azithromycin monohydrate
These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, 500 mg, for oral use Initial U.S. Approval: 1991
Approved
Approval ID
f07ac620-b9a3-4aa4-92cc-dde90e52670d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2018
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
azithromycin monohydrate
PRODUCT DETAILS
NDC Product Code53217-403
Application NumberANDA065399
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 24, 2018
Generic Nameazithromycin monohydrate
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
AZITHROMYCIN MONOHYDRATEActive
Quantity: 500 mg in 1 1
Code: JTE4MNN1MD
Classification: ACTIM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT