Butorphanol Tartrate Injection, Solution
NDC Package 0143-9867-10

11-digit billing NDC: 00143986710 · Billing unit: ML · 1 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Butorphanol Tartrate injection is indicated:as a preoperative or pre-anesthetic medicationas a supplement to balanced anesthesiafor the relief of pain during labor, andfor the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Butorphanol Tartrate Injection for use in patients for whom alternative treatment options [e.g. This formulation utilizes a injection, solution delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0143-9867 and is authorized under FDA application ANDA078400.

Identification & Billing

NDC Package Code
0143-9867-10
Package Description
1 mL in 1 VIAL, SINGLE-DOSE
Product Code
0143-9867
11-Digit Billing Format
00143986710
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
1 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Butorphanol Tartrate
Non-Proprietary Name
Butorphanol Tartrate
Substance Name
Butorphanol Tartrate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
BUTORPHANOL TARTRATE 2 mg/mL
Pharmacologic Class
Usage Information
Butorphanol Tartrate Injection is indicated:as a preoperative or pre-anesthetic medicationas a supplement to balanced anesthesiafor the relief of pain during labor, andfor the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Butorphanol Tartrate Injection for use in patients for whom alternative treatment options [e.g. non-opioid analgesics]Have not been tolerated, or are not expected to be toleratedHave not provided adequate analgesia, or are not expected to provide adequate analgesia
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078400
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2009
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 0143-9867-10 identifies a specific commercial package of 1 ml in 1 vial, single-dose of Butorphanol Tartrate, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 1 billable units per package. This injection, solution is formulated for intramuscular; intravenous 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 Hikma Pharmaceuticals Usa Inc. on May 01, 2009. The current certification is valid through December 31, 2026.

How is this Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00143986710. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 1 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 (4-4-2)
0143-9867-10
11-Digit CMS (5-4-2)
00143-9867-10

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