Cocaine Hydrochloride Nasal Solution
NDC Package 81665-301-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cocaine Hydrochloride Nasal solution is 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 Omnivium Pharmaceuticals Llc., this product is identified by NDC 81665-301 and is authorized under FDA application NDA209575.

Identification & Billing

NDC Package Code
81665-301-02
Package Description
1 BOTTLE, GLASS in 1 CARTON / 4 mL in 1 BOTTLE, GLASS
Product Code
81665-301
11-Digit Billing Format
81665030102
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cocaine Hydrochloride Nasal
Non-Proprietary Name
Cocaine Hydrochloride Nasal
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
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
COCAINE HYDROCHLORIDE 40 mg/mL
Usage Information
Cocaine Hydrochloride nasal solution is 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
Omnivium Pharmaceuticals Llc.
Product Type
Human Prescription Drug
FDA Application #
NDA209575
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
10-15-2023
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 81665-301-02 identifies a specific commercial package of 1 bottle, glass in 1 carton / 4 ml in 1 bottle, glass of Cocaine Hydrochloride Nasal, a human prescription drug labeled by Omnivium Pharmaceuticals Llc.. This solution is formulated for topical 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 Omnivium Pharmaceuticals Llc. on October 15, 2023. The current certification is valid through December 31, 2026.

How is this Omnivium Pharmaceuticals Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81665030102. 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)
81665-301-02
11-Digit CMS (5-4-2)
81665-0301-02

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