Prescription drug · ANDA
lidocaine hydrochloride NDC 83634-653
Lidocaine hydrochloride 10 mg/mL · Injection, Solution · Epidural, Infiltration, Intracaudal, Perineural · Avenacy, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83634-653-02 | 83634065302 | 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-653-02) / 2 mL in 1 VIAL, SINGLE-DOSE (83634-653-41)Marketed from Dec 31, 2025 | |
| 83634-653-05 | 83634065305 | 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-653-05) / 5 mL in 1 VIAL, SINGLE-DOSE (83634-653-42)Marketed from Dec 31, 2025 | |
| 83634-653-30 | 83634065330 | 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-653-30) / 30 mL in 1 VIAL, SINGLE-DOSE (83634-653-43)Marketed from Dec 31, 2025 |
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)
- lidocaine hydrochloride
- Generic name (nonproprietary)
- lidocaine hydrochloride
- Active ingredients
- Lidocaine hydrochloride — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural, Infiltration, Intracaudal, Perineural
- Labeler
- Avenacy, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219535
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 83634-653_8fb1dd7b-f349-4a64-96c1-bd72bf748f3bSPL ID 8fb1dd7b-f349-4a64-96c1-bd72bf748f3bSPL set ID 46480253-29b9-4d7f-98ed-10377929026bRxCUI 1010033, 1737562, 1737566, 1737568UNII V13007Z41A
- Pharmacologic class
- Amide Local Anesthetic; Antiarrhythmic
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.
- NDC on a medical claim
N483634065302followed by a unit qualifier and the quantityPackage 83634-0653-02. 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 .
Indications (excerpt from the label)
Lidocaine hydrochloride injection is indicated in adult and pediatric patients 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 lidocaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration ( 2.2 )] . Lidocaine hydrochloride injection contains lidocaine, an amide local anesthetic. Lidocaine hydrochloride injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or…
Excerpt only. Read the full label for complete information.