United States· US:65145-197_9383f1dc-0310-4c87-a8f0-48c09a85d89b
Nicardipine Hydrochloride
A nicardipine product containing nicardipine hydrochloride, registered in United States by Caplin Steriles Limited. The same ATC class is registered in 8 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Nicardipine is registered in 8 of 19 countries.
Countries holding a registration under ATC C08CA04 (nicardipine), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 5 of them publish a price we can compare per daily dose
Nicardipine · ATC C08CA04
8 / 19 countries
- Belgiumprice
- Franceprice
- Japan
- Netherlands
- Norwayprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- Nicardipine Hydrochloride
- Manufacturer
- Caplin Steriles Limited
- Country
- United States (US)
- ATC code
- C08CA04
- ATC class
- Nicardipine
- Defined daily dose
- 90 mg, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 12, 2026
Packs & prices · 1
- ndc1165145197011 BAG in 1 POUCH (65145-197-01) / 200 mL in 1 BAG
Regulatory notes
Interactions
228 interactions on record for nicardipine.
Graded by severity as the source publishes them — 8 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Nicardipine · interactions on record
228 records
- 8 severe
- 173 moderate
- 1 minor
- 46 info
Most severe, free to view
- DolasetronA04AA04severe
- CeritinibL01ED02severe
- CeritinibL01XE28severe
- MitotaneL01XX23severe
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Nicardipine in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomCardene 20mg capsulesLaboratoire X.O
- SpainFLUSEMIDE 20 mg COMPRIMIDOSLaboratorios Q Pharma S.L.
- FranceLOXEN 10 mg/10 mL, solution injectable (I.V.)LABORATOIRE XO
- BelgiumNicardipine Aguettant 10 mg/10 mlLaboratoire Aguettant
- SwitzerlandNicardipin Aguettant 10 mg/10 ml, solution injectableAguettant Suisse SA
- ItalyNICARDIPINA*30 cps 40 mg rilascio prolungatoMYLAN SpA
- NetherlandsCardene IV, 1 mg/ml oplossing voor infusieLaboratoire X.O.
- NorwayNicardipine HCl hikmaHikma
Authorised across Europe · EMA
The same active substance is authorised in 7 EEA countries. Names it is sold under:
- Belgium · Nicardipine Aguettant, Nicardipine Hikma
- Spain · Flusemide, Nerdipina Retard
- France · Loxen, Loxen Lp
- United Kingdom (Northern Ireland) · Nicardipine Hydrochloride Tillomed Laboratories, Nicardipine Laboratoire Aguettant
- Italy · Nicardipina Mylan Generics
- Luxembourg · Nicardipine Aguettant, Rydene Iv
- Netherlands · Cardene Iv
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/bd79ea3a-0adf-4ac0-8c35-5976283fbbd4 GET /v1/drugs/bd79ea3a-0adf-4ac0-8c35-5976283fbbd4?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"unii": {
"unii": "K5BC5011K3",
"rxcui": "235230",
"inchikey": "AIKVCUNQWYTVTO-UHFFFAOYSA-N",
"display_name": "NICARDIPINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"livertox": {
"summary": null,
"livertox_id": null,
"hepatotoxicity_score": 5
},
"spl_meta": {
"b0e2bed3-f928-43ab-a05c-275bedc9856f": {
"match": "brand_token",
"title": "NICARDIPINE HYDROCHLORIDE INJECTION [LIFESTAR PHARMA LLC]",
"spl_version": "3",
"published_date": "2026-04-27"
}
},
"productid": "65145-197_9383f1dc-0310-4c87-a8f0-48c09a85d89b",
"productndc": "65145-197",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "220243",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "20MG/200ML (0.1MG/ML)",
"product_no": "001",
"approval_date": "Oct 22, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "40MG/200ML (0.2MG/ML)",
"product_no": "002",
"approval_date": "Oct 22, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NICARDIPINE HYDROCHLORIDE",
"proprietary_name": "Nicardipine Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA220243",
"marketing_category": "ANDA",
"nonproprietary_name": "Nicardipine Hydrochloride",
"start_marketing_date": "20251104",
"active_numerator_strength": ".1"
}See everything about nicardipine.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.