Prescription drug · ANDA
lidocaine NDC 80425-0554
Lidocaine 50 mg/g · Ointment · Topical · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0554-1 | 80425055401 | 50 g in 1 JAR (80425-0554-1)Marketed from Oct 15, 2025 |
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)
- lidocaine
- Generic name (nonproprietary)
- lidocaine
- Active ingredients
- Lidocaine — 50 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206498
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 80425-0554_4134f315-4fcf-c3b5-e063-6394a90ac253SPL ID 4134f315-4fcf-c3b5-e063-6394a90ac253SPL set ID 4134f30d-5cb0-e14b-e063-6394a90a4523RxCUI 1543069UNII 98PI200987
- 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480425055401followed by a unit qualifier and the quantityPackage 80425-0554-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Lidocaine ointment, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.
Excerpt only. Read the full label for complete information.
About NDC 80425-0554
- What is NDC 80425-0554?
- 80425-0554 is the product NDC for lidocaine, Lidocaine 50 mg/g ointment, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- lidocaine.
- What is the active ingredient?
- Lidocaine.
- Who is the labeler?
- Advanced Rx 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 lidocaine?
- 157 other product NDCs are listed under this name. See all lidocaine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other lidocaine 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 | Lidocaine 50 mg/g | OintmentTopical | Preferred Pharmaceuticals Inc. | 68788-4195 | 68788-4195-05 |
| Lidocaine | Lidocaine 50 mg/g | PatchTopical | Ascend Laboratories, LLC | 67877-767 | 67877-0767-30 |
| Lidocaine | Lidocaine 80 mg/mL | SprayTopical | YYBA CORP | 73581-900 | 73581-0900-01 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Advanced Rx of Tennessee, LLC | 80425-0594 | 80425-0594-01 |
| Lidocainelidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | JellyTopical | Sentiss Pharmaceuticals LLC | 70244-039 | 70244-0039-0170244-0039-02 |
| Lidocaine | Lidocaine 100 kg/100kg | GranuleTopical | Shaanxi Shuvita Biotech Co., Ltd | 87879-002 | 87879-0002-02 |
| Lidocainelidicaine | Lidocaine 50 mg/g | OintmentTopical | Encube Ethicals, Inc. | 21922-107 | 21922-0107-1321922-0107-61 |
| Lidocaine | Lidocaine hydrochloride 50 mg/mL | GelTopical | YYBA Corp | 73581-115 | 73581-0115-03 |
| Lidocaine | Lidocaine 5 g/100mL | CreamTopical | YYBA Corp | 73581-022 | 73581-0022-06 |
| Lidocainelidocaine, menthol | Menthol .1 g/10g; Lidocaine .4 g/10g | PatchTransdermal | Vive Health LLC | 84722-3072 | 84722-3072-00 |
Other NDCs under ANDA 206498
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 | Lidocaine 50 mg/g | OintmentTopical | Northstar Rx LLC | 16714-878 |
| lidocaine | Lidocaine 50 mg/g | OintmentTopical | REMEDYREPACK INC. | 70518-3902 |
| lidocaine | Lidocaine 50 mg/g | OintmentTopical | REMEDYREPACK INC. | 70518-3972 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Direct_Rx | 72189-499 |
| lidocaine | Lidocaine 50 mg/g | OintmentTopical | Proficient Rx LP | 71205-717 |
| lidocaine | Lidocaine 50 mg/g | OintmentTopical | Asclemed USA, Inc. | 76420-125 |
| lidocaine | Lidocaine 50 mg/g | OintmentTopical | Proficient Rx LP | 71205-500 |
| lidocaine | Lidocaine 50 mg/g | OintmentTopical | Advanced Rx of Tennessee, LLC | 80425-0450 |
| lidocaine | Lidocaine 50 mg/g | OintmentTopical | Preferred Pharmaceuticals Inc. | 68788-8396 |
| lidocaine | Lidocaine 50 mg/g | OintmentTopical | Glenmark Pharmaceuticals Inc., USA | 68462-418 |
| lidocaine | Lidocaine 50 mg/g | OintmentTopical | Asclemed USA, Inc. | 76420-550 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0248 |
| lidocaine | Lidocaine 50 mg/g | OintmentTopical | A-S Medication Solutions | 50090-7922 |
| lidocaine | Lidocaine 50 mg/g | OintmentTopical | PHOENIX RX LLC | 85509-1418 |