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  5. NDC Package Code: 53225-3125-4 Readysharp-a

NDC Package 53225-3125-4 Readysharp-a

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
53225-3125-4
Package Description:
1 KIT in 1 CARTON * 2 mL in 1 AMPULE (0409-4713-42) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1560-10)
Product Code:
53225-3125
Proprietary Name:
Readysharp-a
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.
11-Digit NDC Billing Format:
53225312504
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
    FDA Application Number:
    NDA016964
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    53225-3125-11 KIT in 1 KIT * 2 mL in 1 AMPULE (0409-4713-42) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1560-10)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53225-3125-4?

    The NDC Packaged Code 53225-3125-4 is assigned to a package of 1 kit in 1 carton * 2 ml in 1 ampule (0409-4713-42) * 10 ml in 1 vial, single-dose (0409-1560-10) of Readysharp-a, labeled by Terrain Pharmaceuticals. The product's dosage form is and is administered via form.

    Is NDC 53225-3125 included in the NDC Directory?

    No, Readysharp-a with product code 53225-3125 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 11-digit format for NDC 53225-3125-4?

    The 11-digit format is 53225312504. 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
    5-4-153225-3125-45-4-253225-3125-04