What is NDC 80425-0349?

80425-0349 is the product NDC for Dyural 80 Kit kit, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Dyural 80 Kit (Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Sodium Chloride, Isopropyl Alcohol).

Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dyural 80 Kit?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dyural 80 Kit NDC 80425-0349 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0349Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0349Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
80425-0349-1	8042503490180425034901	1 KIT in 1 CARTON (80425-0349-1) * 10 mL in 1 VIAL, PLASTIC (0409-4887-17) * 1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1574-1) / 1 mL in 1 VIAL, SINGLE-DOSE * 5 mL in 1 POUCH * 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05) / 5 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL, SINGLE-DOSE (0409-4888-02) * .9 mL in 1 PACKET (67777-419-02) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18)Marketed from Jul 31, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Dyural 80 Kit
Generic name (nonproprietary): methylprednisolone acetate, lidocaine hydrochloride, bupivacaine hydrochloride, povidine iodine, sodium chloride, isopropyl alcohol
Dosage form: Kit
Route: Epidural, Infiltration, Intra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue, Subcutaneous, Topical
Labeler: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Jul 31, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 80425-0349_2a9c2eb6-a6dd-f647-e063-6294a90a93feSPL ID 2a9c2eb6-a6dd-f647-e063-6294a90a93feSPL set ID 01ca2f07-9c84-e418-e063-6294a90ac760RxCUI 797544, 797730, 1725078, 1725082, 1737566, 1743855, 1807631, 1807637, 1807638

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N480425034901 followed by a unit qualifier and the quantity

Package 80425-0349-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Dec 31, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

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) ]. Bupivacaine Hydrochloride Injection contains bupivacaine, an amide local anesthetic. Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and or…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0349

What is NDC 80425-0349?: 80425-0349 is the product NDC for Dyural 80 Kit kit, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dyural 80 Kit (Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Sodium Chloride, Isopropyl Alcohol).
Who is the labeler?: Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dyural 80 Kit?: 1 other product NDC are listed under this name. See all Dyural 80 Kit NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Dyural 80 Kit NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dyural 80 Kitmethylprednisolone acetate, lidocaine hydrochloride, bupivacaine hydrochloride, povidine iodine, sodium chloride, isopropyl alcohol	—	KitEpidural, Infiltration, Intra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue, Subcutaneous, Topical	Asclemed USA, Inc.	76420-755	76420-0755-01