Lithium Solution
NDC Package 0121-1027-16

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

Package Information

Lithium solution is a medication used to treat manic-depressive disorder (bipolar disorder). This formulation utilizes a solution delivery system. Marketed by Pai Holdings, Llc Dba Pai Pharma, this product is identified by NDC 0121-1027 and is authorized under FDA application ANDA070755.

Identification & Billing

NDC Package Code
0121-1027-16
Package Description
500 mL in 1 BOTTLE
Product Code
0121-1027
11-Digit Billing Format
00121102716
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
500 ML
RxNorm Crosswalk
  • RxCUI: 756059 - lithium ion 8 MEQ in 5 mL Oral Solution
  • RxCUI: 756059 - lithium citrate 60 MG/ML Oral Solution
  • RxCUI: 756059 - lithium citrate eqv to lithium carbonate 300 MG per 5 ML (lithium ion 8 MEQ per 5 ML) Oral Syrup
  • RxCUI: 756059 - lithium ion 8 MEQ per 5 ML Oral Syrup

Clinical Specifications

Proprietary Name
Lithium
Non-Proprietary Name
Lithium
Substance Name
Lithium Citrate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LITHIUM CITRATE 8 meq/5mL
Pharmacologic Class
Mood Stabilizer - [EPC] (Established Pharmacologic Class)
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
Pai Holdings, Llc Dba Pai Pharma
Product Type
Human Prescription Drug
FDA Application #
ANDA070755
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-14-2026
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 0121-1027-16 identifies a specific commercial package of 500 ml in 1 bottle of Lithium, a human prescription drug labeled by Pai Holdings, Llc Dba Pai Pharma. This product is billed per "ML" milliliter and contains an estimated amount of 500 billable units per package. This solution is formulated for oral use and contains lithium citrate 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 Pai Holdings, Llc Dba Pai Pharma on April 14, 2026. The current certification is valid through December 31, 2027.

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 Pai Holdings, Llc Dba Pai Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00121102716. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 500 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)
0121-1027-16
11-Digit CMS (5-4-2)
00121-1027-16

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