Zithromax

Product NDC
0069-9500
Requested package NDC
0069-9500-01
11-digit product format
000699500
Labeler code
0069
Product ID
0069-9500_6ea307ee-5dc2-4ef8-9520-5dffec6a3e55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Marketing category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start
2020-04-30
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0069-95000069-9500-01DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-9500-01EA - Each0069-9500dc471225-3b49-4b3d-9000-b4b323a8daa012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-9500ZITHROMAX (AZITHROMYCIN DIHYDRATE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]2Legacy NDC20230930_fb3d03d8-c7c1-48c4-b5ac-91ed0398f0d2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-9500-0100069950001500 TABLET, FILM COATED in 1 BOTTLE (0069-9500-01) 2020-04-300000-00-00NoNoCurrent