0409-0144 NDC - AZITHROMYCIN ()

Drug Information

  • Product NDC: 0409-0144
  • Proprietary Name: Azithromycin
  • Non Proprietary Name:
  • Active Ingredient(s): 500 mg/1 AZITHROMYCIN MONOHYDRATE
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Macrolide Antimicrobial [EPC]; Macrolides [CS]

Labeler Information

Field Name Field Value
Labeler Name: Hospira, Inc.
Product Type:
FDA Application Number: ANDA065511
Marketing Category: ANDA
Start Marketing Date:12/30/2011
End Marketing Date:11/4/2023

Package Information

No. Package Code Package Description Billing Unit
10409-0144-1010 VIAL, SINGLE-DOSE in 1 TRAY (0409-0144-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0144-31)EA
20409-0144-1110 VIAL, SINGLE-DOSE in 1 TRAY (0409-0144-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0144-21)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0409-0144The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEAzithromycinThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE12/30/2011This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA065511This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEHospira, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC0409-0144The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEAzithromycinThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE6/26/2009This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA065500This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEHospira, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 11/21/2025

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