Drugplain

amlodipine,valsartan and hydrochlorothiazide 10 mg/1

amlodipine,valsartan and hydrochlorothiazide · TABLET, FILM COATED · Macleods Pharmaceuticals Limited

9 Recalls on Record
Plain English

amlodipine,valsartan and hydrochlorothiazide is a tablet, film coated containing amlodipine,valsartan and hydrochlorothiazide at 10 mg/1, taken oral. Manufactured by Macleods Pharmaceuticals Limited.

Key Facts

Brand Name
amlodipine,valsartan and hydrochlorothiazide
Generic Name
amlodipine,valsartan and hydrochlorothiazide
NDC Code (Product)
33342-287
Manufacturer
Macleods Pharmaceuticals Limited
Strength
10 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA207299
Drug Class
Thiazide Diuretic [EPC]; Angiotensin 2 Receptor Blocker [EPC]
Marketing Start
01/06/2025

Recall History

9 Recalls on Record
Class II08/17/2018

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

OngoingVoluntary: Firm initiated
Class II11/27/2018

Teva Pharmaceuticals USA

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

OngoingVoluntary: Firm initiated
Class II08/17/2018

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

OngoingVoluntary: Firm initiated
Class II08/17/2018

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

OngoingVoluntary: Firm initiated
Class II11/27/2018

Teva Pharmaceuticals USA

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

OngoingVoluntary: Firm initiated
Class II11/27/2018

Teva Pharmaceuticals USA

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

OngoingVoluntary: Firm initiated
Class II11/27/2018

Teva Pharmaceuticals USA

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

OngoingVoluntary: Firm initiated
Class II08/17/2018

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

OngoingVoluntary: Firm initiated
Class II08/17/2018

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

OngoingVoluntary: Firm initiated

Frequently Asked Questions

What is amlodipine,valsartan and hydrochlorothiazide used for?

amlodipine,valsartan and hydrochlorothiazide contains amlodipine,valsartan and hydrochlorothiazide. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is amlodipine,valsartan and hydrochlorothiazide a controlled substance?

amlodipine,valsartan and hydrochlorothiazide is not classified as a controlled substance by the DEA.

What is the generic name for amlodipine,valsartan and hydrochlorothiazide?

The generic name for amlodipine,valsartan and hydrochlorothiazide is amlodipine,valsartan and hydrochlorothiazide. There are no other listed brand versions of amlodipine,valsartan and hydrochlorothiazide.

What is the NDC code for amlodipine,valsartan and hydrochlorothiazide 10 mg/1?

The NDC (National Drug Code) for amlodipine,valsartan and hydrochlorothiazide 10 mg/1 is 33342-287, listed by Macleods Pharmaceuticals Limited.

Product NDC

33342-287

Package NDC

33342-287-07

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

Data from openFDA · Public domain (CC0 1.0)