Drugplain

captopril 100 mg/1

captopril · TABLET · Method Pharmaceuticals LLC

5 Recalls on Record
Plain English

Captopril is a prescription tablet taken by mouth that belongs to a class of drugs called ACE inhibitors, which are used to treat high blood pressure and heart failure. It works by relaxing blood vessels to help your heart pump blood more effectively and reduce strain on your cardiovascular system.

Key Facts

Brand Name
captopril
Generic Name
captopril
NDC Code (Product)
58657-738
Manufacturer
Method Pharmaceuticals LLC
Strength
100 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA074677
Drug Class
Angiotensin Converting Enzyme Inhibitor [EPC]
Marketing Start
06/15/2024

Recall History

5 Recalls on Record
Class II05/22/2015

Blenheim Pharmacal, Inc.

cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure

TerminatedVoluntary: Firm initiated
Class II04/22/2015

Wockhardt Usa Inc.

CGMP Deviations: Firm did not adequately investigate customer complaints.

TerminatedVoluntary: Firm initiated
Class II04/22/2015

Wockhardt Usa Inc.

CGMP Deviations: Firm did not adequately investigate customer complaints.

TerminatedVoluntary: Firm initiated
Class II04/22/2015

Wockhardt Usa Inc.

CGMP Deviations: Firm did not adequately investigate customer complaints.

TerminatedVoluntary: Firm initiated
Class II03/12/2015

Wockhardt Usa Inc.

Failed Tablet/Capsule Specifications: out of specification for thickness.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is captopril used for?

Captopril is a prescription tablet taken by mouth that belongs to a class of drugs called ACE inhibitors, which are used to treat high blood pressure and heart failure. It works by relaxing blood vessels to help your heart pump blood more effectively and reduce strain on your cardiovascular system.

Is captopril a controlled substance?

captopril is not classified as a controlled substance by the DEA.

What is the generic name for captopril?

The generic name for captopril is captopril. There are 9 other brand versions of captopril.

What is the NDC code for captopril 100 mg/1?

The NDC (National Drug Code) for captopril 100 mg/1 is 58657-738, listed by Method Pharmaceuticals LLC.