Misoprostol
NDC Package 43393-020-04

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.

Misoprostol is a medication used to prevent stomach ulcers while you take NSAIDs (e.g., aspirin, ibuprofen, naproxen), especially if you are at risk for developing ulcers or have a history of ulcers. Marketed by Genbiopro, Inc., this product is identified by NDC 43393-020 and is authorized under FDA application NDA019268.

Identification & Billing

NDC Package Code
43393-020-04
Package Description
4 TABLET in 1 BOTTLE
Product Code
43393-020
11-Digit Billing Format
43393002004
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA

Clinical Specifications

Proprietary Name
Misoprostol
Dosage Form
-
Usage Information
This medication is used to prevent stomach ulcers while you take NSAIDs (e.g., aspirin, ibuprofen, naproxen), especially if you are at risk for developing ulcers or have a history of ulcers. Misoprostol helps to decrease your risk of serious ulcer complications such as bleeding. This medication protects your stomach lining by lowering the amount of acid that comes in contact with it. This medication is also used in combination with another drug (mifepristone) to end a pregnancy (abortion).

Regulatory & Marketing

Labeler Name
Genbiopro, Inc.
FDA Application #
NDA019268
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
12-27-2009
End Marketing Date
07-31-2024
Listing Expiration
07-31-2024
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 43393-020-04 identifies a specific commercial package of 4 tablet in 1 bottle of Misoprostol, labeled by Genbiopro, 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 Genbiopro, Inc. on December 27, 2009. The current certification is valid through July 31, 2024.

What are the primary indications for this medication?

This medication is used to prevent stomach ulcers while you take NSAIDs (e.g., aspirin, ibuprofen, naproxen), especially if you are at risk for developing ulcers or have a history of ulcers. Misoprostol helps to decrease your risk of serious ulcer complications such as bleeding. This medication protects your stomach lining by lowering the amount of acid that comes in contact with it. This medication is also used in combination with another drug (mifepristone) to end a pregnancy (abortion).

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43393002004. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 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 (5-3-2)
43393-020-04
11-Digit CMS (5-4-2)
43393-0020-04

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