Azithromycin Dihydrate
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, for oral use Initial U.S. Approval: 1991
Approved
Approval ID
9977e757-7643-45ef-b5df-ee894438b466
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 18, 2018
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
azithromycin
PRODUCT DETAILS
NDC Product Code50090-0958
Application NumberANDA065507
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 28, 2017
Generic Nameazithromycin
INGREDIENTS (9)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 MW)Inactive
Code: RFW2ET671P
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
AZITHROMYCIN DIHYDRATEActive
Quantity: 250 mg in 1 1
Code: 5FD1131I7S
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
azithromycin
PRODUCT DETAILS
NDC Product Code50090-1655
Application NumberANDA065509
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 28, 2017
Generic Nameazithromycin
INGREDIENTS (9)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 MW)Inactive
Code: RFW2ET671P
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
AZITHROMYCIN DIHYDRATEActive
Quantity: 500 mg in 1 1
Code: 5FD1131I7S
Classification: ACTIM