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  5. NDC Package Code: 57218-954-01 Butorphanol Tartrate

NDC Package 57218-954-01 Butorphanol Tartrate

Powder - View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
57218-954-01
Package Description:
25 kg in 1 DRUM
Product Code:
57218-954
Non-Proprietary Name:
Butorphanol Tartrate
Substance Name:
Butorphanol Tartrate
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.)
11-Digit NDC Billing Format:
57218095401
Product Type:
Bulk Ingredient
Labeler Name:
Malladi Drugs And Pharmaceuticals Limited
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 1 kg/kg
DEA Schedule:
Schedule IV (CIV) Substances
Sample Package:
N/A
Marketing Category:
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date:
03-13-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Unfinished Product:
Yes
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 57218-954-01?

The NDC Packaged Code 57218-954-01 is assigned to an UNFINISHED drug package of 25 kg in 1 drum of Butorphanol Tartrate, a bulk ingredient labeled by Malladi Drugs And Pharmaceuticals Limited. The product's dosage form is powder and is administered via form.

Is NDC 57218-954 included in the NDC Directory?

Yes, Butorphanol Tartrate is an UNFINISHED PRODUCT with code 57218-954 that is active and included in the NDC Directory. The product was first marketed by Malladi Drugs And Pharmaceuticals Limited on March 13, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 57218-954-01?

The 11-digit format is 57218095401. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-257218-954-015-4-257218-0954-01