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
7e228ad6-2c24-4994-a0d0-040f59eaa4d2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2018
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
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 Code53002-2221
Application NumberANDA065509
Product Classification
M
Marketing Category
C73584
G
Generic Name
azithromycin
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2017
FDA Product Classification
INGREDIENTS (9)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYDROXYPROPYL CELLULOSE (1200000 MW)Inactive
Code: RFW2ET671P
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AZITHROMYCIN DIHYDRATEActive
Quantity: 500 mg in 1 1
Code: 5FD1131I7S
Classification: ACTIM
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT