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Medicine

Pioglitazone 45 mg tablet

Pioglitazone · Oral
Available on requestPrescription onlyUS FDAGeneric name

Pioglitazone 45 mg tablet is a generic prescription medicine for oral use, made by 14 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)
Pioglitazone
Brand
Sold under the generic name
Strength
45 mg
Dosage form
Tablet
Route
Oral
Packs
500 tablets, 3 blister pack, 30 tablets and 37 more
Manufacturers
Aurobindo PharmaIndiaMacleods PharmaceuticalsIndiaUnichem LaboratoriesIndiaA-S Medication SolutionsBryant Ranch PrepackGsmsNorthStar RxLLCRising Pharma HoldingsSolco HealthcareTeva Pharmaceuticals
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). Keep container tightly closed, and protect from light, moisture and humidity.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
A10BG03 Pioglitazone
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
13 February 2013
Identifiers
RxCUI 312440, 312441, 317573DailyMed set ID 482cef76-0623-4b4f-a0ea-f008c97b2281, 0331400c-b163-4856-bfb0-965470247cb3, 692e662a-3b31-42c3-a075-42abe44c74db +12NDC 33342-056, 82009-105, 16714-647 +12Application ANDA202467, ANDA200268, ANDA210165 +3

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
500 tablet in 1 bottle65862-514-05Aurobindo PharmaIndia13 February 2013
3 blister pack in 1 carton / 10 tablet in 1 blister pack65862-514-10Aurobindo PharmaIndia13 February 2013
30 tablet in 1 bottle65862-514-30Aurobindo PharmaIndia13 February 2013
90 tablet in 1 bottle65862-514-90Aurobindo PharmaIndia13 February 2013
30 tablet in 1 bottle33342-056-07Macleods PharmaceuticalsIndia14 February 2013
90 tablet in 1 bottle33342-056-10Macleods PharmaceuticalsIndia14 February 2013
100 tablet in 1 box, unit-dose33342-056-12Macleods PharmaceuticalsIndia14 February 2013
500 tablet in 1 bottle33342-056-15Macleods PharmaceuticalsIndia14 February 2013
1000 tablet in 1 bottle76385-180-10Unichem LaboratoriesIndia25 June 2026
30 tablet in 1 bottle76385-180-30Unichem LaboratoriesIndia25 June 2026
500 tablet in 1 bottle76385-180-50Unichem LaboratoriesIndia25 June 2026
90 tablet in 1 bottle76385-180-90Unichem LaboratoriesIndia25 June 2026
30 tablet in 1 bottle62135-806-30Chartwell RX22 August 2024
90 tablet in 1 bottle62135-806-90Chartwell RX22 August 2024
500 tablet in 1 bottle84677-028-05Gsms20 June 2026
30 tablet in 1 bottle84677-028-30Gsms20 June 2026
90 tablet in 1 bottle84677-028-90Gsms20 June 2026
500 tablet in 1 bottle57237-221-05Rising Pharma Holdings13 February 2013
30 tablet in 1 bottle57237-221-30Rising Pharma Holdings13 February 2013
90 tablet in 1 bottle57237-221-90Rising Pharma Holdings13 February 2013
30 tablet in 1 bottle43547-428-03Solco Healthcare20 May 2018
90 tablet in 1 bottle43547-428-09Solco Healthcare20 May 2018
500 tablet in 1 bottle43547-428-50Solco Healthcare20 May 2018
500 tablet in 1 bottle0093-7273-05Teva Pharmaceuticals22 May 2015
30 tablet in 1 bottle0093-7273-56Teva Pharmaceuticals29 September 2015
90 tablet in 1 bottle0093-7273-98Teva Pharmaceuticals28 July 2015
30 tablet in 1 bottle50090-6384-0A-S Medication Solutions3 March 2023
90 tablet in 1 bottle50090-6384-1A-S Medication Solutions3 March 2023
30 tablet in 1 bottle50090-6412-0A-S Medication Solutions28 March 2023
90 tablet in 1 bottle50090-6412-1A-S Medication Solutions28 March 2023
30 tablet in 1 bottle42291-961-30AvKARE17 September 2024
500 tablet in 1 bottle42291-961-50AvKARE17 September 2024
30 tablet in 1 bottle71335-1759-1Bryant Ranch Prepack10 March 2022
90 tablet in 1 bottle71335-1759-2Bryant Ranch Prepack10 March 2022
180 tablet in 1 bottle71335-1759-3Bryant Ranch Prepack10 March 2022
30 tablet in 1 bottle16714-647-01NorthStar RxLLC18 August 2022
90 tablet in 1 bottle16714-647-02NorthStar RxLLC18 August 2022
500 tablet in 1 bottle16714-647-03NorthStar RxLLC18 August 2022
500 tablet in 1 bottle82009-105-05Quallent Pharmaceuticals Health1 August 2023
90 tablet in 1 bottle, plastic70518-4519-0Remedyrepack14 November 2025

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 15 July 1999Drugs@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 Pioglitazone 45 mg tablet.

Compare 1

Other strengths and forms of Pioglitazone

Clinical summary

Pioglitazone is a peroxisome proliferator receptor alpha agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. MedsAcross supplies Pioglitazone 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 Pioglitazone

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

Data sources

Need Pioglitazone 45 mg 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.