This site is intended for healthcare professionals
FDA Hero  Banner - Multi-coloured pills and tablets
FDA Drug information

ACETYLCYSTEINE

Read time: 1 mins
Marketing start date: 28 Apr 2024

Summary of product characteristics


Effective Time

20221017

Version

3

Spl Product Data Elements

ACETYLCYSTEINE acetylcysteine ACETYLCYSTEINE ACETYLCYSTEINE EDETATE DISODIUM NITROGEN SODIUM HYDROXIDE WATER

Application Number

ANDA208166

Brand Name

ACETYLCYSTEINE

Generic Name

acetylcysteine

Product Ndc

70771-1412

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL – Vial Label NDC 70771-1412-1 Acetylcysteine Injection 6 g/30 mL (200 mg/mL) MUST BE FURTHER DILUTED PRIOR TO INTRAVENOUS USE 30 mL Sterile Rx only vial label

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.

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.