	Azithromycin	Azithromycin
68071-4774	Azithromycin	Azithromycin
68071-4711	Azithromycin	Azithromycin
68071-4773	AZITHROMYCIN	AZITHROMYCIN
68071-4779	Azithromycin	Azithromycin
68258-3051	azithromycin	azithromycin
68258-3012	AZITHROMYCIN	AZITHROMYCIN
68788-7082	Azithromycin	Azithromycin
68788-0713	azithromycin	azithromycin
68788-8939	Azithromycin	Azithromycin
68788-9046	Azithromycin	Azithromycin
68788-9077	Azithromycin	Azithromycin
68788-8947	Azithromycin	Azithromycin
68788-9958	Azithromycin	Azithromycin
68788-7066	Azithromycin	Azithromycin
68788-9045	Azithromycin	Azithromycin
68788-9311	Azithromycin	Azithromycin
68788-9038	azithromycin	azithromycin
68788-9078	Azithromycin	Azithromycin
68788-9959	Azithromycin	Azithromycin