Medicine
Diltiazem 50 mg/10 mL injection
Diltiazem 50 mg/10 mL injection is a generic prescription medicine for intravenous use, made by 3 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Destroy…
Key facts
- Active ingredient (INN)
- Diltiazem
- Brand
- Sold under the generic name
- Strength
- 50 mg/10 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 10 mL and 1 more
- Manufacturers
- EugiaIndiaHikma PharmaceuticalsSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Destroy after 1 month at room temperature. May be stored at room temperature for up to 1 month.
- Cold chain
- Yes, shipped temperature controlled
- 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
- 17 December 2008
- Identifiers
- RxCUI 1791229, 1791232, 1791233DailyMed set ID 9d51c0f6-26b7-4220-83fb-4e736b289e64, 453b73bd-c52d-4d72-a0b3-47588e723e0b, f8d962ab-6cd4-43a1-a8fa-fb6548ac2a08 +1NDC 25021-319, 0641-6014, 55150-426 +1Application ANDA074617, ANDA078538, ANDA216552
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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 55150-426-10 | EugiaIndia | 29 March 2023 |
| 10 vial in 1 carton / 10 mL in 1 vial | 0641-6014-10 | Hikma Pharmaceuticals | 17 December 2008 |
| 10 vial in 1 carton / 10 mL in 1 vial | 0641-9218-10 | Hikma Pharmaceuticals | 17 December 2008 |
| 10 vial in 1 carton / 10 mL in 1 vial | 25021-319-10 | Sagent Pharmaceuticals | 1 June 2024 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 5 November 1982 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 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 DiltiazemFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Cardizem prescribing information (Bausch Health) · U.S. National Library of Medicine, DailyMed
Need Diltiazem 50 mg/10 mL 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.