Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.
NDC Package Code:
72189-012-90
Package Description:
90 TABLET, FILM COATED in 1 BOTTLE
Proprietary Name:
Losartan Potassium And Hydrochlorothiazide
Non-Proprietary Name:
Losartan Potassium And Hydrochlorothiazide
Substance Name:
Hydrochlorothiazide; Losartan Potassium
Usage Information:
1.1 HypertensionLosartan potassium and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan and hydrochlorothiazide.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients [see Clinical Studies (14) and Dosage and Administration (2.1)].
Losartan potassium and hydrochlorothiazide tablets may be administered with other antihypertensive agents.
1.2 Hypertensive Patients with Left Ventricular HypertrophyLosartan potassium and hydrochlorothiazide tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3), and Dosage and Administration (2.2)].
11-Digit NDC Billing Format:
72189001290
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
90 EA
NDC to RxNorm Crosswalk:
RxCUI: 979464 - losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletRxCUI: 979464 - hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletRxCUI: 979464 - HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletRxCUI: 979464 - HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletRxCUI: 979464 - HCTZ 12.5 MG / losartan potassium 100 MG Oral Tablet Product Type:
Human Prescription Drug
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s):
Oral - Administration to or by way of the mouth.
FDA Application Number:
ANDA091629
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
07-17-2019
Listing Expiration Date:
12-31-2024
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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