Lithium Carbonate Tablet, Extended Release
NDC Package 68084-655-01

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

Package Information

Lithium Carbonate tablets is a medication used to treat manic-depressive disorder (bipolar disorder). This formulation utilizes a tablet, extended release delivery system. Marketed by American Health Packaging, this product is identified by NDC 68084-655 and is authorized under FDA application ANDA076691.

Identification & Billing

NDC Package Code
68084-655-01
Package Description
100 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-655-11)
Product Code
68084-655
11-Digit Billing Format
68084065501
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
Lithium Carbonate
Non-Proprietary Name
Lithium Carbonate
Substance Name
Lithium Carbonate
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LITHIUM CARBONATE 450 mg/1
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
American Health Packaging
Product Type
Human Prescription Drug
FDA Application #
ANDA076691
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-03-2014
Listing Expiration
12-31-2026
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 68084-655-01 identifies a specific commercial package of 100 blister pack in 1 box, unit-dose / 1 tablet, extended release in 1 blister pack (68084-655-11) of Lithium Carbonate, a human prescription drug labeled by American Health Packaging. This tablet, extended release is formulated for oral use and contains lithium carbonate 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 American Health Packaging on January 03, 2014. The current certification is valid through December 31, 2026.

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 American Health Packaging product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68084065501. 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 (5-3-2)
68084-655-01
11-Digit CMS (5-4-2)
68084-0655-01

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