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  5. NDC Package Code: 53225-4000-1 Readysharp Anesthetics Plus Ketorolac

NDC Package 53225-4000-1 Readysharp Anesthetics Plus Ketorolac

View Billable Units, 11-Digit Format, RxNorm

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 inactivated by the FDA.

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:
53225-4000-1
Package Description:
1 KIT in 1 KIT * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1560-10) * 1 mL in 1 VIAL, SINGLE-DOSE (0409-3793-19) * 2 mL in 1 AMPULE (0409-4713-42)
Product Code:
53225-4000
Proprietary Name:
Readysharp Anesthetics Plus Ketorolac
Usage Information:
Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. MARCAINE is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS.) Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of MARCAINE in these patients.MARCAINE is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS. The routes of administration and indicated MARCAINE concentrations are:∙ local infiltration                                                                                 0.25%∙ peripheral nerve block                                                                      0.25% and 0.5%∙ retrobulbar block                                                                              0.75%∙ sympathetic block                                                                             0.25%∙ lumbar epidural                                                                                 0.25%, 0.5%, and 0.75%                                                                                                          (0.75% not for obstetrical anesthesia)∙ caudal                                                                                               0.25% and 0.5%∙ epidural test dose                                                                              0.5% with epinephrine 1:200,000∙ dental blocks                                                                                     0.5% with epinephrine 1:200,000(See DOSAGE AND ADMINISTRATION for additional information.) Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of MARCAINE. Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Acute Pain in Adult PatientsKetorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.Ketorolac tromethamine injection has been used concomitantly with morphine and meperidine and has shown an opioid-sparing effect. For breakthrough pain, it is recommended to supplement the lower end of the ketorolac tromethamine injection dosage range with low doses of narcotics prn, unless otherwise contraindicated. Ketorolac tromethamine injection and narcotics should not be administered in the same syringe (see DOSAGE AND ADMINISTRATION – Pharmaceutical Information for Ketorolac Tromethamine Injection).
11-Digit NDC Billing Format:
53225400001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1724880 - BUPivacaine HCl 0.5 % in 10 ML Injection
  • RxCUI: 1724880 - 10 ML bupivacaine hydrochloride 5 MG/ML Injection
  • RxCUI: 1724880 - bupivacaine HCl 0.5 % in 10 ML Injection
  • RxCUI: 1724884 - BUPivacaine HCl 0.5 % in 30 ML Injection
  • RxCUI: 1724884 - 30 ML bupivacaine hydrochloride 5 MG/ML Injection
    • Labeler Name:
    Terrain Pharmaceuticals
    Sample Package:
    No
    Start Marketing Date:
    12-29-2015
    Listing Expiration Date:
    12-31-2018
    Exclude Flag:
    I
    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 53225-4000-1?

    The NDC Packaged Code 53225-4000-1 is assigned to a package of 1 kit in 1 kit * 10 ml in 1 vial, single-dose (0409-1560-10) * 1 ml in 1 vial, single-dose (0409-3793-19) * 2 ml in 1 ampule (0409-4713-42) of Readysharp Anesthetics Plus Ketorolac, labeled by Terrain Pharmaceuticals. The product's dosage form is and is administered via form.

    Is NDC 53225-4000 included in the NDC Directory?

    No, Readysharp Anesthetics Plus Ketorolac with product code 53225-4000 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Terrain Pharmaceuticals on December 29, 2015 and its listing in the NDC Directory is set to expire on December 31, 2018 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 53225-4000-1?

    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 53225-4000-1?

    The 11-digit format is 53225400001. 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 5-4-1 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
    5-4-153225-4000-15-4-253225-4000-01