Medicine
Lidocaine 50 mg/5 mL injection
Lidocaine 50 mg/5 mL injection is a generic prescription medicine for infiltration use, 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
NDC Container/Fill 0264-9376-88 5 mL ampoule 1% Lidocaine HCl Injection, USP…
Key facts
- Active ingredient (INN)
- Lidocaine
- Brand
- Sold under the generic name
- Strength
- 50 mg/5 mL
- Dosage form
- Injection
- Route
- Infiltration
- Packs
- 5 ampules of 5 mL
- Manufacturer
- B. Braun Medical
- Origin register
- US FDA, United States
- Storage
- NDC Container/Fill 0264-9376-88 5 mL ampoule 1% Lidocaine HCl Injection, USP solution 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
- 3 August 2018
- Identifiers
- RxCUI 1737566DailyMed set ID e0e479e6-4c94-44d0-8074-d0ee7b2bde22NDC 0264-9376Application ANDA208474
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 |
|---|---|---|---|
| 5 ampule in 1 carton / 5 mL in 1 ampule | 0264-9376-88 | B. Braun Medical | 3 August 2018 |
| 10 vial in 1 box / 5 mL in 1 vial | 71351-021-10 | — | 31 October 2022 |
| 25 vial in 1 box / 5 mL in 1 vial | 71351-021-25 | — | 31 October 2022 |
| 10 carton in 1 container / 1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic | 0409-9137-05 | — | 6 July 2005 |
| 10 vial in 1 box / 5 mL in 1 vial | 73293-0001-2 | — | 7 May 2020 |
| 10 vial, single-dose in 1 box / 5 mL in 1 vial, single-dose | 84769-0001-2 | — | 31 March 2025 |
| 1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic | 51662-1461-1 | — | 15 December 2019 |
| 1 carton in 1 bag / 1 syringe in 1 carton / 5 mL in 1 syringe | 0404-9889-05 | — | 12 January 2022 |
| 1 carton in 1 bag / 1 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic | 71872-7160-1 | — | 18 November 2019 |
| 5 mL in 1 syringe, plastic | 84549-137-05 | — | 19 September 2025 |
| 25 vial in 1 box / 5 mL in 1 vial | 63739-170-27 | — | 16 September 2022 |
| 25 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 0143-9595-25 | — | 16 June 1975 |
| 25 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 72572-370-25 | — | 16 June 1975 |
| 5 mL in 1 vial, single-dose | 51662-1438-1 | — | 21 December 2019 |
| 25 pouch in 1 case / 1 vial, single-dose in 1 pouch / 5 mL in 1 vial, single-dose | 51662-1438-3 | — | 9 January 2023 |
| 10 ampule in 1 carton / 5 mL in 1 ampule | 55150-159-74 | — | 14 March 2013 |
| 10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 55150-162-05 | — | 14 March 2013 |
| 10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 55150-162-09 | — | 14 March 2013 |
| 25 vial in 1 carton / 5 mL in 1 vial | 83854-011-26 | — | 2 October 2025 |
| 25 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 31722-117-32 | — | 8 November 2021 |
| 10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 31722-117-35 | — | 9 April 2024 |
| 10 vial in 1 carton / 5 mL in 1 vial | 70756-641-10 | — | 16 June 2023 |
| 25 vial in 1 carton / 5 mL in 1 vial | 70756-641-25 | — | 16 June 2023 |
| 1 vial in 1 carton / 5 mL in 1 vial | 70756-641-85 | — | 16 June 2023 |
| 5 cello pack in 1 package / 5 ampule in 1 cello pack / 5 mL in 1 ampule | 0409-4713-02 | — | 16 November 2005 |
| 5 cello pack in 1 carton / 5 ampule in 1 cello pack / 5 mL in 1 ampule | 0409-4713-30 | — | 19 October 2026 |
| 800 ampule in 1 case / 5 mL in 1 ampule | 0409-4713-65 | — | 8 July 2005 |
| 25 vial in 1 carton / 5 mL in 1 vial | 0781-3537-35 | — | 12 October 2026 |
| 25 ampule in 1 carton / 5 mL in 1 ampule | 65282-1605-1 | — | 18 April 2018 |
| 25 ampule in 1 carton / 5 mL in 1 ampule | 85766-187-25 | — | 20 March 2026 |
| 10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 85766-211-05 | — | 25 May 2026 |
| 10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 85766-211-10 | — | 7 October 2026 |
| 5 mL in 1 vial, single-dose | 76420-080-05 | — | 9 April 2020 |
| 25 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 83634-653-05 | — | 31 December 2025 |
| 5 mL in 1 vial, single-dose | 51662-1651-1 | — | 14 March 2013 |
| 1 ampule in 1 bag / 5 mL in 1 ampule | 71872-7190-1 | — | 7 January 2020 |
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 50 mg/5 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 Lidocaine 50 mg/5 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.