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Medicine

Tenofovir disoproxil 300 mg tablet

Available on requestPrescription onlyUS FDAGeneric name

Tenofovir disoproxil 300 mg tablet is a generic prescription medicine for oral use, made by 15 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 tenofovir disoproxil fumarate tablets at 25°C (77°F), excursions…

Key facts

Active ingredient (INN)
Tenofovir disoproxil
Brand
Sold under the generic name
Strength
300 mg
Dosage form
Tablet
Route
Oral
Packs
30 tablets, 100 tablets, 500 tablets and 22 more
Manufacturers
Camber PharmaceuticalsIndiaCiplaIndiaAurobindo PharmaIndiaMacleods PharmaceuticalsIndiaStrides PharmaIndiaBryant Ranch PrepackA-S Medication SolutionsAvKAREAvPAKChartwell RX
Origin register
US FDA, United States
Storage
Store tenofovir disoproxil fumarate tablets at 25°C (77°F), excursions permitted to 15-30°C(59-86°F). • Keep container tightly closed. • Dispense only in original container. • Do not use if seal over bottle opening is broken or missing.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
J05AF07 Tenofovir disoproxil
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
26 January 2018
Identifiers
RxCUI 349251, 1243227, 1243324 +1DailyMed set ID 67e0e1b7-6a45-4d63-b569-00826832c25a, 0c7d72d6-bf80-49e0-921c-20169e87e62f, 1ac4c628-f01f-42d4-b8e6-d12273aefc6d +15NDC 50090-7202, 71921-105, 31722-535 +15Application ANDA090636, ANDA209498, ANDA203232 +4

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
30 tablet, film coated in 1 bottle65862-421-30Aurobindo PharmaIndia26 January 2018
100 tablet, film coated in 1 bottle31722-535-01Camber PharmaceuticalsIndia26 January 2018
500 tablet, film coated in 1 bottle31722-535-05Camber PharmaceuticalsIndia26 January 2018
1000 tablet, film coated in 1 bottle31722-535-10Camber PharmaceuticalsIndia26 January 2018
30 tablet, film coated in 1 bottle31722-535-30Camber PharmaceuticalsIndia26 January 2018
60 tablet, film coated in 1 bottle31722-535-60Camber PharmaceuticalsIndia26 January 2018
30 tablet in 1 bottle69097-533-02CiplaIndia26 January 2018
1000 tablet in 1 bottle69097-533-15CiplaIndia26 January 2018
30 tablet, film coated in 1 bottle33342-096-07Macleods PharmaceuticalsIndia26 January 2018
30 tablet in 1 bottle64380-714-04Strides PharmaIndia26 January 2018
30 tablet, film coated in 1 bottle62135-466-30Chartwell RX30 June 2022
30 tablet, coated in 1 bottle, plastic71921-105-33Florida Pharmaceutical Products26 November 2025
30 tablet, coated in 1 bottle, plastic69076-105-03Quinn Pharmaceuticals1 January 2020
30 tablet, film coated in 1 bottle63629-9729-1Bryant Ranch Prepack11 August 2023
30 tablet, coated in 1 bottle, plastic71335-2364-1Bryant Ranch Prepack30 April 2024
15 tablet, coated in 1 bottle, plastic71335-2364-2Bryant Ranch Prepack30 April 2024
30 tablet, coated in 1 bottle, plastic71335-3155-1Bryant Ranch Prepack13 July 2026
15 tablet, coated in 1 bottle, plastic71335-3155-2Bryant Ranch Prepack13 July 2026
30 tablet, film coated in 1 bottle50090-7202-0A-S Medication Solutions1 August 2024
30 tablet, coated in 1 bottle, plastic50090-8173-0A-S Medication Solutions28 October 2026
30 tablet, film coated in 1 bottle42291-800-30AvKARE10 January 2019
20 blister pack in 1 box / 1 tablet in 1 blister pack50268-758-12AvPAK30 March 2020
30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack0904-6821-04Major Pharmaceuticals26 January 2018
30 tablet, film coated in 1 bottle16714-820-01NorthStar RxLLC12 November 2018
7 tablet, film coated in 1 bottle, plastic72789-361-07PD-Rx Pharmaceuticals26 October 2023

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 26 October 2001Drugs@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

Alternatives

Other makers and brands of Tenofovir disoproxil 300 mg tablet.

Compare 1

Other strengths and forms of Tenofovir disoproxil

Clinical summary

Tenofovir disoproxil is a hepatitis B virus nucleoside analog reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, among other approved uses. MedsAcross supplies Tenofovir disoproxil 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 Tenofovir disoproxil

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

Need Tenofovir disoproxil 300 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.