Zmax
These 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
Approved
Approval ID
c61229e8-75cb-4776-9883-c5630bc38a32
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
azithromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-444
Application NumberNDA050797
Product Classification
M
Marketing Category
C73594
G
Generic Name
azithromycin
Product Specifications
Route of AdministrationORAL
Effective DateApril 20, 2010
FDA Product Classification
INGREDIENTS (10)
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
magnesium hydroxideInactive
Code: NBZ3QY004S
Classification: IACT
azithromycinActive
Quantity: 2 g in 60 mL
Code: F94OW58Y8V
Classification: ACTIB
sucroseInactive
Code: C151H8M554
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
glyceryl behenateInactive
Code: R8WTH25YS2
Classification: IACT
poloxamer 407Inactive
Code: TUF2IVW3M2
Classification: IACT
sodium phosphate, tribasic anhydrousInactive
Code: SX01TZO3QZ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT