0069-9500 NDC - ZITHROMAX (AZITHROMYCIN DIHYDRATE)

Drug Information

Product NDC: 0069-9500

Proprietary Name: Zithromax

Non Proprietary Name: azithromycin dihydrate

Active Ingredient(s):
  • 250 mg/1 AZITHROMYCIN DIHYDRATE


Administration Route(s): ORAL

Dosage Form(s): TABLET, FILM COATED

Pharmacy Class(es):
  • Macrolide Antimicrobial [EPC];
  • Macrolides [CS]

Labeler Information

Labeler Name: Pfizer Laboratories Div Pfizer Inc
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Start Marketing Date:4/30/2020

Package Information

No. Package Code Package Description Billing Unit
10069-9500-01500 TABLET, FILM COATED in 1 BOTTLE (0069-9500-01)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0069-9500The 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.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEZithromaxThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEazithromycin dihydrateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE4/30/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG FOR USE IN DRUG SHORTAGEProduct 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.
LABELER NAMEPfizer Laboratories Div Pfizer IncName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAZITHROMYCIN DIHYDRATEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH250 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESMacrolide Antimicrobial [EPC], Macrolides [CS] 

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This page was last updated on: 2/1/2023