MedPath
FDA Product

Azithromycin

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Azithromycin

63629-8251

Regulatory Information

63629-8251

ANDA207398

C73584

December 10, 2021

USA

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

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

171714327

Active Ingredients

AZITHROMYCIN DIHYDRATE

Quantity: 500 mg in 1 1

Code: 5FD1131I7S

Class Code: ACTIM

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Code: L11K75P92J

Class Code: IACT

HYPROMELLOSE 2910 (15 MPA.S)

Code: 36SFW2JZ0W

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

Active Moieties

AZITHROMYCIN ANHYDROUS

Code: J2KLZ20U1M

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