Drugplain

Isosorbide Dinitrate 40 mg/1

isosorbide dinitrate · TABLET · Oceanside Pharmaceuticals

8 Recalls on Record
Plain English

Isosorbide Dinitrate is a tablet containing isosorbide dinitrate at 40 mg/1, taken oral. Manufactured by Oceanside Pharmaceuticals.

Key Facts

Brand Name
Isosorbide Dinitrate
Generic Name
isosorbide dinitrate
NDC Code (Product)
68682-192
Manufacturer
Oceanside Pharmaceuticals
Strength
40 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
NDA012093
Drug Class
Nitrate Vasodilator [EPC]
Marketing Start
03/02/2020

Recall History

8 Recalls on Record
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated
Class II11/02/2018

Sandoz Inc

Cross Contamination with Other Products

TerminatedVoluntary: Firm initiated
Class II11/02/2018

Sandoz Inc

Cross Contamination with Other Products

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: CILOSTAZOL, Tablet, 100 mg, NDC 00054004421, Pedigree: W003470, EXP: 6/20/2014; PERPHENAZINE, Tablet, 8 mg, NDC 00630506221, Pedigree: AD54605_1, EXP: 4/30/2014.

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD22845_10, EXP: 5/2/2014; CALCITRIOL, Capsule, 0.5 mcg, NDC 63304024001, Pedigree: AD32757_10, EXP: 5/14/2014.

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling:Label Mixup; ISOSORBIDE DINITRATE ER Tablet, 40 mg may be potentially mislabeled as CILOSTAZOL, Tablet, 50 mg, NDC 60505252101, Pedigree: AD21811_7, EXP: 5/1/2014.

TerminatedVoluntary: Firm initiated
Class II11/02/2018

Sandoz Inc

Cross Contamination with Other Products

TerminatedVoluntary: Firm initiated
Class II11/02/2018

Sandoz Inc

Cross Contamination with Other Products

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

dyspnoea893 reports
nausea784 reports
diarrhoea739 reports
fatigue728 reports
dizziness718 reports
vomiting654 reports
chest pain648 reports
myocardial infarction604 reports
pain603 reports
headache593 reports

Frequently Asked Questions

What is Isosorbide Dinitrate used for?

Isosorbide Dinitrate contains isosorbide dinitrate. It is a tablet taken oral. Consult your doctor for specific uses.

Is Isosorbide Dinitrate a controlled substance?

Isosorbide Dinitrate is not classified as a controlled substance by the DEA.

What is the generic name for Isosorbide Dinitrate?

The generic name for Isosorbide Dinitrate is isosorbide dinitrate. There are 3 other brand versions of isosorbide dinitrate.

What is the NDC code for Isosorbide Dinitrate 40 mg/1?

The NDC (National Drug Code) for Isosorbide Dinitrate 40 mg/1 is 68682-192, listed by Oceanside Pharmaceuticals.

Product NDC

68682-192

Package NDC

68682-192-01

Other Isosorbide Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)