Drugplain

Fludrocortisone Acetate .1 mg/1

FLUDROCORTISONE ACETATE · TABLET · Amneal Pharmaceuticals of New York LLC

1 Recall on Record
Plain English

Fludrocortisone Acetate is a tablet containing fludrocortisone acetate at .1 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals of New York LLC.

Key Facts

Brand Name
Fludrocortisone Acetate
Generic Name
FLUDROCORTISONE ACETATE
NDC Code (Product)
0115-7033
Manufacturer
Amneal Pharmaceuticals of New York LLC
Strength
.1 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA040431
Marketing Start
03/18/2002

Recall History

1 Recall on Record
Class II06/28/2024

Teva Pharmaceuticals USA, Inc

Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue150 reports
fall147 reports
dizziness139 reports
nausea131 reports
death129 reports
diarrhoea126 reports
headache109 reports
off label use105 reports
pneumonia100 reports
hypotension96 reports

Frequently Asked Questions

What is Fludrocortisone Acetate used for?

Fludrocortisone Acetate contains FLUDROCORTISONE ACETATE. It is a tablet taken oral. Consult your doctor for specific uses.

Is Fludrocortisone Acetate a controlled substance?

Fludrocortisone Acetate is not classified as a controlled substance by the DEA.

What is the generic name for Fludrocortisone Acetate?

The generic name for Fludrocortisone Acetate is FLUDROCORTISONE ACETATE. There are 3 other brand versions of FLUDROCORTISONE ACETATE.

What is the NDC code for Fludrocortisone Acetate .1 mg/1?

The NDC (National Drug Code) for Fludrocortisone Acetate .1 mg/1 is 0115-7033, listed by Amneal Pharmaceuticals of New York LLC.

Product NDC

0115-7033

Package NDC

0115-7033-01

Other Fludrocortisone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)