NDC Package 62332-759-30 Amlodipine And Atorvastatin

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

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Package Information

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:

62332-759-30

Package Description:

30 TABLET, FILM COATED in 1 BOTTLE

Product Code:

62332-759

Proprietary Name:

Amlodipine And Atorvastatin

Non-Proprietary Name:

Amlodipine And Atorvastatin

Substance Name:

Amlodipine Besylate; Atorvastatin Calcium Trihydrate

Usage Information:

Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.AmlodipineHypertension Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. 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 one 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. Amlodipine may be used alone or in combination with other antihypertensive agents.Coronary Artery Disease (CAD)Chronic Stable Angina Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents.Vasospastic Angina (Prinzmetal’s or Variant Angina) Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents.Angiographically Documented CAD In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.Atorvastatin Atorvastatin is indicated: • To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia

11-Digit NDC Billing Format:

62332075930

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

30 EA

NDC to RxNorm Crosswalk:

RxCUI: 404011 - amLODIPine besylate 5 MG / atorvastatin calcium 80 MG Oral Tablet
RxCUI: 404011 - amlodipine 5 MG / atorvastatin 80 MG Oral Tablet
RxCUI: 404011 - amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral Tablet
RxCUI: 404013 - amLODIPine besylate 10 MG / atorvastatin calcium 80 MG Oral Tablet
RxCUI: 404013 - amlodipine 10 MG / atorvastatin 80 MG Oral Tablet

Product Type:

Human Prescription Drug

Labeler Name:

Alembic Pharmaceuticals Inc.

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.

Active Ingredient(s):

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

ANDA217279

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

05-23-2025

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

62332 - Alembic Pharmaceuticals Inc.
- 62332-759 - Amlodipine And Atorvastatin
  - 62332-759-30 - 30 TABLET, FILM COATED in 1 BOTTLE

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.

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
62332-759-90	90 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 62332-759-30?

The NDC Packaged Code 62332-759-30 is assigned to a package of 30 tablet, film coated in 1 bottle of Amlodipine And Atorvastatin, a human prescription drug labeled by Alembic Pharmaceuticals Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 62332-759 included in the NDC Directory?

Yes, Amlodipine And Atorvastatin with product code 62332-759 is active and included in the NDC Directory. The product was first marketed by Alembic Pharmaceuticals Inc. on May 23, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 62332-759-30?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

What is the 11-digit format for NDC 62332-759-30?

The 11-digit format is 62332075930. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	62332-759-30	5-4-2	62332-0759-30

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