NDC 63323-693

Acetylcysteine 100 mg per 1 mL solution

On the label: Fresenius Kabi, LLC.

India: 2

Where it's made

FactoryWhereRoleLast FDA inspection
Gland Pharma LimitedHyderabad, IndiaMakes it, makes the active ingredient, packages it and labels it Problems found, fixed voluntarilyJul 25, 2024 · 7 inspections
Gland Pharma LimitedHyderabad, IndiaMakes it, packages it and labels it Problems found, fixed voluntarilyJun 27, 2023 · 4 inspections

Product details

Generic drug
Acetylcysteine: every company that makes it
Form
solution, oral; respiratory (inhalation)
Strength
100 mg per 1 mL
Approval
ANDA ANDA204674
On the market since
Mar 31, 2014
Package NDCs
63323-693-10 63323-693-22
Official label
DailyMed (National Library of Medicine), updated Aug 15, 2024

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