Prescription drug · ANDA
Lidocaine Hydrochloride NDC 0404-9798
Lidocaine hydrochloride anhydrous 10 mg/mL · Injection, Solution · Infiltration, Perineural · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9798-50 | 00404979850 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9798-50) / 50 mL in 1 VIAL, MULTI-DOSEMarketed from May 27, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 anhydrous — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Infiltration, Perineural
- Labeler
- Henry Schein, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214336
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0404-9798_8212757b-7c15-45a7-8a90-6b1a09d0d812SPL ID 8212757b-7c15-45a7-8a90-6b1a09d0d812SPL set ID fa7dedcd-d78b-45f2-9dd7-f273043167d0RxCUI 1010033UNII EC2CNF7XFP
- 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
N400404979850followed by a unit qualifier and the quantityPackage 00404-9798-50. 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 an…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214336
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Lidocaine hydrochloride | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | NorthStar RxLLC | 72603-722 |
| Lidocaine hydrochloride | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | NorthStar RxLLC | 72603-732 |
| Lidocaine hydrochloride | Lidocaine hydrochloride anhydrous 20 mg/mL | Injection, SolutionInfiltration, Perineural | NorthStar RxLLC | 72603-744 |
| Lidocaine hydrochloride | Lidocaine hydrochloride anhydrous 20 mg/mL | Injection, SolutionInfiltration, Perineural | Medical Purchasing Solutions, LLC | 71872-7377 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9763 |
| Lidocaine hydrochloride | Lidocaine hydrochloride anhydrous 20 mg/mL | Injection, SolutionInfiltration, Perineural | NorthStar RxLLC | 72603-825 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride anhydrous 20 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9797 |
| Lidocaine hydrochloride | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | Camber Pharmaceuticals, Inc. | 31722-116 |
| Lidocaine hydrochloride | Lidocaine hydrochloride anhydrous 20 mg/mL | Injection, SolutionInfiltration, Perineural | Camber Pharmaceuticals, Inc. | 31722-217 |