Ketalar Injection
NDC Package 42023-113-10

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

Package Information

Ketalar (ketamine hydrochloride) injection is kETALAR is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. This formulation utilizes a injection delivery system. Marketed by Par Health Usa, Llc, this product is identified by NDC 42023-113 and is authorized under FDA application NDA016812.

Identification & Billing

NDC Package Code
42023-113-10
Package Description
10 VIAL in 1 CARTON / 20 mL in 1 VIAL
Product Code
42023-113
11-Digit Billing Format
42023011310
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ketalar
Non-Proprietary Name
Ketamine Hydrochloride
Substance Name
Ketamine Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
KETAMINE HYDROCHLORIDE 10 mg/mL
Pharmacologic Class
Usage Information
KETALAR is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. KETALAR is best suited for short procedures but it can be used, with additional doses, for longer procedures. KETALAR is indicated for the induction of anesthesia prior to the administration of other general anesthetic agents. KETALAR 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
Par Health Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA016812
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-01-2007
Listing Expiration
12-31-2027
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 42023-113-10 identifies a specific commercial package of 10 vial in 1 carton / 20 ml in 1 vial of Ketalar, a human prescription drug labeled by Par Health Usa, Llc. This injection 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 Par Health Usa, Llc on October 01, 2007. The current certification is valid through December 31, 2027.

How is this Par Health Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42023011310. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-3-2)
42023-113-10
11-Digit CMS (5-4-2)
42023-0113-10

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