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  5. NDC Package Code: 0409-2053-10 Ketamine Hydrochloride

NDC Package 0409-2053-10 Ketamine Hydrochloride

Injection, Solution, Concentrate Intramuscular; Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
0409-2053-10
Package Description:
10 VIAL, MULTI-DOSE in 1 BOX / 10 mL in 1 VIAL, MULTI-DOSE (0409-2053-20)
Product Code:
0409-2053
Proprietary Name:
Ketamine Hydrochloride
Non-Proprietary Name:
Ketamine Hydrochloride
Substance Name:
Ketamine Hydrochloride
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.
11-Digit NDC Billing Format:
00409205310
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 238083 - ketamine 100 MG/ML Injectable Solution
  • RxCUI: 238083 - ketamine (as ketamine hydrochloride) 100 MG/ML Injectable Solution
  • RxCUI: 238084 - ketamine 50 MG/ML Injectable Solution
  • RxCUI: 238084 - ketamine (as ketamine hydrochloride) 50 MG/ML Injectable Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hospira, Inc.
    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(s):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • KETAMINE HYDROCHLORIDE 50 mg/mL
    • Pharmacologic Class(es):
  • General Anesthesia - [PE] (Physiologic Effect)
  • General Anesthetic - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA074549
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-30-2004
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 0409-2053-10?

    The NDC Packaged Code 0409-2053-10 is assigned to a package of 10 vial, multi-dose in 1 box / 10 ml in 1 vial, multi-dose (0409-2053-20) of Ketamine Hydrochloride, a human prescription drug labeled by Hospira, Inc.. The product's dosage form is injection, solution, concentrate and is administered via intramuscular; intravenous form.

    Is NDC 0409-2053 included in the NDC Directory?

    Yes, Ketamine Hydrochloride with product code 0409-2053 is active and included in the NDC Directory. The product was first marketed by Hospira, Inc. on November 30, 2004 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 0409-2053-10?

    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 0409-2053-10?

    The 11-digit format is 00409205310. 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 4-4-2 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20409-2053-105-4-200409-2053-10