azithromycin

Basic Information

Product Name

azithromycin

FDA Product Code

59762-3080

Regulatory Information

NDC Product Code

59762-3080

Application Number

NDA050730

Marketing Category

C73605

Effective Date

November 15, 2021

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 600 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

AZITHROMYCIN DIHYDRATE

Quantity: 600 mg in 1 1

Code: 5FD1131I7S

Class Code: ACTIM

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Code: L11K75P92J

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

LACTOSE, UNSPECIFIED FORM

Code: J2B2A4N98G

Class Code: IACT

Active Moieties

AZITHROMYCIN ANHYDROUS

Code: J2KLZ20U1M

Basic Information

Regulatory Information

Company Information

Active Ingredients

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

MAGNESIUM STEARATE

CROSCARMELLOSE SODIUM

SODIUM LAURYL SULFATE

HYPROMELLOSE, UNSPECIFIED

TRIACETIN

TITANIUM DIOXIDE

LACTOSE, UNSPECIFIED FORM

Active Moieties

AZITHROMYCIN ANHYDROUS