Medicine
Nicardipine 40 mg/200 mL injection
Nicardipine 40 mg/200 mL injection is a generic prescription medicine for intravenous use, made by 6 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 exposure to elevated…
Key facts
- Active ingredient (INN)
- Nicardipine
- Brand
- Sold under the generic name
- Strength
- 40 mg/200 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 pouches of 200 mL, 10 bags of 200 mL, 12 bags of 200 mL and 3 more
- Manufacturers
- Caplin SterilesIndiaCiplaIndiaFresenius KabiHikma PharmaceuticalsSomerset TherapeuticsWG Critical Care
- Origin register
- US FDA, United States
- Storage
- Freezing does not adversely affect the product, but exposure to elevated temperatures should be avoided. Store at 20° to 25°C (68° to 77°F). Protect from light. Store in overwrap until ready to use.
- 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
- 7 April 2016
- Identifiers
- RxCUI 858599, 858603, 858607DailyMed set ID 6fd1dafe-4b51-49c7-bce1-c4295b2bd292, 570af1f8-6718-4b40-ae89-0f738d330ebd, 9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d +3NDC 65219-298, 69097-008, 44567-851 +3Application ANDA219334, ANDA215592, ANDA203978 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 pouch in 1 case / 1 bag in 1 pouch / 200 mL in 1 bag | 65145-198-10 | Caplin SterilesIndia | 25 June 2026 |
| 10 bag in 1 carton / 200 mL in 1 bag | 69097-008-22 | CiplaIndia | 2 October 2024 |
| 10 bag in 1 case / 200 mL in 1 bag | 65219-298-20 | Fresenius Kabi | 1 October 2026 |
| 10 bag in 1 carton / 200 mL in 1 bag | 0143-9633-10 | Hikma Pharmaceuticals | 7 April 2016 |
| 10 pouch in 1 case / 1 bag in 1 pouch / 200 mL in 1 bag | 70069-876-10 | Somerset Therapeutics | 20 April 2026 |
| 12 bag in 1 carton / 200 mL in 1 bag | 44567-851-12 | WG Critical Care | 10 July 2025 |
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
Alternatives
Other makers and brands of Nicardipine 40 mg/200 mL injection.
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 40 mg/200 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.