Drugplain

captopril 12.5 mg/1

captopril · TABLET · AMICI PHARMACEUTICALS LLC

5 Recalls on Record
Plain English

captopril is a tablet containing captopril at 12.5 mg/1, taken oral. Manufactured by AMICI PHARMACEUTICALS LLC.

Key Facts

Brand Name
captopril
Generic Name
captopril
NDC Code (Product)
69292-522
Manufacturer
AMICI PHARMACEUTICALS LLC
Strength
12.5 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA074677
Drug Class
Angiotensin Converting Enzyme Inhibitor [EPC]
Marketing Start
08/20/2019

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 contains captopril. It is a tablet taken oral. Consult your doctor for specific uses.

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 12.5 mg/1?

The NDC (National Drug Code) for captopril 12.5 mg/1 is 69292-522, listed by AMICI PHARMACEUTICALS LLC.