Metoprolol Succinate Tablet, Extended Release
NDC Package 69097-409-02

11-digit billing NDC: 69097040902
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, extended release delivery system. Marketed by Cipla Usa Inc., this product is identified by NDC 69097-409 and is authorized under FDA application ANDA207465.

Identification & Billing

NDC Package Code
69097-409-02
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
69097-409
11-Digit Billing Format
69097040902
RxNorm Crosswalk
  • RxCUI: 866412 - metoprolol succinate 100 MG 24HR Extended Release Oral Tablet
  • RxCUI: 866412 - 24 HR metoprolol succinate 100 MG Extended Release Oral Tablet
  • RxCUI: 866412 - 24 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral Tablet
  • RxCUI: 866412 - metoprolol succinate 100 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 866419 - metoprolol succinate 200 MG 24HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Metoprolol Succinate
Non-Proprietary Name
Metoprolol Succinate
Substance Name
Metoprolol Succinate
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METOPROLOL SUCCINATE 200 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 (eg, 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
Cipla Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207465
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-25-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69097-409). Click a package code to view its specific billing and regulatory data.

69097-409-07
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
69097-409-15
1000 TABLET, 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 69097-409-02 identifies a specific commercial package of 30 tablet, extended release in 1 bottle of Metoprolol Succinate, a human prescription drug labeled by Cipla Usa Inc.. This tablet, 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 Cipla Usa Inc. on March 25, 2019. The current certification is valid through December 31, 2026.

How is this Cipla Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69097040902. 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)
69097-409-02
11-Digit CMS (5-4-2)
69097-0409-02

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