Azithromycin Dihydrate

Basic Information

Product Name

FDA Product Code

50090-1655

Regulatory Information

NDC Product Code

50090-1655

Application Number

ANDA065509

Marketing Category

C73584

Effective Date

April 28, 2017

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

DIBASIC CALCIUM PHOSPHATE DIHYDRATE

Code: O7TSZ97GEP

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

HYDROXYPROPYL CELLULOSE (1200000 MW)

Code: RFW2ET671P

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

AZITHROMYCIN DIHYDRATE

Quantity: 500 mg in 1 1

Code: 5FD1131I7S

Class Code: ACTIM

Active Moieties

AZITHROMYCIN ANHYDROUS

Code: J2KLZ20U1M

Basic Information

Regulatory Information

Company Information

Active Ingredients

DIBASIC CALCIUM PHOSPHATE DIHYDRATE

LACTOSE MONOHYDRATE

HYDROXYPROPYL CELLULOSE (1200000 MW)

CROSCARMELLOSE SODIUM

MAGNESIUM STEARATE

HYPROMELLOSE, UNSPECIFIED

TITANIUM DIOXIDE

TRIACETIN

Active Moieties

AZITHROMYCIN ANHYDROUS