Dyural 40 Kit
NDC Package 80425-0348-1

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

Package Information

Dyural 40 Kit (methylprednisolone acetate, lidocaine hydrochloride, bupivacaine hydrochloride, povidine iodine, sodium chloride, isopropyl alcohol) kits is 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. This formulation utilizes a kit delivery system. Marketed by Advanced Rx Pharmacy Of Tennessee, Llc, this product is identified by NDC 80425-0348.

Identification & Billing

NDC Package Code
80425-0348-1
Package Description
1 KIT in 1 CARTON * .9 mL in 1 PACKET (67777-419-02) * 10 mL in 1 VIAL, PLASTIC (0409-4887-17) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-4888-02) * 5 mL in 1 POUCH * 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 * 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1573-5) / 1 mL in 1 VIAL, SINGLE-DOSE
Product Code
80425-0348
11-Digit Billing Format
80425034801
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dyural 40 Kit
Non-Proprietary Name
Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Sodium Chloride, Isopropyl Alcohol
Dosage Form
Kit - A packaged collection of related material.
Administration Route
  • 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.
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)].

Regulatory & Marketing

Labeler Name
Advanced Rx Pharmacy Of Tennessee, Llc
Product Type
Human Prescription Drug
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
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage
  • 80425 - Advanced Rx Pharmacy Of Tennessee, Llc
    • 80425-0348 - Dyural 40 Kit
      • 80425-0348-1 - 1 KIT in 1 CARTON * .9 mL in 1 PACKET (67777-419-02) * 10 mL in 1 VIAL, PLASTIC (0409-4887-17) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-4888-02) * 5 mL in 1 POUCH * 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 * 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1573-5) / 1 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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 80425-0348-1 identifies a specific commercial package of 1 kit in 1 carton * .9 ml in 1 packet (67777-419-02) * 10 ml in 1 vial, plastic (0409-4887-17) * 10 ml in 1 vial, single-dose (0409-4888-02) * 5 ml in 1 pouch * 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 * 25 vial, single-dose in 1 carton (70121-1573-5) / 1 ml in 1 vial, single-dose of Dyural 40 Kit, a human prescription drug labeled by Advanced Rx Pharmacy Of Tennessee, Llc. This kit is formulated for epidural; infiltration; intra-articular; intralesional; intramuscular; intravenous; soft tissue; subcutaneous; topical use and contains 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 Advanced Rx Pharmacy Of Tennessee, Llc on July 31, 2023. The current certification is valid through December 31, 2026.

How is this Advanced Rx Pharmacy Of Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80425034801. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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 (5-4-1)
80425-0348-1
11-Digit CMS (5-4-2)
80425-0348-01

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