Azithromycin
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 useInitial U.S. Approval: 1991
Approved
Approval ID
bf0ed82e-6a7f-436c-9ee7-fd47b1c9fc3e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 23, 2017
Manufacturers
FDA
Vivimed Labs Limited
DUNS: 650210664
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 Code62980-962
Application NumberANDA065302
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azithromycin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2017
FDA Product Classification
INGREDIENTS (12)
AZITHROMYCIN ANHYDROUSActive
Quantity: 600 mg in 1 1
Code: J2KLZ20U1M
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MAGNESIUM TRISILICATEInactive
Code: C2E1CI501T
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT