Naloxone Hydrochloride
NDC Package 63629-9321-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Naloxone Hydrochloride is naloxone HCl Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.Naloxone HCl Nasal Spray is not a substitute for emergency medical care.Limitations of Use:Restrict prescription of naloxone hydrochloride nasal spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts. Marketed by Bryant Ranch Prepack, this product is identified by NDC 63629-9321 and is authorized under FDA application ANDA211951.

Identification & Billing

NDC Package Code
63629-9321-1
Package Description
2 VIAL, SINGLE-DOSE in 1 CARTON / .1 mL in 1 VIAL, SINGLE-DOSE
Product Code
63629-9321
11-Digit Billing Format
63629932101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Naloxone Hydrochloride
Dosage Form
-
Usage Information
Naloxone HCl Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.Naloxone HCl Nasal Spray is not a substitute for emergency medical care.Limitations of Use:Restrict prescription of naloxone hydrochloride nasal spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
FDA Application #
ANDA211951
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-21-2022
End Marketing Date
09-30-2025
Listing Expiration
09-30-2025
Exclude Flag
D
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 63629-9321-1 identifies a specific commercial package of 2 vial, single-dose in 1 carton / .1 ml in 1 vial, single-dose of Naloxone Hydrochloride, labeled by Bryant Ranch Prepack. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Bryant Ranch Prepack on June 21, 2022. The current certification is valid through September 30, 2025.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63629932101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-4-1)
63629-9321-1
11-Digit CMS (5-4-2)
63629-9321-01

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