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  4. NDC Product Code: 57297-160 Azithromycin Monohydrate

NDC 57297-160 Azithromycin Monohydrate

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 57297-160?
  5. Azithromycin Monohydrate Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
57297-160
Proprietary Name:
Azithromycin Monohydrate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Lupin Limited
Labeler Code:
57297
Product Label ID:
782fc23e-1df2-4a84-98a2-36eb81268f92
Start Marketing Date: [9]
07-22-2015
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328)
Shape:
OVAL (C48345)
Size(s):
14 MM
Imprint(s):
LU;L11
Score:
1

Product Packages

NDC Code 57297-160-06

Package Description: 30 TABLET in 1 CONTAINER

NDC Code 57297-160-13

Package Description: 3 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK

Product Details

What is NDC 57297-160?

The NDC code 57297-160 is assigned by the FDA to the product Azithromycin Monohydrate which is product labeled by Lupin Limited. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 57297-160-06 30 tablet in 1 container , 57297-160-13 3 blister pack in 1 carton / 6 tablet in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Azithromycin Monohydrate?

  Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae .   Acute bacterial sinusitis due to Haemophilus influenzae , Moraxella catarrhalis or Streptococcus pneumoniae .   Community-acquired pneumonia due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy.   Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.   Uncomplicated skin and skin structure infections due to Staphylococcus aureus , Streptococcus pyogenes , or Streptococcus agalactiae .   Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae .   Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.

Which are Azithromycin Monohydrate UNII Codes?

The UNII codes for the active ingredients in this product are:

  • AZITHROMYCIN MONOHYDRATE (UNII: JTE4MNN1MD)
  • AZITHROMYCIN ANHYDROUS (UNII: J2KLZ20U1M) (Active Moiety)

Which are Azithromycin Monohydrate Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Azithromycin Monohydrate?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".