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MedsAcross

Medicine

Hydrochlorothiazide 12.5 mg tablet

Available on requestPrescription onlyUS FDAGeneric name

Hydrochlorothiazide 12.5 mg tablet is a generic prescription medicine for oral use, made by 19 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).

Key facts

Active ingredient (INN)
Hydrochlorothiazide
Brand
Sold under the generic name
Strength
12.5 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 1000 tablets, 90 tablets and 63 more
Manufacturers
Accord HealthcareIndiaAvet PharmaceuticalsIndiaUnichem LaboratoriesIndiaA-S Medication SolutionsRemedyrepackBryant Ranch PrepackNuCare Pharmaceuticals,IncTeva PharmaceuticalsActavis PharmaLeading Pharma19 labelers on the register
Origin register
US FDA, United States
Storage
Store 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
C03AA03 Hydrochlorothiazide
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
12 March 2007
Identifiers
RxCUI 429503, 197770, 310798DailyMed set ID 4c1a92c0-b491-4ae9-8bd0-029beb2b13c6, 98a58b54-bcf2-4726-800a-facf48d9155f, 099496f1-4e2d-8d21-e063-6294a90af695 +31NDC 0615-8449, 50090-1088, 60760-662 +31Application ANDA040702, ANDA202556, ANDA083177 +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

A sample of 40 packs from 19 labelers. The register lists 66 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet in 1 bottle16729-182-01Accord HealthcareIndia18 April 2013
1000 tablet in 1 bottle16729-182-17Accord HealthcareIndia26 April 2013
100 tablet in 1 bottle23155-764-01Avet PharmaceuticalsIndia2 May 2023
1000 tablet in 1 bottle23155-764-10Avet PharmaceuticalsIndia2 May 2023
100 tablet in 1 bottle29300-485-01Unichem LaboratoriesIndia12 June 2025
1000 tablet in 1 bottle29300-485-10Unichem LaboratoriesIndia12 June 2025
100 tablet in 1 bottle0172-3444-60Teva Pharmaceuticals9 September 2025
1000 tablet in 1 bottle0172-3444-80Teva Pharmaceuticals3 June 2025
1000 tablet in 1 bottle0480-3444-10Teva Pharmaceuticals6 October 2026
100 tablet in 1 bottle0228-2820-11Actavis Pharma12 March 2007
1000 tablet in 1 bottle0228-2820-96Actavis Pharma1 December 2023
90 tablet in 1 bottle62135-738-90Chartwell RX28 July 2023
100 tablet in 1 bottle, plastic69315-155-01Leading Pharma1 November 2019
1000 tablet in 1 bottle, plastic69315-155-10Leading Pharma1 November 2019
30 tablet in 1 bottle50090-1088-0A-S Medication Solutions28 November 2014
100 tablet in 1 bottle50090-1088-2A-S Medication Solutions28 November 2014
90 tablet in 1 bottle50090-1088-3A-S Medication Solutions16 July 2015
30 tablet in 1 bottle50090-6372-0A-S Medication Solutions13 February 2023
100 tablet in 1 bottle50090-6372-2A-S Medication Solutions13 February 2023
90 tablet in 1 bottle50090-6372-3A-S Medication Solutions13 February 2023
90 tablet in 1 bottle50090-6931-0A-S Medication Solutions14 December 2023
30 tablet in 1 bottle50090-7764-0A-S Medication Solutions12 November 2025
100 tablet in 1 bottle50090-7764-2A-S Medication Solutions12 November 2025
90 tablet in 1 bottle50090-7764-3A-S Medication Solutions12 November 2025
90 tablet in 1 bottle50090-7765-0A-S Medication Solutions12 November 2025
30 tablet in 1 bottle50090-7772-0A-S Medication Solutions19 November 2025
100 tablet in 1 bottle50090-7772-2A-S Medication Solutions19 November 2025
90 tablet in 1 bottle50090-7772-3A-S Medication Solutions19 November 2025
90 tablet in 1 bottle50090-7773-0A-S Medication Solutions19 November 2025
90 tablet in 1 bottle50090-7817-0A-S Medication Solutions11 December 2025
30 tablet in 1 bottle68071-3443-3NuCare Pharmaceuticals,Inc21 June 2023
30 tablet in 1 bottle, plastic68071-3608-3NuCare Pharmaceuticals,Inc15 May 2024
100 tablet in 1 bottle, plastic68071-3652-1NuCare Pharmaceuticals,Inc24 July 2024
90 tablet in 1 bottle, plastic70518-4251-0Remedyrepack7 January 2025
30 tablet in 1 blister pack70518-4466-0Remedyrepack4 September 2025
90 tablet in 1 bottle, plastic70518-4466-1Remedyrepack16 October 2025
30 tablet in 1 blister pack70518-4736-0Remedyrepack26 August 2026
30 tablet in 1 bottle63629-7782-1Bryant Ranch Prepack18 November 2021
90 tablet in 1 bottle63629-7782-2Bryant Ranch Prepack14 April 2021
14 tablet in 1 bottle63629-7782-3Bryant Ranch Prepack23 September 2019

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 12 February 1959Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
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

Other strengths and forms of Hydrochlorothiazide

Clinical summary

Hydrochlorothiazide is a thiazide diuretic indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. It is available as tablets, capsules and oral solution. MedsAcross supplies Hydrochlorothiazide 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 Hydrochlorothiazide

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

Data sources

Need Hydrochlorothiazide 12.5 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.