Misoprostol
NDC Package 70710-1007-8

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 70710-1007 and is authorized under FDA application ANDA210201.

Identification & Billing

NDC Package Code
70710-1007-8
Package Description
120 TABLET in 1 BOTTLE
Product Code
70710-1007
11-Digit Billing Format
70710100708

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
Zydus Pharmaceuticals Usa Inc.
FDA Application #
ANDA210201
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-14-2020
End Marketing Date
01-10-2023
Listing Expiration
01-10-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70710-1007). Click a package code to view its specific billing and regulatory data.

70710-1007-1
100 TABLET in 1 BOTTLE
70710-1007-4
10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK (70710-1007-2)
70710-1007-6
60 TABLET in 1 BOTTLE

* 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 70710-1007-8 identifies a specific commercial package of 120 tablet in 1 bottle of Misoprostol, labeled by Zydus Pharmaceuticals Usa 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 Zydus Pharmaceuticals Usa Inc. on January 14, 2020. The current certification is valid through January 10, 2023.

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 Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710100708. 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 (5-4-1)
70710-1007-8
11-Digit CMS (5-4-2)
70710-1007-08

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