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Medicine

Desvenlafaxine 25 mg extended-release tablet

Available on requestPrescription onlyUS FDAGeneric name

Desvenlafaxine 25 mg extended-release tablet is a generic prescription medicine for oral use, made by 10 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 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…

Key facts

Active ingredient (INN)
Desvenlafaxine
Brand
Sold under the generic name
Strength
25 mg
Dosage form
Extended-release tablet
Route
Oral
Packs
100 tablets, 30 tablets, 80 tablets and 44 more
Manufacturers
Alembic PharmaceuticalsIndiaLupinIndiaBryant Ranch PrepackBreckenridge PharmaceuticalAdvagen PharmaActavis PharmaHikma PharmaceuticalsSlate Run Pharmaceuticals10 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted to 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
N06AX23 Desvenlafaxine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 March 2017
Identifiers
RxCUI 1607617, 1874553, 1874559DailyMed set ID b14695b4-c35e-4902-8144-d31d698b1c58, 5bd203d2-477e-4d12-a875-cb8009f42410, 7ee04e8c-ce6c-450d-9122-2bffd170bfd7 +14NDC 50090-7190, 46708-542, 50090-7468 +14Application ANDA204028, ANDA204003, ANDA204172 +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

A sample of 40 packs from 10 labelers. The register lists 47 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet, extended release in 1 carton46708-542-10Alembic PharmaceuticalsIndia14 September 2018
30 tablet, extended release in 1 bottle46708-542-30Alembic PharmaceuticalsIndia14 September 2018
100 tablet, extended release in 1 bottle46708-542-31Alembic PharmaceuticalsIndia14 September 2018
80 tablet, extended release in 1 carton46708-542-80Alembic PharmaceuticalsIndia14 September 2018
90 tablet, extended release in 1 bottle46708-542-90Alembic PharmaceuticalsIndia14 September 2018
1000 tablet, extended release in 1 bottle46708-542-91Alembic PharmaceuticalsIndia14 September 2018
30 tablet, film coated, extended release in 1 bottle68180-604-06LupinIndia25 August 2022
30 tablet, extended release in 1 bottle0591-4060-30Actavis Pharma1 March 2017
1000 tablet, extended release in 1 package72888-175-00Advagen Pharma14 March 2023
500 tablet, extended release in 1 package72888-175-05Advagen Pharma14 March 2023
30 tablet, extended release in 1 package72888-175-30Advagen Pharma14 March 2023
90 tablet, extended release in 1 package72888-175-90Advagen Pharma14 March 2023
100 tablet, extended release in 1 bottle51991-006-01Breckenridge Pharmaceutical28 November 2018
1000 tablet, extended release in 1 bottle51991-006-10Breckenridge Pharmaceutical28 November 2018
100 tablet, extended release in 1 carton51991-006-11Breckenridge Pharmaceutical28 November 2018
30 tablet, extended release in 1 bottle51991-006-33Breckenridge Pharmaceutical28 November 2018
80 tablet, extended release in 1 carton51991-006-80Breckenridge Pharmaceutical28 November 2018
90 tablet, extended release in 1 bottle51991-006-90Breckenridge Pharmaceutical28 November 2018
30 tablet, film coated, extended release in 1 bottle0054-0603-13Hikma Pharmaceuticals29 August 2017
30 tablet, extended release in 1 bottle, plastic70436-036-04Slate Run Pharmaceuticals5 January 2021
30 tablet, film coated, extended release in 1 bottle63629-7524-1Bryant Ranch Prepack24 January 2025
60 tablet, film coated, extended release in 1 bottle63629-7524-2Bryant Ranch Prepack24 January 2025
90 tablet, film coated, extended release in 1 bottle63629-7524-3Bryant Ranch Prepack24 January 2025
120 tablet, film coated, extended release in 1 bottle63629-7524-4Bryant Ranch Prepack24 January 2025
30 tablet, extended release in 1 bottle, plastic71335-1975-1Bryant Ranch Prepack14 October 2021
60 tablet, extended release in 1 bottle, plastic71335-1975-2Bryant Ranch Prepack18 July 2024
90 tablet, extended release in 1 bottle, plastic71335-1975-3Bryant Ranch Prepack18 July 2024
120 tablet, extended release in 1 bottle, plastic71335-1975-4Bryant Ranch Prepack14 October 2021
30 tablet, extended release in 1 bottle71335-2130-1Bryant Ranch Prepack13 March 2023
60 tablet, extended release in 1 bottle71335-2130-2Bryant Ranch Prepack13 March 2023
90 tablet, extended release in 1 bottle71335-2130-3Bryant Ranch Prepack1 November 2024
120 tablet, extended release in 1 bottle71335-2130-4Bryant Ranch Prepack1 November 2024
30 tablet, extended release in 1 bottle71335-2490-1Bryant Ranch Prepack18 September 2024
60 tablet, extended release in 1 bottle71335-2490-2Bryant Ranch Prepack18 September 2024
90 tablet, extended release in 1 bottle71335-2490-3Bryant Ranch Prepack18 September 2024
120 tablet, extended release in 1 bottle71335-2490-4Bryant Ranch Prepack18 September 2024
30 tablet, film coated, extended release in 1 bottle71335-2494-1Bryant Ranch Prepack16 September 2024
60 tablet, film coated, extended release in 1 bottle71335-2494-2Bryant Ranch Prepack16 September 2024
90 tablet, film coated, extended release in 1 bottle71335-2494-3Bryant Ranch Prepack16 September 2024
120 tablet, film coated, extended release in 1 bottle71335-2494-4Bryant Ranch Prepack16 September 2024

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 29 February 2008Drugs@FDA
EU (EMA)Application withdrawnEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenWithdrawnEuropean 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 Desvenlafaxine 25 mg extended-release tablet.

Compare 1

Other strengths and forms of Desvenlafaxine

Clinical summary

Desvenlafaxine is a serotonin and norepinephrine reuptake inhibitor indicated for the treatment of adults with major depressive disorder (MDD). It is available as extended-release tablets for oral use. MedsAcross supplies Desvenlafaxine 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 Desvenlafaxine

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

Data sources

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