Misoprostol Tablet
NDC Package 43393-024-04

11-digit billing NDC: 43393002404 · Billing unit: EA · 4 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Misoprostol tablets are indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. This formulation utilizes a tablet delivery system. Marketed by Genbiopro, Inc., this product is identified by NDC 43393-024 and is authorized under FDA application ANDA210201.

Identification & Billing

NDC Package Code
43393-024-04
Package Description
4 TABLET in 1 BOTTLE
Product Code
43393-024
11-Digit Billing Format
43393002404
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Misoprostol
Non-Proprietary Name
Misoprostol
Substance Name
Misoprostol
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MISOPROSTOL 200 ug/1
Pharmacologic Class
Usage Information
Misoprostol tablets are indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months’ duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.

Regulatory & Marketing

Labeler Name
Genbiopro, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210201
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-30-2024
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 43393-024-04 identifies a specific commercial package of 4 tablet in 1 bottle of Misoprostol, a human prescription drug labeled by Genbiopro, Inc.. This tablet is formulated for oral use and contains misoprostol 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 Genbiopro, Inc. on September 30, 2024. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43393002404. 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)
43393-024-04
11-Digit CMS (5-4-2)
43393-0024-04

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