ZITHROMAX

Product NDC
0069-3051
11-digit product format
000693051
Labeler code
0069
Product ID
0069-3051_04ff75a3-1031-4a4e-849a-30cf77a53a7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN DIHYDRATE
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA050693
Marketing category
NDA
Marketing start
1994-09-28
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
1 g/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-3051-07EA - Each0069-30519c0c7ac9-3a52-40cb-8ac6-4ba88ce6294712012-07-24
0069-3051-75EA - Each0069-3051b80cf388-20aa-40eb-960e-e28888b98d8c12012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-3051ZITHROMAX (AZITHROMYCIN DIHYDRATE) TABLET, FILM COATED ZITHROMAX (AZITHROMYCIN DIHYDRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]41Legacy NDC20250406_b749df83-49b0-433e-8a62-589a048dd716.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-3051-070006930510710 PACKET in 1 BOX (0069-3051-07) > 1 POWDER, FOR SUSPENSION in 1 PACKET (0069-3051-01) 10 packet1994-09-280000-00-00NoNoCurrent
0069-3051-75000693051753 PACKET in 1 BOX (0069-3051-75) > 1 POWDER, FOR SUSPENSION in 1 PACKET (0069-3051-01) 3 packet1994-09-280000-00-00NoNoCurrent