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Medicine

Diltiazem 360 mg extended-release capsule

Diltiazem · Oral
Available on requestPrescription onlyUS FDAGeneric name

Diltiazem 360 mg extended-release capsule is a generic prescription medicine for oral use, made by 10 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 between 15° and 30°C…

Key facts

Active ingredient (INN)
Diltiazem
Brand
Sold under the generic name
Strength
360 mg
Dosage form
Extended-release capsule
Route
Oral
Packs
500 capsules, 1000 capsules, 90 capsules and 42 more
Manufacturers
Sun Pharmaceutical IndustriesIndiaZydus LifesciencesIndiaAlembic PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaIngenus PharmaceuticalsUpsher-Smith LaboratoriesActavis PharmaOceanside Pharmaceuticals10 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
C05AE03 Diltiazem
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
15 November 2010
Identifiers
RxCUI 830795, 830801, 830837 +3DailyMed set ID eebf29fe-ce22-4482-b850-5854550bf2c4, 6f71ba5e-7bd6-409a-80c6-2f22d975aefc, 850566b1-0c8e-42bc-85fa-c8ee710f34ba +12NDC 47335-673, 47335-679, 33342-525 +12Application ANDA090421, ANDA090492, ANDA218744 +7

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 10 labelers. The register lists 45 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
500 capsule, extended release in 1 bottle47335-673-13Sun Pharmaceutical IndustriesIndia15 November 2010
1000 capsule, extended release in 1 bottle47335-673-18Sun Pharmaceutical IndustriesIndia15 November 2010
90 capsule, extended release in 1 bottle47335-673-19Sun Pharmaceutical IndustriesIndia15 November 2010
90 capsule, extended release in 1 bottle47335-673-81Sun Pharmaceutical IndustriesIndia15 November 2010
30 capsule, extended release in 1 bottle47335-673-83Sun Pharmaceutical IndustriesIndia15 November 2010
500 capsule, extended release in 1 bottle47335-679-13Sun Pharmaceutical IndustriesIndia31 October 2011
1000 capsule, extended release in 1 bottle47335-679-18Sun Pharmaceutical IndustriesIndia31 October 2011
90 capsule, extended release in 1 bottle47335-679-19Sun Pharmaceutical IndustriesIndia31 October 2011
90 capsule, extended release in 1 bottle47335-679-81Sun Pharmaceutical IndustriesIndia31 October 2011
30 capsule, extended release in 1 bottle47335-679-83Sun Pharmaceutical IndustriesIndia31 October 2011
500 capsule, extended release in 1 bottle63304-722-05Sun Pharmaceutical IndustriesIndia31 October 2018
30 capsule, extended release in 1 bottle63304-722-30Sun Pharmaceutical IndustriesIndia31 October 2018
90 capsule, extended release in 1 bottle63304-722-90Sun Pharmaceutical IndustriesIndia31 October 2018
30 capsule, extended release in 1 bottle46708-729-30Alembic PharmaceuticalsIndia14 November 2024
90 capsule, extended release in 1 bottle46708-729-90Alembic PharmaceuticalsIndia14 November 2024
1000 capsule, extended release in 1 bottle46708-729-91Alembic PharmaceuticalsIndia14 November 2024
30 capsule, extended release in 1 bottle62332-729-30Alembic PharmaceuticalsIndia14 November 2024
90 capsule, extended release in 1 bottle62332-729-90Alembic PharmaceuticalsIndia14 November 2024
1000 capsule, extended release in 1 bottle62332-729-91Alembic PharmaceuticalsIndia14 November 2024
100 capsule, extended release in 1 bottle68382-599-01Zydus LifesciencesIndia28 September 2017
500 capsule, extended release in 1 bottle68382-599-05Zydus LifesciencesIndia2 October 2018
30 capsule, extended release in 1 bottle68382-599-06Zydus LifesciencesIndia28 September 2017
90 capsule, extended release in 1 bottle68382-599-16Zydus LifesciencesIndia28 September 2017
10 blister pack in 1 carton / 10 capsule, extended release in 1 blister pack68382-599-77Zydus LifesciencesIndia28 September 2017
100 capsule, extended release in 1 bottle70771-1034-1Zydus LifesciencesIndia28 September 2017
30 capsule, extended release in 1 bottle70771-1034-3Zydus LifesciencesIndia28 September 2017
10 blister pack in 1 carton / 10 capsule, extended release in 1 blister pack70771-1034-4Zydus LifesciencesIndia28 September 2017
500 capsule, extended release in 1 bottle70771-1034-5Zydus LifesciencesIndia2 October 2018
90 capsule, extended release in 1 bottle70771-1034-9Zydus LifesciencesIndia28 September 2017
6 capsule, extended release in 1 blister pack33342-525-02Macleods PharmaceuticalsIndia23 June 2023
30 capsule, extended release in 1 bottle33342-525-07Macleods PharmaceuticalsIndia23 June 2023
90 capsule, extended release in 1 bottle33342-525-10Macleods PharmaceuticalsIndia23 June 2023
90 capsule, extended release in 1 bottle0228-2918-09Actavis Pharma25 November 2013
500 capsule, extended release in 1 bottle50742-252-05Ingenus Pharmaceuticals14 June 2019
1000 capsule, extended release in 1 bottle50742-252-10Ingenus Pharmaceuticals14 June 2019
30 capsule, extended release in 1 bottle50742-252-30Ingenus Pharmaceuticals14 June 2019
90 capsule, extended release in 1 bottle50742-252-90Ingenus Pharmaceuticals14 June 2019
90 capsule, extended release in 1 bottle, plastic68682-371-90Oceanside Pharmaceuticals20 August 2014
21000 capsule, extended release in 1 drum24979-030-00Upsher-Smith Laboratories1 July 2024
90 capsule, extended release in 1 bottle24979-030-07Upsher-Smith Laboratories1 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 5 November 1982Drugs@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

Alternatives

Other makers and brands of Diltiazem 360 mg extended-release capsule.

Compare all 3

Other strengths and forms of Diltiazem

Clinical summary

Diltiazem is a calcium channel blocker indicated for the management of chronic stable angina and angina due to coronary artery spasm. It is available as extended-release capsules, tablets and extended-release tablets for oral and intravenous use. MedsAcross supplies Diltiazem 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 Diltiazem

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

Data sources

Need Diltiazem 360 mg extended-release 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.