Metoprolol Succinate Tablet, Film Coated, Extended Release
NDC Package 82009-113-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Metoprolol Succinate tablets is a medication a beta-blocker used to treat chest pain (angina), heart failure, and high blood pressure. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Quallent Pharmaceuticals Health Llc, this product is identified by NDC 82009-113 and is authorized under FDA application ANDA090617.

Identification & Billing

NDC Package Code
82009-113-05
Package Description
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
82009-113
11-Digit Billing Format
82009011305
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA
RxNorm Crosswalk
  • RxCUI: 866427 - metoprolol succinate 25 MG 24HR Extended Release Oral Tablet
  • RxCUI: 866427 - 24 HR metoprolol succinate 25 MG Extended Release Oral Tablet
  • RxCUI: 866427 - 24 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral Tablet
  • RxCUI: 866427 - metoprolol succinate 25 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 866436 - metoprolol succinate 50 MG 24HR 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 25 mg/1
Pharmacologic Class
Usage Information
This medication is a beta-blocker used to treat chest pain (angina), heart failure, and high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This drug works by blocking the action of certain natural chemicals in your body (such as epinephrine) that affect the heart and blood vessels. This lowers heart rate, blood pressure, and strain on the heart.

Regulatory & Marketing

Labeler Name
Quallent Pharmaceuticals Health 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
07-20-2023
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 82009-113-05 identifies a specific commercial package of 500 tablet, film coated, extended release in 1 bottle of Metoprolol Succinate, a human prescription drug labeled by Quallent Pharmaceuticals Health Llc. 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 Quallent Pharmaceuticals Health Llc on July 20, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is a beta-blocker used to treat chest pain (angina), heart failure, and high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. This drug works by blocking the action of certain natural chemicals in your body (such as epinephrine) that affect the heart and blood vessels. This lowers heart rate, blood pressure, and strain on the heart.

How is this Quallent Pharmaceuticals Health Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82009011305. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 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)
82009-113-05
11-Digit CMS (5-4-2)
82009-0113-05

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