Verapamil Hydrochloride Capsule, Extended Release
NDC Package 0378-6380-01

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

Package Information

Verapamil Hydrochloride capsules is verapamil hydrochloride extended-release capsules are indicated for the treatment of hypertension, to lower blood pressure. This formulation utilizes a capsule, extended release delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-6380 and is authorized under FDA application ANDA075138.

Identification & Billing

NDC Package Code
0378-6380-01
Package Description
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
0378-6380
11-Digit Billing Format
00378638001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 897612 - verapamil HCl 120 MG 24HR Extended Release Oral Capsule
  • RxCUI: 897612 - 24 HR verapamil hydrochloride 120 MG Extended Release Oral Capsule
  • RxCUI: 897612 - verapamil hydrochloride 120 MG 24HR Extended Release Oral Capsule
  • RxCUI: 897618 - verapamil HCl 180 MG 24HR Extended Release Oral Capsule
  • RxCUI: 897618 - 24 HR verapamil hydrochloride 180 MG Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Verapamil Hydrochloride
Non-Proprietary Name
Verapamil Hydrochloride
Substance Name
Verapamil Hydrochloride
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VERAPAMIL HYDROCHLORIDE 180 mg/1
Pharmacologic Class
Usage Information
Verapamil hydrochloride extended-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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 this drug. 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.

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA075138
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-20-1999
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 0378-6380-01 identifies a specific commercial package of 100 capsule, extended release in 1 bottle, plastic of Verapamil Hydrochloride, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This capsule, extended release is formulated for oral use and contains verapamil hydrochloride 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 Mylan Pharmaceuticals Inc. on May 20, 1999. The current certification is valid through December 31, 2026.

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378638001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (4-4-2)
0378-6380-01
11-Digit CMS (5-4-2)
00378-6380-01

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