Medicine
Nicardipine 25 mg/10 mL injection
Nicardipine 25 mg/10 mL injection is a generic prescription medicine for intravenous use, made by 15 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Freezing does not adversely affect the product, but avoid exposure to elevated…
Key facts
- Active ingredient (INN)
- Nicardipine
- Brand
- Sold under the generic name
- Strength
- 25 mg/10 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 10 mL, 1 vial of 10 mL, 10 mL and 16 more
- Manufacturers
- EugiaIndiaLifestar PharmaIndiaMicro LabsIndiaChengdu Shuode PharmaceuticalFresenius KabiHikma PharmaceuticalsAmerican RegentArchis PharmaArmas PharmaceuticalsCivica
- Origin register
- US FDA, United States
- Storage
- Freezing does not adversely affect the product, but avoid exposure to elevated temperatures. Store at controlled room temperature 20° to 25°C (68° to 77°F), refer to USP Controlled Room Temperature. Protect from light. Store vials in carton until used.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C08CA04 Nicardipine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 March 2012
- Identifiers
- RxCUI 858607, 858599, 858603DailyMed set ID 76fcb7e0-9034-4fcd-be14-ce7e9ccaee2a, 18fb1c2b-0c1e-436c-a5b6-d4840b5da228, 9d898911-d811-2a78-e053-2995a90af784 +13NDC 0517-0735, 0143-9689, 51662-1482 +13Application ANDA090534, NDA022276, ANDA211121 +6
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 | 55150-183-10 | EugiaIndia | 8 April 2021 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 55150-183-11 | EugiaIndia | 8 April 2021 |
| 10 vial in 1 carton / 10 mL in 1 vial | 70756-686-10 | Lifestar PharmaIndia | 24 February 2026 |
| 10 vial in 1 carton / 10 mL in 1 vial | 42571-394-89 | Micro LabsIndia | 1 November 2023 |
| 10 vial in 1 carton / 10 mL in 1 vial | 0143-9542-10 | Hikma Pharmaceuticals | 2 March 2012 |
| 10 vial in 1 carton / 10 mL in 1 vial | 0143-9689-10 | Hikma Pharmaceuticals | 2 March 2012 |
| 10 vial in 1 carton / 10 mL in 1 vial | 0517-0735-10 | American Regent | 8 May 2020 |
| 10 vial in 1 carton / 10 mL in 1 vial | 72819-149-07 | Archis Pharma | 7 December 2024 |
| 10 vial in 1 carton / 10 mL in 1 vial | 72485-116-10 | Armas Pharmaceuticals | 3 April 2024 |
| 1 vial, glass in 1 carton / 10 mL in 1 vial, glass | 82432-103-01 | Chengdu Shuode Pharmaceutical | 11 September 2024 |
| 10 vial, glass in 1 carton / 10 mL in 1 vial, glass | 82432-103-02 | Chengdu Shuode Pharmaceutical | 17 November 2025 |
| 1 vial, glass in 1 carton / 10 mL in 1 vial, glass | 65219-818-10 | Fresenius Kabi | 11 September 2024 |
| 10 vial, glass in 1 carton / 10 mL in 1 vial, glass | 65219-818-13 | Fresenius Kabi | 17 November 2025 |
| 10 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 71288-204-11 | Meitheal Pharmaceuticals | 20 August 2025 |
| 10 vial in 1 carton / 10 mL in 1 vial | 67184-0611-2 | Qilu Pharmaceutical | 1 January 2026 |
| 10 vial in 1 carton / 10 mL in 1 vial | 25021-333-10 | Sagent Pharmaceuticals | 1 January 2026 |
| 10 vial in 1 carton / 10 mL in 1 vial | 0143-9593-10 | West-Ward Pharmaceuticals | 2 March 2012 |
| 10 vial in 1 carton / 10 mL in 1 vial | 72572-470-10 | Civica | 29 October 2020 |
| 10 mL in 1 vial | 51662-1482-1 | HealthFirst | 1 February 2020 |
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 21 December 1988 | 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 Nicardipine
Clinical summary
Nicardipine is a dihydropyridine calcium channel blocker indicated for the short-term treatment of hypertension in adults when oral therapy is not feasible. It is available as injection and capsules for intravenous and oral use. MedsAcross supplies Nicardipine 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 NicardipineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- CARDENE IV prescribing information (Baxter Healthcare) · U.S. National Library of Medicine, DailyMed
Need Nicardipine 25 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.