Drugplain

ampicillin and sulbactam 1 g/1

ampicillin and sulbactam · INJECTION, POWDER, FOR SOLUTION · Sagent Pharmaceuticals

10 Recalls on RecordCurrently in Shortage
Plain English

ampicillin and sulbactam is a injection, powder, for solution containing ampicillin and sulbactam at 1 g/1, taken intramuscular. Manufactured by Sagent Pharmaceuticals.

Key Facts

Brand Name
ampicillin and sulbactam
Generic Name
ampicillin and sulbactam
NDC Code (Product)
25021-142
Manufacturer
Sagent Pharmaceuticals
Strength
1 g/1
Dosage Form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR, INTRAVENOUS
Marketing Status
Application #
ANDA065406
Marketing Start
06/30/2010

Recall History

10 Recalls on Record
Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class I01/02/2018

Aurobindo Pharma Ltd.

Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.

TerminatedVoluntary: Firm initiated
Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II05/15/2023

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective78 reports
pyrexia71 reports
pneumonia49 reports
off label use46 reports
condition aggravated37 reports
sepsis31 reports
septic shock30 reports
acute kidney injury29 reports
dyspnoea29 reports
rash29 reports

Frequently Asked Questions

What is ampicillin and sulbactam used for?

ampicillin and sulbactam contains ampicillin and sulbactam. It is a injection, powder, for solution taken intramuscular. Consult your doctor for specific uses.

Is ampicillin and sulbactam a controlled substance?

ampicillin and sulbactam is not classified as a controlled substance by the DEA.

What is the generic name for ampicillin and sulbactam?

The generic name for ampicillin and sulbactam is ampicillin and sulbactam. There are 9 other brand versions of ampicillin and sulbactam.

What is the NDC code for ampicillin and sulbactam 1 g/1?

The NDC (National Drug Code) for ampicillin and sulbactam 1 g/1 is 25021-142, listed by Sagent Pharmaceuticals.

Product NDC

25021-142

Package NDC

25021-142-20

Other Ampicillin 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)