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Medicine

Esomeprazole 20 mg delayed-release capsule

Esomeprazole · Oral
Available on requestPrescription onlyUS FDAGeneric name

Esomeprazole 20 mg delayed-release capsule is a generic prescription medicine for oral use, made by 32 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)
Esomeprazole
Brand
Sold under the generic name
Strength
20 mg
Dosage form
Delayed-release capsule
Route
Oral
Packs
100 capsules, 1 blister pack, 30 capsules and 146 more
Manufacturers
Aurobindo PharmaIndiaZydus LifesciencesIndiaAscend LaboratoriesIndiaBioconIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaGranules IndiaIndiaSun Pharmaceutical IndustriesIndiaMacleods PharmaceuticalsIndiaLannett32 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
A02BC05 Esomeprazole
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
3 August 2015
Identifiers
RxCUI 606726, 606730DailyMed set ID 2f1b1a56-b6c4-4e30-a1f7-12701aa5a535, 2690dbe7-e559-4de8-9582-79b627af1964, f3d4a0d7-77fd-496e-8dfa-2b2dbace4bac +37NDC 71335-9713, 76420-904, 67877-478 +37Application ANDA213486, ANDA211977, ANDA208333 +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 32 labelers. The register lists 149 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 capsule, delayed release in 1 bottle59651-561-01Aurobindo PharmaIndia20 November 2023
1 blister pack in 1 carton / 14 capsule, delayed release in 1 blister pack59651-561-14Aurobindo PharmaIndia20 November 2023
30 capsule, delayed release in 1 bottle59651-561-30Aurobindo PharmaIndia20 November 2023
90 capsule, delayed release in 1 bottle59651-561-90Aurobindo PharmaIndia20 November 2023
1000 capsule, delayed release in 1 bottle59651-561-99Aurobindo PharmaIndia20 November 2023
100 capsule, delayed release in 1 bottle65862-783-01Aurobindo PharmaIndia21 April 2016
30 capsule, delayed release in 1 bottle65862-783-30Aurobindo PharmaIndia21 April 2016
10 blister pack in 1 carton / 10 capsule, delayed release in 1 blister pack65862-783-78Aurobindo PharmaIndia21 April 2016
90 capsule, delayed release in 1 bottle65862-783-90Aurobindo PharmaIndia21 April 2016
1000 capsule, delayed release in 1 bottle65862-783-99Aurobindo PharmaIndia21 April 2016
30 capsule, delayed release in 1 bottle68382-441-06Zydus LifesciencesIndia30 May 2019
1000 capsule, delayed release in 1 bottle68382-441-10Zydus LifesciencesIndia30 May 2019
90 capsule, delayed release in 1 bottle68382-441-16Zydus LifesciencesIndia30 May 2019
1000 capsule, delayed release in 1 bottle70771-1493-0Zydus LifesciencesIndia30 May 2019
30 capsule, delayed release in 1 bottle70771-1493-3Zydus LifesciencesIndia30 May 2019
90 capsule, delayed release in 1 bottle70771-1493-9Zydus LifesciencesIndia30 May 2019
500 capsule, delayed release in 1 bottle67877-478-05Ascend LaboratoriesIndia20 October 2017
1000 capsule, delayed release in 1 bottle67877-478-10Ascend LaboratoriesIndia20 October 2017
30 capsule, delayed release in 1 bottle67877-478-30Ascend LaboratoriesIndia20 October 2017
10 blister pack in 1 carton / 10 capsule, delayed release in 1 blister pack67877-478-38Ascend LaboratoriesIndia20 October 2017
90 capsule, delayed release in 1 bottle67877-478-90Ascend LaboratoriesIndia20 October 2017
30 capsule, delayed release in 1 bottle70377-055-11BioconIndia19 March 2021
90 capsule, delayed release in 1 bottle70377-055-12BioconIndia19 March 2021
1000 capsule, delayed release in 1 bottle70377-055-13BioconIndia19 March 2021
1000 capsule, delayed release in 1 bottle31722-664-10Camber PharmaceuticalsIndia2 June 2020
30 capsule, delayed release in 1 bottle31722-664-30Camber PharmaceuticalsIndia2 June 2020
90 capsule, delayed release in 1 bottle31722-664-90Camber PharmaceuticalsIndia2 June 2020
1000 capsule, delayed release in 1 bottle43598-509-10Dr. Reddy's LaboratoriesIndia28 April 2016
30 capsule, delayed release in 1 bottle43598-509-30Dr. Reddy's LaboratoriesIndia10 December 2015
90 capsule, delayed release in 1 bottle43598-509-90Dr. Reddy's LaboratoriesIndia27 January 2016
30 capsule, delayed release in 1 bottle70010-133-03Granules IndiaIndia18 October 2023
90 capsule, delayed release in 1 bottle70010-133-09Granules IndiaIndia13 November 2023
1000 capsule, delayed release in 1 bottle70010-133-10Granules IndiaIndia18 October 2023
30 capsule, delayed release in 1 bottle33342-306-07Macleods PharmaceuticalsIndia23 October 2024
90 capsule, delayed release in 1 bottle33342-306-10Macleods PharmaceuticalsIndia23 October 2024
1000 capsule, delayed release in 1 bottle63304-734-10Sun Pharmaceutical IndustriesIndia18 September 2025
30 capsule, delayed release in 1 bottle63304-734-30Sun Pharmaceutical IndustriesIndia18 September 2025
90 capsule, delayed release in 1 bottle63304-734-90Sun Pharmaceutical IndustriesIndia18 September 2025
30 capsule, delayed release pellets in 1 bottle62175-820-32Lannett1 September 2017
1000 capsule, delayed release pellets in 1 bottle62175-820-43Lannett1 September 2017

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 20 February 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 Esomeprazole 20 mg delayed-release capsule.

Compare 1

Other strengths and forms of Esomeprazole

Clinical summary

Esomeprazole is a proton pump inhibitor indicated for the short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age, among other approved uses. MedsAcross supplies Esomeprazole 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 Esomeprazole

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

Data sources

Need Esomeprazole 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.