Over-the-counter drug · OTC MONOGRAPH DRUG
Lidocaine NDC 58980-823
Lidocaine 50 mg/g · Cream · Topical · STRATUS PHARMACEUTICALS INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58980-823-05 | 58980082305 | 1 TUBE in 1 BOX (58980-823-05) / 14.17 g in 1 TUBEMarketed from Dec 18, 2023 | |
| 58980-823-30 | 58980082330 | 1 TUBE in 1 BOX (58980-823-30) / 28.35 g in 1 TUBEMarketed from Aug 12, 2019 |
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
- Generic name (nonproprietary)
- lidocaine
- Active ingredients
- Lidocaine — 50 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- STRATUS PHARMACEUTICALS INCNDC labeler code 58980
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 58980-823_4b196450-e9de-4c85-8652-42d926d951d5SPL ID 4b196450-e9de-4c85-8652-42d926d951d5SPL set ID 87a4f559-a4f6-4b9f-98de-b55b073a11c6RxCUI 1534792UNII 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
N458980082305followed by a unit qualifier and the quantityPackage 58980-0823-05. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 58980-823
- What is NDC 58980-823?
- 58980-823 is the product NDC for Lidocaine, Lidocaine 50 mg/g cream, listed with the FDA by STRATUS PHARMACEUTICALS INC. It has 2 package NDCs, 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?
- STRATUS PHARMACEUTICALS INC, NDC labeler code 58980. 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 | Direct_Rx | 72189-692 | 72189-0692-50 |
| 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 |
Other NDCs under M 017
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 |
|---|---|---|---|---|
| 0.5% Lidocaine Burn Relieflidocaine hydrochloride | Lidocaine hydrochloride .5 g/100g | GelTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-099 |
| 0.5% Lidocaine Burn Relieflidocaine hydrochloride | Lidocaine hydrochloride .5 g/100g | GelTopical | Universal Distribution Center LLC | 52000-437 |
| 1% Hydrocortisone Anti-itch | Hydrocortisone 10 mg/g | CreamTopical | ALAINA HEALTHCARE PRIVATE LIMITED | 73492-291 |
| 10% Methyl Salicylate Pain Relief Patch10% methyl salicylate | Methyl salicylate 10 mg/100mg | TapeTopical | Akron Coating & Adhesives | 65604-222 |
| 11681168 burn spray | Lidocaine hydrochloride .02 mg/mL | SprayTopical | Dynarex Corporation | 67777-013 |
| 2.0% Lidocaine Burnlidocaine hydrochloride | Lidocaine hydrochloride 2 g/100mL | SprayTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-097 |
| 2.0% Lidocaine Burnlidocaine hydrochloride | Lidocaine hydrochloride 2 g/100mL | SprayTopical | Universal Distribution Center LLC | 52000-441 |
| 2.5% Menthol PAIN RELIEFmenthol | Menthol, Unspecified form 25 mg/g | GelTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-096 |
| 2.5% Menthol PAIN RELIEFmenthol | Menthol, Unspecified form 25 mg/g | GelTopical | Universal Distribution Center LLC | 52000-440 |
| 24 7 Relief and Recovery Pain Relievingmenthol, unspecified form | Menthol, Unspecified form 37 mg/mL | CreamTopical | Triplicare Inc | 87656-964 |
| 2677 First Aid Burn Cream | Benzalkonium chloride 13 mg/10000mg; Lidocaine hydrochloride 50 mg/10000mg | CreamTopical | ProStat First Aid LLC | 58228-2677 |
| 2nd CHANCE MOBILITY Pain Reliefhistamine dihydrochloride | Histamine dihydrochloride .5 mg/g | CreamTopical | ALPHA NUTRITION, LLC | 83984-441 |
| 365 Medicated Lip Balmmedicated lip balm | Camphor (Natural) .0578 g/4.25g | StickTopical | Whole Foods Market, Inc. | 42681-0001 |
| 3X Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | Rite Aid | 11822-0613 |
| 4 Lidocaine Topical Anestheticlidocaine | Lidocaine 40 mg/g | CreamTopical | RUGBY LABORATORIES | 0536-1267 |
| 4% Lidocaine Maximum Strength Pain Relieflidocaine | Lidocaine .04 g/1 | PatchTopical | Shenzhen Finona Information Technology Co., Ltd | 85839-011 |
| 4% Lidocaine Pain Relief Patchlidocaine 4% | Lidocaine .04 g/1 | PatchTransdermal | Guangxi Keyun E-commerce Co., Ltd. | 87278-003 |
| 4% Lidocaine Pain Relief Patchlidocaine 4% | Lidocaine .04 g/1 | PatchTransdermal | Guangxi Keyun E-commerce Co., Ltd. | 87278-020 |
| 4% Lidocaine Patches4% lidocaine | Lidocaine 40 mg/1 | PatchTopical | Shenzhen Huayuan Hengsheng Technology Co., Ltd. | 87394-002 |
| 4% Lidocaine Patches | Lidocaine 4 g/1001 | PatchTopical | Shenzhen Chaoxiji Technology Co.,Ltd. | 87794-006 |
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