Medicine
Xylocaine 34 mcg/34 mg per 1.7 mL injection
Xylocaine 34 mcg/34 mg per 1.7 mL injection is a prescription medicine containing Epinephrine and Lidocaine for submucosal use, marketed by Dentsply Pharmaceutical, 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
Do not permit to freeze. Store at controlled room temperature, below 25°C…
Key facts
- Active ingredient (INN)
- Epinephrine and Lidocaine
- Brand
- Xylocaine
- Strength
- 34 mcg/34 mg per 1.7 mL
- Dosage form
- Injection
- Route
- Submucosal
- Packs
- 50 cartridges of 1.7 mL
- Marketing authorisation holder
- Dentsply Pharmaceutical
- Manufacturer
- Dentsply Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Do not permit to freeze. Store at controlled room temperature, below 25°C (77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 January 1985
- Identifiers
- RxCUI 1010768, 1293648, 1608499 +1DailyMed set ID 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1NDC 66312-181Application ANDA088389
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 |
|---|---|---|---|
| 50 cartridge in 1 carton / 1.7 mL in 1 cartridge | 66312-181-16 | Dentsply Pharmaceutical | 14 April 2009 |
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 Epinephrine and Lidocaine
Clinical summary
Epinephrine and Lidocaine is a fixed-dose combination of an amide local anesthetic, an antiarrhythmic and a catecholamine. It is available as injection for infiltration, perineural and submucosal use. MedsAcross supplies Epinephrine and 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 Epinephrine and 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 34 mcg/34 mg per 1.7 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.