Lithium
NDC Package 0054-8529-04

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.

Lithium is a medication used to treat manic-depressive disorder (bipolar disorder). Marketed by Roxane Laboratories, Inc, this product is identified by NDC 0054-8529 and is authorized under FDA application NDA018421.

Identification & Billing

NDC Package Code
0054-8529-04
Package Description
5 mL in 1 CUP, UNIT-DOSE
Product Code
0054-8529
11-Digit Billing Format
00054852904
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
5 ML

Clinical Specifications

Proprietary Name
Lithium
Dosage Form
-
Usage Information
This medication is used to treat manic-depressive disorder (bipolar disorder). It works to stabilize the mood and reduce extremes in behavior by restoring the balance of certain natural substances (neurotransmitters) in the brain. Some of the benefits of continued use of this medication include decreasing how often manic episodes occur and decreasing the symptoms of manic episodes, such as exaggerated feelings of well-being, feelings that others wish to harm you, irritability, anxiousness, rapid/loud speech, and aggressive/hostile behaviors.

Regulatory & Marketing

Labeler Name
Roxane Laboratories, Inc
FDA Application #
NDA018421
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-29-1982
End Marketing Date
06-02-2016
Listing Expiration
06-02-2016
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 0054-8529-04 identifies a specific commercial package of 5 ml in 1 cup, unit-dose of Lithium, labeled by Roxane Laboratories, Inc. This product is billed per "ML" milliliter and contains an estimated amount of 5 billable units per package. 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 Roxane Laboratories, Inc on April 29, 1982. The current certification is valid through June 02, 2016.

What are the primary indications for this medication?

This medication is used to treat manic-depressive disorder (bipolar disorder). It works to stabilize the mood and reduce extremes in behavior by restoring the balance of certain natural substances (neurotransmitters) in the brain. Some of the benefits of continued use of this medication include decreasing how often manic episodes occur and decreasing the symptoms of manic episodes, such as exaggerated feelings of well-being, feelings that others wish to harm you, irritability, anxiousness, rapid/loud speech, and aggressive/hostile behaviors.

How is this Roxane Laboratories, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054852904. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 5 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)
0054-8529-04
11-Digit CMS (5-4-2)
00054-8529-04

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