Misoprostol Tablet
NDC Package 54348-148-01
Package Information
Misoprostol tablets 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. This formulation utilizes a tablet delivery system. Marketed by Pharmpak, Inc., this product is identified by NDC 54348-148 and is authorized under FDA application ANDA091667.
Identification & Billing
- RxCUI: 317128 - miSOPROStol 200 MCG Oral Tablet
- RxCUI: 317128 - misoprostol 0.2 MG Oral Tablet
- RxCUI: 317128 - misoprostol 200 MCG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 54348 - Pharmpak, Inc.
- 54348-148 - Misoprostol
- 54348-148-01 - 1 BOTTLE in 1 BOX / 1 TABLET in 1 BOTTLE
- 54348-148 - Misoprostol
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 (54348-148). Click a package code to view its specific billing and regulatory data.
* 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 54348-148-01 identifies a specific commercial package of 1 bottle in 1 box / 1 tablet in 1 bottle of Misoprostol, a human prescription drug labeled by Pharmpak, 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 Pharmpak, Inc. on July 10, 2019. The current certification is valid through December 31, 2026.
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 Pharmpak, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 54348014801. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
