Prescription drug · UNAPPROVED DRUG OTHER
Dyural 80-LM NDC 76420-796
Kit · Epidural, Infiltration, Intra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue, Subcutaneous, Topical · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-796-01 | 76420079601 | 1 KIT in 1 CARTON (76420-796-01) * .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-DOSEMarketed from Jan 11, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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-LM
- Generic name (nonproprietary)
- methylprednisolone acetate, lidocaine hydrochloride, bupivacaine hydrochloride, povidine iodine, isopropyl alcohol
- Dosage form
- Kit
- Route
- Epidural, Infiltration, Intra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue, Subcutaneous, Topical
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 76420-796_23b53a4c-c516-cabc-e063-6394a90ab44eSPL ID 23b53a4c-c516-cabc-e063-6394a90ab44eSPL set ID c4071146-7d89-4c3a-9278-389d801cf66dRxCUI 797544, 797730, 1725078, 1725082, 1737566, 1743855
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.
- NDC on a medical claim
N476420079601followed by a unit qualifier and the quantityPackage 76420-0796-01. 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 . 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.