Prescription drug · ANDA
Lidocaine Hydrochloride NDC 0904-7644
Lidocaine hydrochloride 20 mg/mL · Solution · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7644-87 | 00904764487 | 4 TRAY in 1 CASE (0904-7644-87) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0904-7644-88)Marketed from Aug 21, 2026 |
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 — 20 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218138
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0904-7644_30c013e7-4df8-4692-8b8e-ba1466d15681SPL ID 30c013e7-4df8-4692-8b8e-ba1466d15681SPL set ID 04e8dd94-93a8-427d-81ab-a95793d86c36RxCUI 1010739UNII V13007Z41AUPC 0309047644889
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400904764487followed by a unit qualifier and the quantityPackage 00904-7644-87. 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)
INDICATIONS AND USAGE: Lidocaine Hydrochloride Oral Topical Solution, USP 2% (Viscous) is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.
Excerpt only. Read the full label for complete information.
About NDC 0904-7644
- What is NDC 0904-7644?
- 0904-7644 is the product NDC for Lidocaine Hydrochloride, Lidocaine hydrochloride 20 mg/mL solution, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lidocaine Hydrochloride.
- What is the active ingredient?
- Lidocaine hydrochloride.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lidocaine Hydrochloride?
- 189 other product NDCs are listed under this name. See all Lidocaine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lidocaine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lidocaine Hydrochloride | Lidocaine 5 g/100g | CreamTopical | YYBA CORP | 73581-120 | 73581-0120-0173581-0120-0273581-0120-06 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride anhydrous 10 mg/mL | Injection, SolutionInfiltration, Perineural | Henry Schein, Inc. | 0404-9763 | 00404-9763-20 |
| lidocaine hydrochloride | Lidocaine hydrochloride 10 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Avenacy, LLC | 83634-653 | 83634-0653-0283634-0653-0583634-0653-30 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionIntravenous | Brookfield Pharmaceuticals, LLC. | 71351-027 | 71351-0027-25 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 10 mg/mL | SolutionIntravenous | Brookfield Pharmaceuticals, LLC. | 71351-026 | 71351-0026-25 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 10 mg/mL | Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-940 | 23155-0940-41 |
| Lidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral, Topical | American Health Packaging | 60687-870 | 60687-0870-64 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral, Topical | Aurobindo Pharma Limited | 59651-943 | 59651-0943-01 |
| lidocaine hydrochloride | Lidocaine hydrochloride 10 mg/mL | Injection, SolutionInfiltration, Perineural | Medical Purchasing Solutions, LLC | 71872-7362 | 71872-7362-01 |
| lidocaine hydrochloride | Lidocaine hydrochloride 10 mg/mL | Injection, SolutionInfiltration, Perineural | Avenacy, LLC | 83634-651 | 83634-0651-1083634-0651-2083634-0651-50 |
Other NDCs under ANDA 218138
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 20 mg/mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0950 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral | PAI Holdings, LLC dba PAI Pharma | 0121-4950 |
| Lidocaine Hydrochloride | Lidocaine hydrochloride 20 mg/mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8847 |