Methyldopa
NDC Package 0378-0421-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Methyldopa is a medication used alone or with other medications to treat high blood pressure (hypertension). Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-0421 and is authorized under FDA application ANDA070076.

Identification & Billing

NDC Package Code
0378-0421-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
0378-0421
11-Digit Billing Format
00378042101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Methyldopa
Dosage Form
-
Usage Information
This medication is used alone or with other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Methyldopa works by relaxing blood vessels so blood can flow more easily.

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
FDA Application #
ANDA070076
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-18-1985
End Marketing Date
08-31-2020
Listing Expiration
08-31-2020
Exclude Flag
D
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 0378-0421-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Methyldopa, labeled by Mylan Pharmaceuticals Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Mylan Pharmaceuticals Inc. on April 18, 1985. The current certification is valid through August 31, 2020.

What are the primary indications for this medication?

This medication is used alone or with other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Methyldopa works by relaxing blood vessels so blood can flow more easily.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378042101. 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)
0378-0421-01
11-Digit CMS (5-4-2)
00378-0421-01

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