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  5. NDC Package Code: 70839-359-04 Goprelto

NDC Package 70839-359-04 Goprelto

Cocaine Hydrochloride Solution Nasal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
70839-359-04
Package Description:
1 BOTTLE, GLASS in 1 CARTON / 4 mL in 1 BOTTLE, GLASS
Product Code:
70839-359
Proprietary Name:
Goprelto
Non-Proprietary Name:
Cocaine Hydrochloride
Substance Name:
Cocaine Hydrochloride
Usage Information:
GOPRELTO (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.
11-Digit NDC Billing Format:
70839035904
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Lxo Us Inc.
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(s):
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s):
COCAINE HYDROCHLORIDE 40 mg/mL
DEA Schedule:
Schedule II (CII) Substances
Sample Package:
No
FDA Application Number:
NDA209963
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
02-09-2024
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
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 70839-359-04?

The NDC Packaged Code 70839-359-04 is assigned to a package of 1 bottle, glass in 1 carton / 4 ml in 1 bottle, glass of Goprelto, a human prescription drug labeled by Lxo Us Inc.. The product's dosage form is solution and is administered via nasal form.

Is NDC 70839-359 included in the NDC Directory?

Yes, Goprelto with product code 70839-359 is active and included in the NDC Directory. The product was first marketed by Lxo Us Inc. on February 09, 2024 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 70839-359-04?

The 11-digit format is 70839035904. 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
5-3-270839-359-045-4-270839-0359-04