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Medicine

Duloxetine 20 mg delayed-release capsule

Duloxetine · Oral
Available on requestPrescription onlyUS FDAGeneric name

Duloxetine 20 mg delayed-release capsule is a generic prescription medicine for oral use, made by 33 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 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).

Key facts

Active ingredient (INN)
Duloxetine
Brand
Sold under the generic name
Strength
20 mg
Dosage form
Delayed-release capsule
Route
Oral
Packs
30 capsules, 60 capsules, 90 capsules and 144 more
Manufacturers
Alembic PharmaceuticalsIndiaCamber PharmaceuticalsIndiaAscend LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaAjanta PharmaIndiaMacleods PharmaceuticalsIndiaAurobindo PharmaIndiaLupinIndiaMarksans PharmaIndia33 labelers on the register
Origin register
US FDA, United States
Storage
Store at 25°C (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
N06AX21 Duloxetine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 May 2012
Identifiers
RxCUI 596926, 596930, 596934 +1DailyMed set ID f8c0bc80-b34e-daa8-e053-6394a90a05c2, 2dde979d-b6f8-41d1-96fb-325c75ea3a74, caef6f50-1571-4ec7-8f8c-42b924d323ee +37NDC 80425-0311, 27241-097, 51991-746 +37Application ANDA208706, ANDA203088, ANDA090694 +13

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 33 labelers. The register lists 147 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
30 capsule, delayed release in 1 bottle46708-278-30Alembic PharmaceuticalsIndia9 June 2014
60 capsule, delayed release in 1 bottle46708-278-60Alembic PharmaceuticalsIndia9 June 2014
90 capsule, delayed release in 1 bottle46708-278-90Alembic PharmaceuticalsIndia9 June 2014
1000 capsule, delayed release in 1 bottle46708-278-91Alembic PharmaceuticalsIndia9 April 2026
30 capsule, delayed release in 1 bottle62332-278-30Alembic PharmaceuticalsIndia9 April 2026
60 capsule, delayed release in 1 bottle62332-278-60Alembic PharmaceuticalsIndia9 April 2026
90 capsule, delayed release in 1 bottle62332-278-90Alembic PharmaceuticalsIndia9 April 2026
1000 capsule, delayed release in 1 bottle62332-278-91Alembic PharmaceuticalsIndia9 April 2026
500 capsule, delayed release in 1 bottle27241-097-05Ajanta PharmaIndia18 October 2021
60 capsule, delayed release in 1 bottle27241-097-06Ajanta PharmaIndia16 March 2017
1000 capsule, delayed release in 1 bottle27241-097-10Ajanta PharmaIndia16 March 2017
90 capsule, delayed release in 1 bottle27241-097-90Ajanta PharmaIndia18 October 2021
100 capsule, delayed release in 1 bottle67877-263-01Ascend LaboratoriesIndia1 May 2012
1000 capsule, delayed release in 1 bottle67877-263-10Ascend LaboratoriesIndia1 May 2012
30 capsule, delayed release in 1 bottle67877-263-30Ascend LaboratoriesIndia1 May 2012
60 capsule, delayed release in 1 bottle67877-263-60Ascend LaboratoriesIndia1 May 2012
90 capsule, delayed release in 1 bottle67877-263-90Ascend LaboratoriesIndia1 May 2012
60 capsule, delayed release in 1 bottle59651-279-60Aurobindo PharmaIndia11 December 2013
10 blister pack in 1 carton / 10 capsule, delayed release in 1 blister pack59651-279-78Aurobindo PharmaIndia11 December 2013
1000 capsule, delayed release in 1 bottle59651-279-99Aurobindo PharmaIndia11 December 2013
100 capsule, delayed release in 1 bottle31722-168-01Camber PharmaceuticalsIndia30 December 2020
500 capsule, delayed release in 1 bottle31722-168-05Camber PharmaceuticalsIndia29 June 2024
1000 capsule, delayed release in 1 bottle31722-168-10Camber PharmaceuticalsIndia30 December 2020
30 capsule, delayed release in 1 bottle31722-168-30Camber PharmaceuticalsIndia30 December 2020
7 capsule, delayed release in 1 blister pack31722-168-31Camber PharmaceuticalsIndia30 December 2020
105 capsule, delayed release in 1 carton31722-168-32Camber PharmaceuticalsIndia30 December 2020
60 capsule, delayed release in 1 bottle31722-168-60Camber PharmaceuticalsIndia30 December 2020
90 capsule, delayed release in 1 bottle31722-168-90Camber PharmaceuticalsIndia29 June 2024
1000 capsule, delayed release in 1 bottle68180-294-03LupinIndia11 December 2013
60 capsule, delayed release in 1 bottle68180-294-07LupinIndia11 December 2013
60 capsule, delayed release in 1 bottle33342-160-09Macleods PharmaceuticalsIndia24 March 2017
90 capsule, delayed release in 1 bottle33342-160-10Macleods PharmaceuticalsIndia24 March 2017
10 blister pack in 1 carton / 10 capsule, delayed release in 1 blister pack33342-160-12Macleods PharmaceuticalsIndia24 March 2017
1000 capsule, delayed release in 1 bottle33342-160-44Macleods PharmaceuticalsIndia24 March 2017
60 capsule, delayed release in 1 bottle25000-608-06Marksans PharmaIndia27 May 2022
100 capsule, delayed release in 1 bottle47335-381-08Sun Pharmaceutical IndustriesIndia11 December 2013
1000 capsule, delayed release in 1 bottle47335-381-18Sun Pharmaceutical IndustriesIndia11 December 2013
100 blister pack in 1 carton / 1 capsule, delayed release in 1 blister pack47335-381-61Sun Pharmaceutical IndustriesIndia11 December 2013
30 capsule, delayed release in 1 bottle47335-381-83Sun Pharmaceutical IndustriesIndia11 December 2013
60 capsule, delayed release in 1 bottle47335-381-86Sun Pharmaceutical IndustriesIndia11 December 2013

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 3 August 2004Drugs@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 Duloxetine 20 mg delayed-release capsule.

Compare 1

Other strengths and forms of Duloxetine

Clinical summary

Duloxetine is a serotonin and norepinephrine reuptake inhibitor indicated for the treatment of major Depressive Disorder in adults, among other approved uses. It is available as delayed-release capsules for oral use. MedsAcross supplies Duloxetine 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 Duloxetine

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

Data sources

Need Duloxetine 20 mg delayed-release capsule 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.