Butorphanol Tartrate Powder
NDC Package 84644-005-00

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 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.

Butorphanol Tartrate powders is a medication used to treat moderate to severe pain, including pain from surgery, muscle pain, and migraine headaches. This formulation utilizes a powder delivery system. Marketed by Tapi Czech Industries S.r.o., this product is identified by NDC 84644-005.

Identification & Billing

NDC Package Code
84644-005-00
Package Description
1 kg in 1 CARTON
Product Code
84644-005
11-Digit Billing Format
84644000500

Clinical Specifications

Proprietary Name
Butorphanol Tartrate
Non-Proprietary Name
Butorphanol Tartrate
Substance Name
Butorphanol Tartrate
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)
BUTORPHANOL TARTRATE 100 kg/100kg
Usage Information
This medication is used to treat moderate to severe pain, including pain from surgery, muscle pain, and migraine headaches. Butorphanol is an opioid pain reliever similar to morphine. It acts on certain centers in the brain to give you pain relief. Butorphanol can also block the effects of opioids and can cause withdrawal symptoms in people dependent on opioids. If possible, people who have recently used opioids in high doses or for a long time should not use butorphanol. (See also Side Effects section.)
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Tapi Czech Industries S.r.o.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-25-2013
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 84644-005-00 identifies a specific commercial package of 1 kg in 1 carton of Butorphanol Tartrate (UNFINISHED drug), a bulk ingredient labeled by Tapi Czech Industries S.r.o.. This powder is formulated for use and contains butorphanol tartrate 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 Tapi Czech Industries S.r.o. on February 25, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat moderate to severe pain, including pain from surgery, muscle pain, and migraine headaches. Butorphanol is an opioid pain reliever similar to morphine. It acts on certain centers in the brain to give you pain relief. Butorphanol can also block the effects of opioids and can cause withdrawal symptoms in people dependent on opioids. If possible, people who have recently used opioids in high doses or for a long time should not use butorphanol. (See also Side Effects section.)

How is this Tapi Czech Industries S.r.o. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84644000500. 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)
84644-005-00
11-Digit CMS (5-4-2)
84644-0005-00

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