NDC 53002-2221 Azithromycin Dihydrate

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
53002-2221
Proprietary Name:
Azithromycin Dihydrate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rpk Pharmaceuticals, Inc.
Labeler Code:
53002
Start Marketing Date: [9]
07-18-2011
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
OVAL (C48345)
Size(s):
16 MM
Imprint(s):
APO;AZ500
Score:
1

Product Packages

NDC Code 53002-2221-2

Package Description: 2 TABLET, FILM COATED in 1 BOTTLE

NDC Code 53002-2221-5

Package Description: 5 TABLET, FILM COATED in 1 BOTTLE

NDC Code 53002-2221-6

Package Description: 6 TABLET, FILM COATED in 1 BOTTLE

Product Details

What is NDC 53002-2221?

The NDC code 53002-2221 is assigned by the FDA to the product Azithromycin Dihydrate which is product labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 53002-2221-2 2 tablet, film coated in 1 bottle , 53002-2221-5 5 tablet, film coated in 1 bottle , 53002-2221-6 6 tablet, film coated in 1 bottle . 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 Dihydrate?

Azithromycin tablets, are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2)]. 

Which are Azithromycin Dihydrate UNII Codes?

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

  • AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S)
  • AZITHROMYCIN ANHYDROUS (UNII: J2KLZ20U1M) (Active Moiety)

Which are Azithromycin Dihydrate 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 Dihydrate?

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".