Lithium Carbonate Capsule, Gelatin Coated
NDC Package 70518-2345-2

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

Package Information

Lithium Carbonate capsules is a medication used to treat manic-depressive disorder (bipolar disorder). This formulation utilizes a capsule, gelatin coated delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-2345 and is authorized under FDA application NDA017812.

Identification & Billing

NDC Package Code
70518-2345-2
Package Description
30 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Product Code
70518-2345
11-Digit Billing Format
70518234502

Clinical Specifications

Proprietary Name
Lithium Carbonate
Non-Proprietary Name
Lithium Carbonate
Substance Name
Lithium Carbonate
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LITHIUM CARBONATE 600 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
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA017812
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-04-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70518-2345). Click a package code to view its specific billing and regulatory data.

70518-2345-0
100 POUCH in 1 BOX / 1 CAPSULE, GELATIN COATED in 1 POUCH (70518-2345-1)

* 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 70518-2345-2 identifies a specific commercial package of 30 capsule, gelatin coated in 1 blister pack of Lithium Carbonate, a human prescription drug labeled by Remedyrepack Inc.. This capsule, gelatin coated 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 Remedyrepack Inc. on October 04, 2019. 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 Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518234502. 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 (5-4-1)
70518-2345-2
11-Digit CMS (5-4-2)
70518-2345-02

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