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FDA Drug information

ACETYLCYSTEINE

Read time: 1 mins
Marketing start date: 27 Dec 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

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