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Medicine

Efavirenz 600 mg tablet

Efavirenz · Oral
Available on requestPrescription onlyUS FDAGeneric name

Efavirenz 600 mg tablet is a generic prescription medicine for oral use, made by 5 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

Efavirenz tablets, USP should be stored at 25°C (77°F), excursions permitted…

Key facts

Active ingredient (INN)
Efavirenz
Brand
Sold under the generic name
Strength
600 mg
Dosage form
Tablet
Route
Oral
Packs
3 blister pack, 30 tablets, 250 tablets and 5 more
Manufacturers
Aurobindo PharmaIndiaCamber PharmaceuticalsIndiaCiplaIndiaMacleods PharmaceuticalsIndiaXLCare Pharmaceuticals
Origin register
US FDA, United States
Storage
Efavirenz tablets, USP should be stored at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
J05AG03 Efavirenz
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
27 April 2018
Identifiers
RxCUI 349477DailyMed set ID 966b815d-1d78-4b54-8f00-c5a0b67c78be, 13ca3456-e5bf-4bb1-af95-b1378658a358, c5eedb5d-4cab-4056-a14a-ffdf67701355 +2NDC 72865-172, 33342-013, 65862-049 +2Application ANDA078886, ANDA091579, ANDA077673 +1

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
3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack65862-049-10Aurobindo PharmaIndia21 September 2018
30 tablet, film coated in 1 bottle65862-049-30Aurobindo PharmaIndia21 September 2018
250 tablet, film coated in 1 bottle31722-504-25Camber PharmaceuticalsIndia27 April 2018
30 tablet, film coated in 1 bottle31722-504-30Camber PharmaceuticalsIndia27 April 2018
30 tablet, film coated in 1 bottle69097-301-02CiplaIndia18 June 2018
30 tablet in 1 bottle33342-013-07Macleods PharmaceuticalsIndia10 May 2024
250 tablet, film coated in 1 bottle72865-172-25XLCare Pharmaceuticals29 May 2021
30 tablet, film coated in 1 bottle72865-172-30XLCare Pharmaceuticals29 May 2021

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 17 September 1998Drugs@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 Efavirenz

Clinical summary

Efavirenz is a human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults, among other approved uses. MedsAcross supplies Efavirenz 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 Efavirenz

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

Data sources

Need Efavirenz 600 mg tablet 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.