Meclofenamate Sodium Capsule
NDC Package 0378-3000-01

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

Package Information

Meclofenamate Sodium capsules is meclofenamate is used to relieve pain from various conditions (such as headache, muscle aches) and to decrease pain and blood loss from menstrual periods. This formulation utilizes a capsule delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-3000 and is authorized under FDA application ANDA071081.

Identification & Billing

NDC Package Code
0378-3000-01
Package Description
100 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
0378-3000
11-Digit Billing Format
00378300001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Meclofenamate Sodium
Non-Proprietary Name
Meclofenamate Sodium
Substance Name
Meclofenamate Sodium
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MECLOFENAMATE SODIUM 100 mg/1
Usage Information
Meclofenamate is used to relieve pain from various conditions (such as headache, muscle aches) and to decrease pain and blood loss from menstrual periods. It is also used to reduce fever and reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. Meclofenamate is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA071081
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-03-1986
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0378-3000-01 identifies a specific commercial package of 100 capsule in 1 bottle, plastic of Meclofenamate Sodium, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This capsule is formulated for oral use and contains meclofenamate sodium 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 September 03, 1986. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Meclofenamate is used to relieve pain from various conditions (such as headache, muscle aches) and to decrease pain and blood loss from menstrual periods. It is also used to reduce fever and reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. Meclofenamate is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378300001. 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)
0378-3000-01
11-Digit CMS (5-4-2)
00378-3000-01

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