Ketamine Hydrochloride
NDC Package 0404-9882-10

11-digit billing NDC: 00404988210
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.

Ketamine Hydrochloride is injection is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Marketed by Henry Schein, Inc., this product is identified by NDC 0404-9882 and is authorized under FDA application ANDA074549.

Identification & Billing

NDC Package Code
0404-9882-10
Package Description
1 VIAL in 1 BAG / 10 mL in 1 VIAL
Product Code
0404-9882
11-Digit Billing Format
00404988210

Clinical Specifications

Proprietary Name
Ketamine Hydrochloride
Dosage Form
-
Usage Information
Ketamine hydrochloride injection is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine hydrochloride injection is best suited for short procedures but it can be used, with additional doses, for longer procedures.Ketamine hydrochloride injection is indicated for the induction of anesthesia prior to the administration of other general anesthetic agents.Ketamine hydrochloride injection is indicated to supplement low-potency agents, such as nitrous oxide.Specific areas of application are described in the CLINICAL PHARMACOLOGY Section.

Regulatory & Marketing

Labeler Name
Henry Schein, Inc.
FDA Application #
ANDA074549
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-11-2022
End Marketing Date
10-05-2026
Listing Expiration
10-05-2026
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 0404-9882-10 identifies a specific commercial package of 1 vial in 1 bag / 10 ml in 1 vial of Ketamine Hydrochloride, labeled by Henry Schein, Inc.. 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 Henry Schein, Inc. on January 11, 2022. The current certification is valid through October 05, 2026.

How is this Henry Schein, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00404988210. 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 (4-4-2)
0404-9882-10
11-Digit CMS (5-4-2)
00404-9882-10

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