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
df5abe91-2866-4b1a-97f1-4c61fee8f01f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2021
Manufacturers
FDA
TAGI Pharma, Inc.
DUNS: 963322560
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Azithromycin dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51224-222
Application NumberANDA207566
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azithromycin dihydrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2021
FDA Product Classification
INGREDIENTS (9)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Azithromycin dihydrateActive
Quantity: 600 mg in 1 1
Code: 5FD1131I7S
Classification: ACTIM
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT