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Medicine

Pantoprazole 40 mg delayed-release tablet

Pantoprazole · Oral
Available on requestPrescription onlyUS FDAGeneric name

Pantoprazole 40 mg delayed-release tablet is a generic prescription medicine for oral use, made by 42 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 pantoprazole sodium delayed-release tablets, USP at 20° to 25°C (68° to…

Key facts

Active ingredient (INN)
Pantoprazole
Brand
Sold under the generic name
Strength
40 mg
Dosage form
Delayed-release tablet
Route
Oral
Packs
500 tablets, 10 blister pack, 90 tablets and 181 more
Manufacturers
Dr. Reddy's LaboratoriesIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaTorrent PharmaceuticalsIndiaGranules IndiaIndiaAmneal PharmaceuticalsNuCare Pharmaceuticals,IncChartwell RXLannettMylan Pharmaceuticals42 labelers on the register
Origin register
US FDA, United States
Storage
Store pantoprazole sodium delayed-release tablets, USP at 20° to 25°C (68° to 77°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
A02BC02 Pantoprazole
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
19 January 2011
Identifiers
RxCUI 314200, 251872DailyMed set ID 0515ceaa-7d17-c92f-e063-6294a90a044e, 82f0103a-2b97-d210-6d7d-c627d60ad694, c9bc288b-e84c-4e31-a769-c87a59226086 +37NDC 72189-514, 72603-178, 43353-027 +37Application ANDA202882, ANDA077619, ANDA078281 +6

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 42 labelers. The register lists 184 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
500 tablet, delayed release in 1 bottle65862-560-05Aurobindo PharmaIndia4 December 2025
10 blister pack in 1 carton / 10 tablet, delayed release in 1 blister pack65862-560-10Aurobindo PharmaIndia28 September 2012
90 tablet, delayed release in 1 bottle65862-560-90Aurobindo PharmaIndia28 September 2012
1000 tablet, delayed release in 1 bottle65862-560-99Aurobindo PharmaIndia28 September 2012
1000 tablet, delayed release in 1 bottle31722-713-10Camber PharmaceuticalsIndia10 September 2014
10 tablet, delayed release in 1 blister pack31722-713-31Camber PharmaceuticalsIndia10 September 2014
10 tablet, delayed release in 1 carton31722-713-32Camber PharmaceuticalsIndia10 September 2014
90 tablet, delayed release in 1 bottle31722-713-90Camber PharmaceuticalsIndia10 September 2014
100 tablet, delayed release in 1 bottle55111-333-01Dr. Reddy's LaboratoriesIndia19 January 2011
500 tablet, delayed release in 1 bottle55111-333-05Dr. Reddy's LaboratoriesIndia19 January 2011
1000 tablet, delayed release in 1 bottle55111-333-10Dr. Reddy's LaboratoriesIndia1 May 2026
30 tablet, delayed release in 1 bottle55111-333-30Dr. Reddy's LaboratoriesIndia19 January 2011
10 blister pack in 1 carton / 10 tablet, delayed release in 1 blister pack55111-333-78Dr. Reddy's LaboratoriesIndia19 January 2011
3 blister pack in 1 carton / 10 tablet, delayed release in 1 blister pack55111-333-81Dr. Reddy's LaboratoriesIndia19 January 2011
90 tablet, delayed release in 1 bottle55111-333-90Dr. Reddy's LaboratoriesIndia19 January 2011
90 tablet, delayed release in 1 bottle70010-191-09Granules IndiaIndia12 April 2024
1000 tablet, delayed release in 1 bottle70010-191-10Granules IndiaIndia12 April 2024
500 tablet, delayed release in 1 bottle13668-429-05Torrent PharmaceuticalsIndia20 January 2011
30 tablet, delayed release in 1 bottle13668-429-30Torrent PharmaceuticalsIndia20 January 2011
90 tablet, delayed release in 1 bottle13668-429-90Torrent PharmaceuticalsIndia20 January 2011
30 tablet, delayed release in 1 bottle65162-637-03Amneal Pharmaceuticals20 June 2016
90 tablet, delayed release in 1 bottle65162-637-09Amneal Pharmaceuticals20 June 2016
1000 tablet, delayed release in 1 bottle65162-637-11Amneal Pharmaceuticals20 June 2016
500 tablet, delayed release in 1 bottle65162-637-50Amneal Pharmaceuticals20 June 2016
10 blister pack in 1 carton / 10 tablet, delayed release in 1 blister pack35573-428-80Burel Pharmaceuticals20 April 2020
450 tablet, delayed release in 1 bottle62135-534-08Chartwell RX5 April 2023
90 tablet, delayed release in 1 bottle62135-534-90Chartwell RX5 April 2023
1000 tablet, delayed release in 1 bottle62175-617-43Lannett20 January 2011
90 tablet, delayed release in 1 bottle62175-617-46Lannett20 January 2011
100 blister pack in 1 carton / 1 tablet, delayed release in 1 blister pack51079-051-20Mylan Institutional23 February 2011
1000 tablet, delayed release in 1 bottle, plastic0378-6689-10Mylan Pharmaceuticals19 January 2011
90 tablet, delayed release in 1 bottle, plastic0378-6689-77Mylan Pharmaceuticals19 January 2011
90 tablet, delayed release in 1 bottle64980-677-09Rising Pharma Holdings12 March 2025
1000 tablet, delayed release in 1 bottle64980-677-10Rising Pharma Holdings21 April 2025
1000 tablet, delayed release in 1 bottle72865-230-10XLCare Pharmaceuticals1 May 2022
90 tablet, delayed release in 1 bottle72865-230-90XLCare Pharmaceuticals1 May 2022
30 tablet, delayed release in 1 bottle68071-1963-3NuCare Pharmaceuticals20 January 2011
14 tablet, delayed release in 1 bottle68071-1963-4NuCare Pharmaceuticals20 January 2011
60 tablet, delayed release in 1 bottle68071-1963-6NuCare Pharmaceuticals20 January 2011
30 tablet, delayed release in 1 bottle68071-2215-3NuCare Pharmaceuticals,Inc8 July 2020

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 2 February 2000Drugs@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 Pantoprazole 40 mg delayed-release tablet.

Compare 1

Other strengths and forms of Pantoprazole

Clinical summary

Pantoprazole is a proton pump inhibitor indicated for pROTONIX is a proton pump inhibitor (PPI) indicated for the following, among other approved uses. MedsAcross supplies Pantoprazole 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 Pantoprazole

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

Data sources

Need Pantoprazole 40 mg delayed-release 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.