azithromycin
These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 600 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
Approved
Approval ID
d470695c-c0d7-4361-8783-45f58a932ac4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 29, 2023
Manufacturers
FDA
Greenstone LLC
DUNS: 825560733
Products 2
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 Code59762-3080
Application NumberNDA050730
Product Classification
M
Marketing Category
C73605
G
Generic Name
AZITHROMYCIN
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2021
FDA Product Classification
INGREDIENTS (9)
AZITHROMYCIN DIHYDRATEActive
Quantity: 600 mg in 1 1
Code: 5FD1131I7S
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
AZITHROMYCIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59762-3051
Application NumberNDA050693
Product Classification
M
Marketing Category
C73605
G
Generic Name
AZITHROMYCIN
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2021
FDA Product Classification
INGREDIENTS (4)
AZITHROMYCIN DIHYDRATEActive
Quantity: 1 g in 1 1
Code: 5FD1131I7S
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT