This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
FDA Drug information

Azithromycin

Read time: 1 mins
Marketing start date: 21 Dec 2024
...
 

Summary of product characteristics


Effective Time

20221101

Version

4

Spl Product Data Elements

Azithromycin Azithromycin AZITHROMYCIN DIHYDRATE AZITHROMYCIN ANHYDROUS FD&C RED NO. 40 HYDROXYPROPYL CELLULOSE (90000 WAMW) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS SUCROSE XANTHAN GUM WHITE TO LIGHT PINK CHERRY RIPE BANANA Azithromycin Azithromycin AZITHROMYCIN DIHYDRATE AZITHROMYCIN ANHYDROUS FD&C RED NO. 40 HYDROXYPROPYL CELLULOSE (90000 WAMW) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS SUCROSE XANTHAN GUM WHITE TO LIGHT PINK CHERRY RIPE BANANA Azithromycin Azithromycin AZITHROMYCIN DIHYDRATE AZITHROMYCIN ANHYDROUS FD&C RED NO. 40 HYDROXYPROPYL CELLULOSE (90000 WAMW) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS SUCROSE XANTHAN GUM WHITE TO LIGHT PINK CHERRY RIPE BANANA Azithromycin Azithromycin AZITHROMYCIN DIHYDRATE AZITHROMYCIN ANHYDROUS FD&C RED NO. 40 HYDROXYPROPYL CELLULOSE (90000 WAMW) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS SUCROSE XANTHAN GUM WHITE TO LIGHT PINK CHERRY RIPE BANANA

Application Number

ANDA211147

Brand Name

Azithromycin

Generic Name

Azithromycin

Product Ndc

70771-1425

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1422-1 Azithromycin for oral suspension, 300 mg 100 mg/5 mL Rx only NDC 70771-1423-2 Azithromycin for oral suspension, 600 mg 200 mg/5 mL Rx only NDC 70771-1424-2 Azithromycin for oral suspension, 900 mg 200 mg/5 mL Rx only NDC 70771-1425-2 Azithromycin for oral suspension, 1200 mg 200 mg/5 mL Rx only Azithromycin oral suspension Azithromycin oral suspension Azithromycin oral suspension Azithromycin oral suspension

Drug section

CME banner

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.