Azithromycin dihydrate capsules

Pfizer Inc

Revision date : 2026-02-21

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GHS09
Health risk rating 1
Safety risk rating 1
Environmental risk rating 5

Note: Ingredients listed on restricted chemical lists

EC/CAS

200-559-2/63-42-3

Name of the chemical

Lactose C12H22O11

Concentration

>=20%

EC/CAS

232-679-6/9005-25-8

Name of the chemical

Starch

Concentration

*

EC/CAS

209-150-3

Name of the chemical

Aluminium, zinc, magnesium and calcium stearates

Concentration

*

General Information

Version

6.01

Revision date

2026-02-21

Product name

Azithromycin dihydrate capsules

Product name

Azithromycin dihydrate capsules

Identification on the label/Trade name

ZITHROMAX; AZENIL; AZITROCIN; ZETAMAX; ZITROMAX; ZITHROMAC

Chemical name

Mixture

1.2.1 Relevant identified uses

Pharmaceutical product used as antibiotic agent

Emergency telephone

1-800-424-9300, +1-703-527-3887

Icons in SDS

GHS09 M004 M009 M010 M017

Company Information

company name

Pfizer Inc

e-mail address of the competent person responsible for the Safety Data Sheet

pfizer-MSDS@pfizer.com

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H410

Hazard statements

Code

Statements

H410

Very toxic to aquatic life with long lasting effects

Section 2

SECTION 2: Hazards identification

OSHA Classification of the substance or mixture

2.3 Other hazards

Not applicable (HNOC) An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8). Azithromycin dihydrate Pfizer OEL TWA-8 Hr Sodium lauryl sulfate Pfizer OEL TWA-8 Hr PBT & vPvB 500 µg/m3 300 µg/m3 The product does not contain any substance(s) classified as PBT or vPvB. Endocrine Disruptor Information This product does not contain any known or suspected endocrine disruptors. Note This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace.

Signal word

Warning

Hazard statements

H410 - Very toxic to aquatic life with long lasting effects

Precautionary statements

P273 - Avoid release to the environment P391 - Collect spillage P501 - Dispose of contents/container in accordance with local, regional, national, and international regulations as applicable

2.1 Classification of the substance or mixture

GHS - Classification: Regulated according to Regulation (EC) 1272/2008 and/or other applicable regulations. Hazardous to the aquatic environment - acute Category 1 - (H400) Hazardous to the aquatic environment - chronic Category 1 - (H410) OSHA Classification Hazards not otherwise classified (HNOC) Not applicable Hazards classified under paragraph (d)(1)(ii) of 1910.1200 Not applicable

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