Butorphanol Tartrate Spray
NDC Package 60505-0813-1

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

Package Information

Butorphanol Tartrate sprays is a medication used to treat moderate to severe pain, including pain from surgery, muscle pain, and migraine headaches. This formulation utilizes a spray delivery system. Marketed by Apotex Corp., this product is identified by NDC 60505-0813 and is authorized under FDA application ANDA075499.

Identification & Billing

NDC Package Code
60505-0813-1
Package Description
1 BOTTLE, SPRAY in 1 CONTAINER / 2.5 mL in 1 BOTTLE, SPRAY
Product Code
60505-0813
11-Digit Billing Format
60505081301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 886634 - butorphanol tartrate 10 MG/mL Metered Dose Nasal Spray
  • RxCUI: 886634 - butorphanol tartrate 1 MG/ACTUAT Metered Dose Nasal Spray

Clinical Specifications

Proprietary Name
Butorphanol Tartrate
Non-Proprietary Name
Butorphanol Tartrate
Substance Name
Butorphanol Tartrate
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
BUTORPHANOL TARTRATE 10 mg/mL
Pharmacologic Class
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
Apotex Corp.
Product Type
Human Prescription Drug
FDA Application #
ANDA075499
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-04-2002
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 60505-0813-1 identifies a specific commercial package of 1 bottle, spray in 1 container / 2.5 ml in 1 bottle, spray of Butorphanol Tartrate, a human prescription drug labeled by Apotex Corp.. This spray is formulated for nasal 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 Apotex Corp. on December 04, 2002. 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 Apotex Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60505081301. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
60505-0813-1
11-Digit CMS (5-4-2)
60505-0813-01

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