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  5. NDC Package Code: 80425-0350-1 Dyural 80-lm

NDC Package 80425-0350-1 Dyural 80-lm

Methylprednisolone Acetate,Lidocaine Hydrochloride,Bupivacaine Hydrochloride,Povidine - 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:
80425-0350-1
Package Description:
1 KIT in 1 CARTON * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1574-1) / 1 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) * 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05) / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code:
80425-0350
Proprietary Name:
Dyural 80-lm
Non-Proprietary Name:
Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol
Usage Information:
Bupivacaine Hydrochloride Injection is indicated in adults 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. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2)].
11-Digit NDC Billing Format:
80425035001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 1725078 - BUPivacaine HCl 0.25 % in 10 ML Injection
  • RxCUI: 1725078 - 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection
  • RxCUI: 1725078 - bupivacaine HCl 0.25 % in 10 ML Injection
  • RxCUI: 1725082 - BUPivacaine HCl 0.25 % in 30 ML Injection
  • RxCUI: 1725082 - 30 ML bupivacaine hydrochloride 2.5 MG/ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Advanced Rx Pharmacy Of Tennessee, Llc
    Dosage Form:
    Kit - A packaged collection of related material.
    Administration Route(s):
  • Epidural - Administration upon or over the dura mater.
  • Infiltration - Administration that results in substances passing into tissue spaces or into cells.
  • Intra-articular - Administration within a joint.
  • Intralesional - Administration within or introduced directly into a localized lesion.
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Soft Tissue - Administration into any soft tissue.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Sample Package:
    No
    Marketing Category:
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date:
    07-31-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:
    • 80425 - Advanced Rx Pharmacy Of Tennessee, Llc
      • 80425-0350 - Dyural 80-lm
        • 80425-0350-1 - 1 KIT in 1 CARTON * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1574-1) / 1 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) * 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05) / 5 mL in 1 VIAL, SINGLE-DOSE

    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 80425-0350-1?

    The NDC Packaged Code 80425-0350-1 is assigned to a package of 1 kit in 1 carton * .9 ml in 1 packet (67777-419-02) * 5 ml in 1 pouch * 1 vial, single-dose in 1 carton (70121-1574-1) / 1 ml in 1 vial, single-dose * 10 ml in 1 vial, single-dose (0409-1159-18) * 10 vial, single-dose in 1 carton (55150-162-05) / 5 ml in 1 vial, single-dose of Dyural 80-lm, a human prescription drug labeled by Advanced Rx Pharmacy Of Tennessee, Llc. The product's dosage form is kit and is administered via epidural; infiltration; intra-articular; intralesional; intramuscular; intravenous; soft tissue; subcutaneous; topical form.

    Is NDC 80425-0350 included in the NDC Directory?

    Yes, Dyural 80-lm with product code 80425-0350 is active and included in the NDC Directory. The product was first marketed by Advanced Rx Pharmacy Of Tennessee, Llc on July 31, 2023 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 80425-0350-1?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 80425-0350-1?

    The 11-digit format is 80425035001. 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
    5-4-180425-0350-15-4-280425-0350-01