Levodopa Powder
NDC Package 49452-2680-2

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

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Levodopa powders is a medication used when needed to treat the return of Parkinson's symptoms (known as OFF episodes) in people with Parkinson's disease who are treated with carbidopa/levodopa medicines. This formulation utilizes a powder delivery system. Marketed by Spectrum Laboratory Products, Inc., this product is identified by NDC 49452-2680.

Identification & Billing

NDC Package Code
49452-2680-2
Package Description
25 g in 1 BOTTLE
Product Code
49452-2680
11-Digit Billing Format
49452268002
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
25 GM

Clinical Specifications

Proprietary Name
Levodopa
Non-Proprietary Name
Levodopa
Substance Name
Levodopa
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
LEVODOPA 1 g/g
Usage Information
This medication is used when needed to treat the return of Parkinson's symptoms (known as OFF episodes) in people with Parkinson's disease who are treated with carbidopa/levodopa medicines. Parkinson's disease tends to worsen over time, and you may need extra levodopa from time to time to keep symptoms (such as shakiness, stiffness, difficulty moving) from returning. This medication does not replace your regular carbidopa/levodopa medicine. Keep taking your carbidopa/levodopa medicine regularly as directed by your doctor. Parkinson's disease is thought to be caused by too little of a naturally occurring substance (dopamine) in the brain. Levodopa changes into dopamine in the brain, helping to control movement.

Regulatory & Marketing

Labeler Name
Spectrum Laboratory Products, Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-01-1990
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (49452-2680). Click a package code to view its specific billing and regulatory data.

49452-2680-1
5 g in 1 BOTTLE
49452-2680-3
100 g in 1 BOTTLE
49452-2680-5
500 g in 1 BOTTLE
49452-2680-6
10000 g in 1 DRUM
49452-2680-7
25000 g in 1 DRUM

* 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 49452-2680-2 identifies a specific commercial package of 25 g in 1 bottle of Levodopa (UNFINISHED drug), a bulk ingredient labeled by Spectrum Laboratory Products, Inc.. This product is billed per "GM" gram and contains an estimated amount of 25 billable units per package. This powder is formulated for use and contains levodopa 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 Spectrum Laboratory Products, Inc. on April 01, 1990. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used when needed to treat the return of Parkinson's symptoms (known as OFF episodes) in people with Parkinson's disease who are treated with carbidopa/levodopa medicines. Parkinson's disease tends to worsen over time, and you may need extra levodopa from time to time to keep symptoms (such as shakiness, stiffness, difficulty moving) from returning. This medication does not replace your regular carbidopa/levodopa medicine. Keep taking your carbidopa/levodopa medicine regularly as directed by your doctor. Parkinson's disease is thought to be caused by too little of a naturally occurring substance (dopamine) in the brain. Levodopa changes into dopamine in the brain, helping to control movement.

How is this Spectrum Laboratory Products, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49452268002. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 25 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 (5-4-1)
49452-2680-2
11-Digit CMS (5-4-2)
49452-2680-02

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