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 use Initial U.S. Approval: 1991
Approved
Approval ID
ccf371e5-268c-4a89-a39b-4ca25e5035fc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2021
Manufacturers
FDA
Wockhardt USA LLC.
DUNS: 170508365
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 Code64679-961
Application NumberANDA065404
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azithromycin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2021
FDA Product Classification
INGREDIENTS (12)
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
MAGNESIUM TRISILICATEInactive
Code: C2E1CI501T
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
AZITHROMYCIN ANHYDROUSActive
Quantity: 250 mg in 1 1
Code: J2KLZ20U1M
Classification: ACTIB
Azithromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64679-964
Application NumberANDA065405
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azithromycin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2021
FDA Product Classification
INGREDIENTS (12)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MAGNESIUM TRISILICATEInactive
Code: C2E1CI501T
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
AZITHROMYCIN ANHYDROUSActive
Quantity: 500 mg in 1 1
Code: J2KLZ20U1M
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT