FDA.reportPublic FDA data

Zmax

Product NDC
21695-444
11-digit product format
216950444
Labeler code
21695
Product ID
21695-444_c61229e8-75cb-4776-9883-c5630bc38a32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA050797
Marketing category
NDA
Marketing start
1995-06-10
Marketing end
0000-00-00
Substance
AZITHROMYCIN
Active strength
2 g/60mL
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-444-602019-09-24C16284748780-1934fe258-498f-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use ZMAX safely and effectively. See full prescribing information for ZMAX. ZMAX (azithromycin) powder, for suspension for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-444-60Zmax60 mL in 1 BOTTLEPOWDER, FOR SUSPENSION601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
azithromycinACTIVE INGREDIENTF94OW58Y8VZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
azithromycinACTIVE MOIETYF94OW58Y8VZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
glyceryl behenateINACTIVE INGREDIENTR8WTH25YS2ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
magnesium hydroxideINACTIVE INGREDIENTNBZ3QY004SZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
sodium phosphate, tribasic anhydrousINACTIVE INGREDIENTSX01TZO3QZZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
sucroseINACTIVE INGREDIENTC151H8M554ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEEZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-444ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110127_c61229e8-75cb-4776-9883-c5630bc38a32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577378azithromycin 2 GM in 60 mL Extended Release Oral SuspensionPSNc61229e8-75cb-4776-9883-c5630bc38a321
583482Zmax 2 GM in 60 mL Extended Release Oral SuspensionPSNc61229e8-75cb-4776-9883-c5630bc38a321
583482azithromycin 33.3 MG/ML Extended Release Suspension [Zmax]SBDc61229e8-75cb-4776-9883-c5630bc38a321
577378azithromycin 33.3 MG/ML Extended Release SuspensionSCDc61229e8-75cb-4776-9883-c5630bc38a321
577378azithromycin 2 GM per 60 ML Extended Release SuspensionSYc61229e8-75cb-4776-9883-c5630bc38a321
583482Zmax 2 GM per 60 ML Extended Release SuspensionSYc61229e8-75cb-4776-9883-c5630bc38a321
583482Zmax 33.3 MG/ML Extended Release SuspensionSYc61229e8-75cb-4776-9883-c5630bc38a321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-444-602169504446060 mL in 1 BOTTLE60 mlHistorical