NDC Package 64950-359-04 Goprelto

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

Package Information
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:

64950-359-04

Package Description:

1 BOTTLE, GLASS in 1 CARTON / 4 mL in 1 BOTTLE, GLASS

Product Code:

64950-359

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:

64950035904

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

RxCUI: 1995288 - cocaine hydrochloride 4 % Nasal Solution

RxCUI: 1995288 - cocaine hydrochloride 40 MG/ML Nasal Solution

RxCUI: 1995293 - GOPRELTO 4 % Nasal Solution

RxCUI: 1995293 - cocaine hydrochloride 40 MG/ML Nasal Solution [Goprelto]

RxCUI: 1995293 - Goprelto 4 % Nasal Solution

Product Type:

Human Prescription Drug

Labeler Name:

Genus Lifesciences 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:

FDA Application Number:

NDA209963

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

01-08-2018

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

64950 - Genus Lifesciences Inc.
- 64950-359 - Goprelto
  - 64950-359-04 - 1 BOTTLE, GLASS in 1 CARTON / 4 mL in 1 BOTTLE, GLASS

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 64950-359-04?

The NDC Packaged Code 64950-359-04 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 Genus Lifesciences Inc.. The product's dosage form is solution and is administered via nasal form.

Is NDC 64950-359 included in the NDC Directory?

Yes, Goprelto with product code 64950-359 is active and included in the NDC Directory. The product was first marketed by Genus Lifesciences Inc. on January 08, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 64950-359-04?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 64950-359-04?

The 11-digit format is 64950035904. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	64950-359-04	5-4-2	64950-0359-04

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