AZITHROMYCIN MONOHYDRATE
AZITHROMYCIN
Approved
Approval ID
4a3a000d-baee-74a3-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2020
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
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 Code61919-096
Application NumberANDA065399
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 17, 2020
Generic NameAZITHROMYCIN MONOHYDRATE
INGREDIENTS (10)
AZITHROMYCIN MONOHYDRATEActive
Quantity: 500 mg in 1 1
Code: JTE4MNN1MD
Classification: ACTIM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT