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Medicine

Hydrochlorothiazide 12.5 mg capsule

Available on requestPrescription onlyUS FDAGeneric name

Hydrochlorothiazide 12.5 mg capsule 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

Protect from light, moisture, freezing, -20°C (-4°F). Store at 20°- 25°C…

Key facts

Active ingredient (INN)
Hydrochlorothiazide
Brand
Sold under the generic name
Strength
12.5 mg
Dosage form
Capsule
Route
Oral
Packs
10 blister pack, 30 capsules, 100 capsules and 114 more
Manufacturers
Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaUnichem LaboratoriesIndiaBryant Ranch PrepackScieGen PharmaceuticalsRising Pharma HoldingsActavis Pharma19 labelers on the register
Origin register
US FDA, United States
Storage
Protect from light, moisture, freezing, -20°C (-4°F). Store at 20°- 25°C (68°-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
27 December 1996
Identifiers
RxCUI 199903DailyMed set ID c1052d38-fd75-40c2-a685-0e889009be0b, 45316037-52ec-438f-8780-b2e983fef3f5, a3eb7294-f913-434b-896c-da028bfebc73 +32NDC 63187-548, 72162-1528, 0591-0347 +32Application NDA020504, ANDA203561, ANDA078164 +2

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 117 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
10 blister pack in 1 carton / 10 capsule in 1 blister pack46708-438-10Alembic PharmaceuticalsIndia2 March 2017
30 capsule in 1 bottle46708-438-30Alembic PharmaceuticalsIndia2 March 2017
100 capsule in 1 bottle46708-438-31Alembic PharmaceuticalsIndia2 March 2017
500 capsule in 1 bottle46708-438-71Alembic PharmaceuticalsIndia2 March 2017
1000 capsule in 1 bottle46708-438-91Alembic PharmaceuticalsIndia2 March 2017
10 blister pack in 1 carton / 10 capsule in 1 blister pack62332-070-10Alembic PharmaceuticalsIndia2 March 2017
30 capsule in 1 bottle62332-070-30Alembic PharmaceuticalsIndia2 March 2017
100 capsule in 1 bottle62332-070-31Alembic PharmaceuticalsIndia2 March 2017
500 capsule in 1 bottle62332-070-71Alembic PharmaceuticalsIndia2 March 2017
1000 capsule in 1 bottle62332-070-91Alembic PharmaceuticalsIndia2 March 2017
100 capsule in 1 bottle65862-113-01Aurobindo PharmaIndia19 September 2007
500 capsule in 1 bottle65862-113-05Aurobindo PharmaIndia19 September 2007
300 capsule in 1 bottle65862-113-33Aurobindo PharmaIndia19 September 2007
1000 capsule in 1 bottle65862-113-99Aurobindo PharmaIndia19 September 2007
100 capsule in 1 bottle, plastic29300-130-01Unichem LaboratoriesIndia15 March 2010
500 capsule in 1 bottle, plastic29300-130-05Unichem LaboratoriesIndia15 March 2010
1000 capsule in 1 bottle, plastic29300-130-10Unichem LaboratoriesIndia15 March 2010
100 capsule, gelatin coated in 1 bottle0591-0347-01Actavis Pharma27 December 1996
500 capsule, gelatin coated in 1 bottle0591-0347-05Actavis Pharma27 December 1996
100 capsule in 1 bottle57237-002-01Rising Pharma Holdings19 September 2007
500 capsule in 1 bottle57237-002-05Rising Pharma Holdings19 September 2007
1000 capsule in 1 bottle57237-002-99Rising Pharma Holdings19 September 2007
100 capsule in 1 bottle50228-146-01ScieGen Pharmaceuticals14 January 2019
500 capsule in 1 bottle50228-146-05ScieGen Pharmaceuticals14 January 2019
1000 capsule in 1 bottle50228-146-10ScieGen Pharmaceuticals14 January 2019
30 capsule in 1 bottle50228-146-30ScieGen Pharmaceuticals14 January 2019
500 capsule in 1 bottle63629-8498-1Bryant Ranch Prepack18 May 2021
30 capsule in 1 bottle71335-0067-1Bryant Ranch Prepack3 April 2018
10 capsule in 1 bottle71335-0067-2Bryant Ranch Prepack29 May 2024
90 capsule in 1 bottle71335-0067-3Bryant Ranch Prepack3 April 2018
100 capsule in 1 bottle71335-0067-4Bryant Ranch Prepack12 August 2020
60 capsule in 1 bottle71335-0067-5Bryant Ranch Prepack29 May 2024
120 capsule in 1 bottle71335-0067-6Bryant Ranch Prepack6 August 2020
7 capsule in 1 bottle71335-0067-7Bryant Ranch Prepack29 May 2024
15 capsule in 1 bottle71335-0067-8Bryant Ranch Prepack29 May 2024
14 capsule in 1 bottle71335-0067-9Bryant Ranch Prepack5 March 2021
30 capsule in 1 bottle71335-0770-1Bryant Ranch Prepack13 April 2018
10 capsule in 1 bottle71335-0770-2Bryant Ranch Prepack7 May 2018
90 capsule in 1 bottle71335-0770-3Bryant Ranch Prepack10 April 2018
100 capsule in 1 bottle71335-0770-4Bryant Ranch Prepack1 October 2018

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 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.