Cocaine Hydrochloride Solution
NDC Package 70839-362-04

11-digit billing NDC: 70839036204 · Billing unit: ML · 4 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Cocaine Hydrochloride solution is cOCAINE HYDROCHLORIDE nasal solution is an ester local anesthetic indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults. This formulation utilizes a solution delivery system. Marketed by Lxo Us Inc., this product is identified by NDC 70839-362 and is authorized under FDA application NDA209963.

Identification & Billing

NDC Package Code
70839-362-04
Package Description
1 BOTTLE, GLASS in 1 CARTON / 4 mL in 1 BOTTLE, GLASS
Product Code
70839-362
11-Digit Billing Format
70839036204
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
4 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cocaine Hydrochloride
Non-Proprietary Name
Cocaine Hydrochloride
Substance Name
Cocaine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
COCAINE HYDROCHLORIDE 40 mg/mL
Usage Information
COCAINE HYDROCHLORIDE nasal solution is an ester local anesthetic indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Lxo Us Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA209963
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
01-29-2024
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.

J0014
Source: ASP
Cocaine hcl nasal (goprelto)
HCPCS Dosage 1 MG
Units / Pkg 160

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 70839-362-04 identifies a specific commercial package of 1 bottle, glass in 1 carton / 4 ml in 1 bottle, glass of Cocaine Hydrochloride, a human prescription drug labeled by Lxo Us Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 4 billable units per package. This solution is formulated for nasal use and contains cocaine hydrochloride 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 Lxo Us Inc. on January 29, 2024. The current certification is valid through December 31, 2026.

How is this Lxo Us Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70839036204. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 4 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 (5-3-2)
70839-362-04
11-Digit CMS (5-4-2)
70839-0362-04

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