Metoprolol Succinate Tablet, Film Coated, Extended Release
NDC Package 53401-009-60

11-digit billing NDC: 53401000960 · Billing unit: EA · 90 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Metoprolol Succinate tablets is metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 53401-009 and is authorized under FDA application ANDA090617.

Identification & Billing

NDC Package Code
53401-009-60
Package Description
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
53401-009
11-Digit Billing Format
53401000960
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk
  • RxCUI: 866436 - metoprolol succinate 50 MG 24HR Extended Release Oral Tablet
  • RxCUI: 866436 - 24 HR metoprolol succinate 50 MG Extended Release Oral Tablet
  • RxCUI: 866436 - 24 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral Tablet
  • RxCUI: 866436 - metoprolol succinate 50 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Metoprolol Succinate
Non-Proprietary Name
Metoprolol Succinate
Substance Name
Metoprolol Succinate
Dosage Form
Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METOPROLOL SUCCINATE 50 mg/1
Pharmacologic Class
Usage Information
Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers 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 metoprolol.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.Metoprolol succinate extended-release tablets may be administered with other antihypertensive agents.

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA090617
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-13-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53401-009). Click a package code to view its specific billing and regulatory data.

53401-009-30
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
53401-009-45
45 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
53401-009-53
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
53401-009-70
120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
53401-009-80
180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53401-009-60 identifies a specific commercial package of 90 tablet, film coated, extended release in 1 bottle of Metoprolol Succinate, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package. This tablet, film coated, extended release is formulated for oral use and contains metoprolol succinate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Aphena Pharma Solutions - Tennessee, Llc on January 13, 2026. The current certification is valid through December 31, 2027.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53401000960. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
53401-009-60
11-Digit CMS (5-4-2)
53401-0009-60

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.