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Medicine

Lidocaine and Prilocaine 25 mg/25 mg per g cream

Available on requestPrescription onlyUS FDAGeneric name

Lidocaine and Prilocaine 25 mg/25 mg per g cream is a generic prescription medicine for topical use, made by 11 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Key facts

Active ingredient (INN)
Lidocaine and Prilocaine
Brand
Sold under the generic name
Strength
25 mg/25 mg per g
Dosage form
Cream
Route
Topical
Packs
1 tube, 5 tubes, 30 g and 20 more
Manufacturers
Alembic PharmaceuticalsIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaBryant Ranch PrepackE. FougeraA-S Medication SolutionsPreferred PharmaceuticalsEncube EthicalsNuCare PharamceuticalsNuCare Pharmaceuticals,Inc
Origin register
US FDA, United States
Storage
Store at controlled room temperature 15° to 30°C (59° to 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
N01BB20 Lidocaine and Prilocaine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
18 August 2003
Identifiers
RxCUI 197877DailyMed set ID 5900691d-8b50-7752-e053-2991aa0a5c5c, 3cd9a055-8b9b-4dff-967b-54023df72e43, a65a29ca-9476-4290-9384-67df4caec655 +14NDC 68071-1625, 72162-1125, 21922-076 +14Application ANDA076290, ANDA212482, ANDA076320 +3

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.

PackCodeLabelerMarketed since
1 tube in 1 carton / 5 g in 1 tube46708-582-04Alembic PharmaceuticalsIndia3 April 2025
1 tube in 1 carton / 30 g in 1 tube46708-582-31Alembic PharmaceuticalsIndia3 April 2025
1 tube in 1 carton / 5 g in 1 tube62332-582-04Alembic PharmaceuticalsIndia11 August 2022
1 tube in 1 carton / 30 g in 1 tube62332-582-31Alembic PharmaceuticalsIndia12 April 2022
1 tube in 1 carton / 30 g in 1 tube72578-165-06Viona PharmaceuticalsIndia1 January 2025
5 tube in 1 carton / 5 g in 1 tube72578-165-96Viona PharmaceuticalsIndia1 January 2025
1 tube in 1 carton / 30 g in 1 tube70771-1872-2Zydus LifesciencesIndia1 January 2025
5 tube in 1 carton / 5 g in 1 tube70771-1872-8Zydus LifesciencesIndia1 January 2025
1 tube in 1 carton / 30 g in 1 tube0168-0357-30E. Fougera18 August 2003
1 tube in 1 carton / 5 g in 1 tube0168-0357-55E. Fougera21 July 2004
1 tube in 1 carton / 5 g in 1 tube0168-0357-56E. Fougera21 July 2004
1 tube in 1 carton / 30 g in 1 tube21922-076-05Encube Ethicals12 December 2024
1 tube in 1 carton / 30 g in 1 tube0574-2042-30Padagis20 December 2022
1 tube in 1 carton / 30 g in 1 tube63629-9604-1Bryant Ranch Prepack19 December 2022
1 tube in 1 carton / 30 g in 1 tube71335-2716-1Bryant Ranch Prepack28 July 2025
1 tube in 1 carton / 30 g in 1 tube71335-2970-1Bryant Ranch Prepack21 October 2025
1 tube in 1 carton / 30 g in 1 tube72162-1125-3Bryant Ranch Prepack11 January 2024
1 tube in 1 carton / 30 g in 1 tube50090-6589-0A-S Medication Solutions11 August 2023
1 tube in 1 carton / 30 g in 1 tube50090-8089-0A-S Medication Solutions23 September 2026
1 tube in 1 carton / 30 g in 1 tube68788-4090-3Preferred Pharmaceuticals17 March 2026
1 tube in 1 carton / 30 g in 1 tube68788-8150-3Preferred Pharmaceuticals4 March 2022
30 g in 1 box68071-1625-3NuCare Pharamceuticals,Inc12 September 2017
1 tube in 1 carton / 30 g in 1 tube68071-3856-3NuCare Pharmaceuticals30 May 2025

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 30 December 1992Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS 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 and Prilocaine

Clinical summary

Lidocaine and Prilocaine is a fixed-dose combination of an amide local anesthetic and an antiarrhythmic indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing. MedsAcross supplies Lidocaine and Prilocaine 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 Lidocaine and Prilocaine

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Lidocaine and Prilocaine 25 mg/25 mg per g cream 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.