Lorazepam Powder
NDC Package 48087-0076-0

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.

Lorazepam powders is a medication used to treat serious seizures that do not stop (status epilepticus). This formulation utilizes a powder delivery system. Marketed by F.i.s. Fabbrica Italiana Sintetici S.p.a., this product is identified by NDC 48087-0076.

Identification & Billing

NDC Package Code
48087-0076-0
Package Description
50 kg in 1 DRUM
Product Code
48087-0076
11-Digit Billing Format
48087007600

Clinical Specifications

Proprietary Name
Lorazepam
Non-Proprietary Name
Lorazepam
Substance Name
Lorazepam
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)
LORAZEPAM 1 kg/kg
Usage Information
This medication is used to treat serious seizures that do not stop (status epilepticus). It is also used before surgeries or procedures to cause drowsiness, decrease anxiety, and cause forgetfulness about the procedure or surgery. Lorazepam belongs to a class of medications called benzodiazepines, which produce a calming effect on the brain and nerves (central nervous system). It is thought to work by increasing the effect of a certain natural chemical (GABA) in the brain.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
F.i.s. Fabbrica Italiana Sintetici S.p.a.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-09-2010
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 48087-0076-0 identifies a specific commercial package of 50 kg in 1 drum of Lorazepam (UNFINISHED drug), a bulk ingredient labeled by F.i.s. Fabbrica Italiana Sintetici S.p.a.. This powder is formulated for use and contains lorazepam 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 F.i.s. Fabbrica Italiana Sintetici S.p.a. on April 09, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat serious seizures that do not stop (status epilepticus). It is also used before surgeries or procedures to cause drowsiness, decrease anxiety, and cause forgetfulness about the procedure or surgery. Lorazepam belongs to a class of medications called benzodiazepines, which produce a calming effect on the brain and nerves (central nervous system). It is thought to work by increasing the effect of a certain natural chemical (GABA) in the brain.

How is this F.i.s. Fabbrica Italiana Sintetici S.p.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48087007600. 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)
48087-0076-0
11-Digit CMS (5-4-2)
48087-0076-00

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