Medicine
Xylocaine 400 mg/20 mL injection
Xylocaine 400 mg/20 mL injection is a prescription medicine containing Lidocaine for infiltration, perineural use, marketed by Fresenius Kabi, 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
All solutions should be stored at 20° to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Lidocaine
- Brand
- Xylocaine
- Strength
- 400 mg/20 mL
- Dosage form
- Injection
- Route
- Infiltration, perineural
- Packs
- 25 vials of 20 mL, 1 vial of 20 mL
- Marketing authorisation holder
- Fresenius Kabi
- Manufacturers
- Fresenius KabiHenry Schein
- Origin register
- US FDA, United States
- Storage
- All solutions should be stored at 20° to 25°C (68° to 77°F). Protect from light.
- 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
- 12 August 2010
- Identifiers
- RxCUI 1010671, 1010673, 1010033 +7DailyMed set ID a6019956-a6e0-4988-a870-6aee06c354c3, ba082c2f-64f4-419d-9c88-74f203316e17, 4dd52202-8eef-4136-92dd-ada573b7cf74NDC 0404-9974, 63323-486Application NDA006488
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 25 vial, multi-dose in 1 tray / 20 mL in 1 vial, multi-dose | 63323-486-26 | Fresenius Kabi | 12 August 2010 |
| 25 vial, multi-dose in 1 tray / 20 mL in 1 vial, multi-dose | 63323-486-27 | Fresenius Kabi | 12 August 2010 |
| 1 vial in 1 bag / 20 mL in 1 vial | 0404-9974-20 | Henry Schein | 17 January 2022 |
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
Alternatives
Other makers and brands of Lidocaine 400 mg/20 mL injection.
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 Xylocaine 400 mg/20 mL injection 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.