Azithromycin
These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS, USP.Azithromycin Tablets, USP 250 mg and 500 mgInitial U.S. Approval: 1991
Approved
Approval ID
4ece67c7-b351-48bf-8488-823827952272
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2015
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53217-173
Application NumberANDA065211
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azithromycin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2015
FDA Product Classification
INGREDIENTS (12)
AZITHROMYCIN MONOHYDRATEActive
Quantity: 250 mg in 1 1
Code: JTE4MNN1MD
Classification: ACTIM
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT