AZITHROMYCIN
Approved
Approval ID
32ae8f5a-ea78-4e64-a58a-856ed8cf4f78
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 27, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-383
Application NumberANDA065405
Product Classification
M
Marketing Category
C73584
G
Generic Name
AZITHROMYCIN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2011
FDA Product Classification
INGREDIENTS (12)
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
AZITHROMYCIN ANHYDROUSActive
Quantity: 500 mg in 1 1
Code: J2KLZ20U1M
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
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
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT