Lithostat Tablet
NDC Package 0178-0500-01

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

Package Information

Lithostat (acetohydroxamic acid) tablets is a medication used with antibiotics and/or surgery to treat types of bladder infections that are caused by certain bacteria. This formulation utilizes a tablet delivery system. Marketed by Mission Pharmacal Company, this product is identified by NDC 0178-0500 and is authorized under FDA application NDA018749.

Identification & Billing

NDC Package Code
0178-0500-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
0178-0500
11-Digit Billing Format
00178050001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lithostat
Non-Proprietary Name
Acetohydroxamic Acid
Substance Name
Acetohydroxamic Acid
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)
ACETOHYDROXAMIC ACID 250 mg/1
Pharmacologic Class
Usage Information
This medication is used with antibiotics and/or surgery to treat types of bladder infections that are caused by certain bacteria. These bacteria cause the level of ammonia in the urine to become too high. This effect can lead to a certain type of kidney stone (struvite). This medication works by stopping the bacteria from making the ammonia. The decreased levels of ammonia can slow the growth of the kidney stones and make the antibiotic work better on your infection.

Regulatory & Marketing

Labeler Name
Mission Pharmacal Company
Product Type
Human Prescription Drug
FDA Application #
NDA018749
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-31-1983
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 0178-0500-01 identifies a specific commercial package of 100 tablet in 1 bottle of Lithostat, a human prescription drug labeled by Mission Pharmacal Company. This tablet is formulated for oral use and contains acetohydroxamic acid 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 Mission Pharmacal Company on May 31, 1983. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used with antibiotics and/or surgery to treat types of bladder infections that are caused by certain bacteria. These bacteria cause the level of ammonia in the urine to become too high. This effect can lead to a certain type of kidney stone (struvite). This medication works by stopping the bacteria from making the ammonia. The decreased levels of ammonia can slow the growth of the kidney stones and make the antibiotic work better on your infection.

How is this Mission Pharmacal Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00178050001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
0178-0500-01
11-Digit CMS (5-4-2)
00178-0500-01

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