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Medicine

Pantoprazole 40 mg/10 mL powder for injection

Pantoprazole · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

Pantoprazole 40 mg/10 mL powder for injection is a generic prescription medicine for intravenous use, made by 11 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 for injection at 20° to 25°C (68° to 77°F)…

Key facts

Active ingredient (INN)
Pantoprazole
Brand
Sold under the generic name
Strength
40 mg/10 mL
Dosage form
Powder for injection
Route
Intravenous
Packs
1 vial, 10 vials, 25 vials and 26 more
Manufacturers
Alembic PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaGland PharmaIndiaNovadoz PharmaceuticalsIndiaBE PharmaceuticalsDevatisMeitheal PharmaceuticalsSagent PharmaceuticalsAvenacyFresenius Kabi
Origin register
US FDA, United States
Storage
Store Pantoprazole sodium for injection at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light.
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
1 September 2019
Identifiers
RxCUI 283669DailyMed set ID 1172bc4e-1700-402f-8262-97f05bac0d09, 70378eba-3904-4491-9f6d-00f5d1501c4a, c39be14b-e881-4586-b77e-4747db494954 +11NDC 72205-180, 83634-751, 25021-751 +10Application ANDA216171, ANDA219973, ANDA204400 +5

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
1 vial in 1 carton / 10 mL in 1 vial46708-071-01Alembic PharmaceuticalsIndia31 March 2025
10 vial in 1 carton / 10 mL in 1 vial46708-071-10Alembic PharmaceuticalsIndia31 March 2025
25 vial in 1 carton / 10 mL in 1 vial46708-071-25Alembic PharmaceuticalsIndia31 March 2025
1 vial in 1 carton / 10 mL in 1 vial62332-071-01Alembic PharmaceuticalsIndia31 March 2025
10 vial in 1 carton / 10 mL in 1 vial62332-071-10Alembic PharmaceuticalsIndia31 March 2025
25 vial in 1 carton / 10 mL in 1 vial62332-071-25Alembic PharmaceuticalsIndia31 March 2025
1 vial in 1 carton / 10 mL in 1 vial62756-129-40Sun Pharmaceutical IndustriesIndia1 September 2019
10 vial in 1 carton / 10 mL in 1 vial62756-129-44Sun Pharmaceutical IndustriesIndia1 September 2019
25 carton in 1 package / 1 vial in 1 carton / 10 mL in 1 vial62756-129-45Sun Pharmaceutical IndustriesIndia1 September 2019
10 carton in 1 package / 1 vial in 1 carton / 10 mL in 1 vial70095-024-02Sun Pharmaceutical IndustriesIndia3 April 2023
25 carton in 1 package / 1 vial in 1 carton / 10 mL in 1 vial70095-024-03Sun Pharmaceutical IndustriesIndia3 April 2023
1 vial in 1 carton / 10 mL in 1 vial68083-493-01Gland PharmaIndia18 May 2022
10 carton in 1 package / 1 vial in 1 carton / 10 mL in 1 vial68083-493-10Gland PharmaIndia18 May 2022
25 carton in 1 package / 1 vial in 1 carton / 10 mL in 1 vial68083-493-25Gland PharmaIndia18 May 2022
10 vial in 1 carton / 10 mL in 1 vial72205-180-07Novadoz PharmaceuticalsIndia19 May 2022
25 vial in 1 carton / 10 mL in 1 vial72205-180-09Novadoz PharmaceuticalsIndia19 May 2022
10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose71288-600-11Meitheal Pharmaceuticals29 August 2022
10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose71288-600-92Meitheal Pharmaceuticals29 August 2022
1 vial in 1 carton / 10 mL in 1 vial71839-122-01BE Pharmaceuticals25 May 2022
10 carton in 1 package / 1 vial in 1 carton / 10 mL in 1 vial71839-122-10BE Pharmaceuticals25 May 2022
25 carton in 1 package / 1 vial in 1 carton / 10 mL in 1 vial71839-122-25BE Pharmaceuticals25 May 2022
1 vial in 1 carton / 10 mL in 1 vial73043-020-01Devatis1 August 2025
10 vial in 1 carton / 10 mL in 1 vial73043-020-10Devatis1 August 2025
25 vial in 1 carton / 10 mL in 1 vial73043-020-25Devatis1 August 2025
10 vial in 1 carton / 10 mL in 1 vial65219-385-10Fresenius Kabi31 January 2025
10 vial in 1 carton / 10 mL in 1 vial25021-751-10Sagent Pharmaceuticals15 July 2022
25 vial in 1 carton / 10 mL in 1 vial25021-751-11Sagent Pharmaceuticals15 July 2022
10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose83634-751-10Avenacy30 September 2026
10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose72603-128-10Northstar Rx29 August 2022

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/10 mL powder for injection.

Compare all 3

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/10 mL powder for injection 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.