Medicine
Lidocaine 40 mg/mL topical solution
Lidocaine 40 mg/mL topical solution is a generic prescription medicine for topical use, made by 12 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
AVOID FREEZING Rx Only Product No.: 4025 Manufactured By: GROUPE PARIMA Inc…
Key facts
- Active ingredient (INN)
- Lidocaine
- Brand
- Sold under the generic name
- Strength
- 40 mg/mL
- Dosage form
- Topical solution
- Route
- Topical
- Packs
- 1 bottle, 50 mL, 25 vials and 10 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaBryant Ranch PrepackGolden State Medical SupplyHealthFirstHikma PharmaceuticalsInternational Medication SystemsMarlex PharmaceuticalsNovitium PharmaPAI PharmaSKY Packaging
- Origin register
- US FDA, United States
- Storage
- AVOID FREEZING Rx Only Product No.: 4025 Manufactured By: GROUPE PARIMA Inc. 4450 Cousens Montreal, Quebec, Canada H4S 1X6 Manufactured For: Xttrium Laboratories, Inc. 1200 E. Store at 20 ° to 25 °C (68 ° to 77 °F). Mount Prospect, IL 60056 4025LIDOINST REV. 03-25 RECOMMENDED STORAGE RECOMMENDED STORAGE Store at 20 ° to 25 °C (68 ° to 77 °F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01BB01 Lidocaine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 November 1982
- Identifiers
- RxCUI 1010878DailyMed set ID 31a5a48e-27d7-90f3-e063-6294a90a2d9e, 903cd7bd-6c3d-4068-bb24-e91b1ca1393d, 9920daef-b156-4a14-b641-f714191ffb5c +10NDC 0116-4025, 63739-997, 0121-0972 +10Application ANDA087881, ANDA204494, ANDA218411 +4
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 50 mL in 1 bottle | 51672-1411-3 | Sun Pharmaceutical IndustriesIndia | 8 December 2023 |
| 50 mL in 1 bottle | 0054-3505-47 | Hikma Pharmaceuticals | 3 April 1985 |
| 25 vial in 1 carton / 4 mL in 1 vial | 76329-6300-5 | International Medication Systems | 19 June 2012 |
| 1 bottle in 1 carton / 50 mL in 1 bottle | 83148-043-50 | The J. Molner | 1 November 2024 |
| 1 bottle in 1 carton / 50 mL in 1 bottle | 70954-518-10 | Novitium Pharma | 23 March 2022 |
| 1 bottle, glass in 1 carton / 50 mL in 1 bottle, glass | 0121-0972-51 | PAI Pharma | 31 July 2023 |
| 1 bottle, glass in 1 carton / 50 mL in 1 bottle, glass | 0116-4025-50 | Xttrium Laboratories | 31 March 2025 |
| 1 bottle, glass in 1 carton / 50 mL in 1 bottle, glass | 72162-2620-2 | Bryant Ranch Prepack | 20 April 2026 |
| 1 bottle in 1 carton / 50 mL in 1 bottle | 72162-2627-2 | Bryant Ranch Prepack | 23 April 2026 |
| 50 mL in 1 bottle | 51407-825-50 | Golden State Medical Supply | 8 August 2023 |
| 25 pouch in 1 case / 1 vial in 1 pouch / 4 mL in 1 vial | 51662-1553-3 | HealthFirst | 14 June 2021 |
| 1 bottle in 1 carton / 50 mL in 1 bottle | 10135-736-51 | Marlex Pharmaceuticals | 1 June 2022 |
| 1 bottle in 1 carton / 50 mL in 1 bottle | 63739-997-64 | SKY Packaging | 27 June 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 19 November 1948 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Lidocaine
Clinical summary
Lidocaine is an amide local anesthetic. It is available as injection, ointment and patches for infiltration, perineural and topical use. MedsAcross supplies Lidocaine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about LidocaineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Xylocaine prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Lidocaine 40 mg/mL topical solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.