Ketamine Hydrochloride Injection, Solution, Concentrate
NDC Package 0404-9882-10

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

Package Information

Ketamine Hydrochloride injection is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. This formulation utilizes a injection, solution, concentrate delivery system. 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
RxNorm Crosswalk
  • RxCUI: 238084 - ketamine 50 MG/ML Injectable Solution
  • RxCUI: 238084 - ketamine (as ketamine hydrochloride) 50 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Ketamine Hydrochloride
Non-Proprietary Name
Ketamine Hydrochloride
Substance Name
Ketamine Hydrochloride
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
KETAMINE HYDROCHLORIDE 50 mg/mL
Pharmacologic Class
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.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Henry Schein, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA074549
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-11-2022
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 0404-9882-10 identifies a specific commercial package of 1 vial in 1 bag / 10 ml in 1 vial of Ketamine Hydrochloride, a human prescription drug labeled by Henry Schein, Inc.. This injection, solution, concentrate is formulated for intramuscular; intravenous use and contains ketamine 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 Henry Schein, Inc. on January 11, 2022. The current certification is valid through December 31, 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.