Mifepristone Tablet, Film Coated
NDC Package 0591-4390-96

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

Package Information

Mifepristone tablets is mifepristone (also known as RU 486) is used to cause an abortion during the early part of a pregnancy. This formulation utilizes a tablet, film coated delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-4390 and is authorized under FDA application ANDA211436.

Identification & Billing

NDC Package Code
0591-4390-96
Package Description
28 TABLET, FILM COATED in 1 BOTTLE
Product Code
0591-4390
11-Digit Billing Format
00591439096
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
28 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mifepristone
Non-Proprietary Name
Mifepristone
Substance Name
Mifepristone
Dosage Form
Tablet, Film Coated - 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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MIFEPRISTONE 300 mg/1
Pharmacologic Class
Usage Information
Mifepristone (also known as RU 486) is used to cause an abortion during the early part of a pregnancy. It is used up to week 10 of pregnancy (up to 70 days after the first day of your last menstrual period). Mifepristone blocks a natural substance (progesterone) that is needed for your pregnancy to continue. It is usually used together with another medicine called misoprostol. Mifepristone must not be used if you have a rare abnormal pregnancy that is outside the womb (ectopic pregnancy). It will not cause an abortion in this case. It may cause an ectopic pregnancy to rupture, resulting in very serious bleeding.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211436
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-19-2024
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 0591-4390-96 identifies a specific commercial package of 28 tablet, film coated in 1 bottle of Mifepristone, a human prescription drug labeled by Actavis Pharma, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 28 billable units per package. This tablet, film coated is formulated for oral use and contains mifepristone 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 Actavis Pharma, Inc. on January 19, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Mifepristone (also known as RU 486) is used to cause an abortion during the early part of a pregnancy. It is used up to week 10 of pregnancy (up to 70 days after the first day of your last menstrual period). Mifepristone blocks a natural substance (progesterone) that is needed for your pregnancy to continue. It is usually used together with another medicine called misoprostol. Mifepristone must not be used if you have a rare abnormal pregnancy that is outside the womb (ectopic pregnancy). It will not cause an abortion in this case. It may cause an ectopic pregnancy to rupture, resulting in very serious bleeding.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591439096. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 28 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)
0591-4390-96
11-Digit CMS (5-4-2)
00591-4390-96

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