Levetiracetam Injection
NDC Package 0264-1009-90

11-digit billing NDC: 00264100990 · Billing unit: ML · 2400 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Levetiracetam injection is aseptic technique is required.Caution: Before use, perform the following checks: Read the label. This formulation utilizes a injection delivery system. Marketed by B. Braun Medical Inc., this product is identified by NDC 0264-1009 and is authorized under FDA application ANDA209705.

Identification & Billing

NDC Package Code
0264-1009-90
Package Description
24 CONTAINER in 1 CASE / 100 mL in 1 CONTAINER
Product Code
0264-1009
11-Digit Billing Format
00264100990
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
2400 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Levetiracetam
Non-Proprietary Name
Levetiracetam
Substance Name
Levetiracetam
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
LEVETIRACETAM 10 mg/mL
Pharmacologic Class
Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
Usage Information
Aseptic technique is required.Caution: Before use, perform the following checks: Read the label. Ensure solution is the one ordered and is within the expiration date.Inspect the solution in good light for cloudiness, haze or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used.Use only if solution is clear and container and seals are intact. Single-dose plastic container. Discard unused portion. Consult Package Insert for complete product information.The physician should also be alert to the possibility of adverse reactions to drug additives diluted and administered from the plastic partial fill container. Prescribing information for drug additives to be administered in this manner should be consulted.WARNING: DO NOT USE PLASTIC CONTAINER IN SERIES CONNECTION.This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.1. Identify Two Ports (See Figure A).2. To Add MedicationRemove additive port closure: hold container below additive port and grasp cap between thumb and forefinger then flip cap upward (See Figure B). Swab exposed additive port. Using a syringe with 18 gauge or smaller needle, insert cannula through resealable additive port and add desire drug. Mix thoroughly.Note: Partial fill containers have been designed to accept an overfill of up to 50 mL.3. To Attach Administration SetTo aseptically remove the set port closure: hold container below the set port and grasp the foil tab between the thumb and forefinger then pull the tab in two steps as shown in Figure C Steps 1 and 2.4. Push spike through the diaphragm of the port (See Figure D). Hang container using hole on the lower flap. Prime set in accordance with the Directions for Use provided with the set in use.When the container is to be used as a diluent and delivery system for intermittent intravenous administration of compatible drug additives, consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.Warning: Some additives may be incompatible. Consult with Pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.PAB® containers can be safely transported in a standard 6-inch carrier through a pneumatic tube system that is well maintained and running properly.

Regulatory & Marketing

Labeler Name
B. Braun Medical Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA209705
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-13-2024
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1958
Source: ASP
Inj levetirac sodi chlo 5 mg
HCPCS Dosage 5 MG
Units / Pkg 4800

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 0264-1009-90 identifies a specific commercial package of 24 container in 1 case / 100 ml in 1 container of Levetiracetam, a human prescription drug labeled by B. Braun Medical Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 2400 billable units per package. This injection is formulated for intravenous use and contains levetiracetam 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 B. Braun Medical Inc. on May 13, 2024. The current certification is valid through December 31, 2026.

How is this B. Braun Medical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00264100990. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 2400 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)
0264-1009-90
11-Digit CMS (5-4-2)
00264-1009-90

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