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NICARDIPINE HYDROCHLORIDE 25 mg/10mL Injection — NDC 82432-0103-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

NICARDIPINE HYDROCHLORIDE 25 mg/10mL Injection — NDC 82432-103-02 (Billing 82432-0103-02)

by Chengdu Shuode Pharmaceutical Co., Ltd · 10 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS

This is a package of NICARDIPINE HYDROCHLORIDE 25 mg/10mL Injection from Chengdu Shuode Pharmaceutical Co., Ltd, marketed since Sep 2024 and currently FDA-listed.

NDC 82432-0103-02
🏷️ FDA NDC (as labeled) 82432-103-02 billing pads the product segment with a zero
This package
Contains10 mL in 1 vial, glass Pack sizes2 compare ↓
Product page 82432-0103-01 Also comes in: 10 mL 82432-103-01
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Nicardipine Hydrochloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 6, 2026 — CGMP Deviations (Baxter Healthcare Corporation) · FDA recall D-0813-2026
Class II · Jul 24, 2026 — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde (American Regent, Inc.) · FDA recall D-0802-2026
Class II · Apr 18, 2025 — Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. (American Regent, Inc.) · FDA recall D-0398-2025
Class II · Apr 18, 2025 — Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. (American Regent, Inc.) · FDA recall D-0399-2025
Class II · Feb 20, 2024 — Failed Impurities/Degradation Specifications: Out of specification for organic impurities (Eugia US LLC) · FDA recall D-0391-2024
Class II · Feb 20, 2024 — Failed Impurities/Degradation Specifications: Out of specification for organic impurities (Eugia US LLC) · FDA recall D-0390-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82432-103-02
Product NDC 82432-103
11-digit billing NDC 82432010302
RxCUI 858607
UNII K5BC5011K3
Application # ANDA217548
SPL Set ID 433dbca3-0a86-44c2-835d-1051c1c93878
Established class (EPC) Dihydropyridine Calcium Channel Blocker; Dihydropyridines [CS
Mechanism of action Calcium Channel Antagonists; Cytochrome P450 2C19 Inhibitors; Cytochrome P450 2C8 Inhibitors; Cytochrome P450 2D6 Inhibitors; Cytochrome P450 3A4 Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-11
Route INTRAVENOUS
Dosage form INJECTION
Substance NICARDIPINE HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 858607
Why two NDCs? The FDA registers this code as 82432-103-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 82432-0103-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Dihydropyridine Calcium Channel Blocker class.

Pharmacologic class Dihydropyridine Calcium Channel Blocker
Drug family (ATC) Dihydropyridine derivatives
How it works Calcium Channel Antagonists, Cytochrome P450 2D6 Inhibitors, Cytochrome P450 2C19 Inhibitors, Cytochrome P450 3A4 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Nicardipine treats high blood pressure. The capsules are also used for chronic stable angina, which is chest pain brought on by effort. The IV form is used short term in a medical...
  • You take them by mouth, usually three times a day, and your prescriber adjusts the dose to your blood pressure. Doses shouldn't be raised more often than every 3 days. Food can low...
  • Common ones include ankle swelling, dizziness, headache, flushing, weakness and a pounding heartbeat. These come from the blood vessels widening. Call your doctor if your chest pai...
  • Tell me about everything you take. Nicardipine raises levels of cyclosporine and tacrolimus, and cimetidine raises nicardipine levels. Your doctor may check digoxin levels after yo...
📖 Read our full Nicardipine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
2
Nutrient depletion considerations

Nicardipine may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Nicardipine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
82432-0103-01 82432-103-01 Main listing 1 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS 2024-09-11 — Active
82432-0103-02 You're viewing this 10 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS 2025-11-17 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 10 vial, glass in 1 carton / 10 ml in 1 vial, glass.
What NDC number is used to bill for this package of NICARDIPINE HYDROCHLORIDE 25 mg/10mL Injection?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nicardipine Hydrochloride 2.5 mg/mL 00143-9542-10 Hikma 10 vials — AP FDA listed —
Nicardipine Hydrochloride 2.5 mg/mL 00143-9593-10 West-Ward 10 vials — AP FDA listed —
Nicardipine Hydrochloride 25 mg/10mL 00143-9689-10 Hikma 10 vials — AP FDA listed —
Nicardipine Hydrochloride 2.5 mg/mL 00517-0735-10 American 10 vials — AP FDA listed —
Nicardipine Hydrochloride 2.5 mg/mL 25021-0333-10 Sagent 10 vials — AP FDA listed —
Nicardipine Hydrochloride 2.5 mg/mL 42571-0394-89 Micro 10 vials — AP FDA listed —
Cardene Iv 2.5 mg/10mL 43066-0029-10 Baxter 10 vials — AP FDA listed —
Nicardipine Hydrochloride 25 mg/10mL 51662-1482-01 HF 10 ml — AP FDA listed —
Nicardipine Hydrochloride 25 mg/10mL 55150-0183-11 Eugia 10 vials — AP FDA listed —
Nicardipine Hydrochloride 25 mg/10mL 65219-0818-10 Fresenius 1 vial — AP FDA listed —
Nicardipine Hydrochloride 2.5 mg/mL 67184-0611-02 Qilu 10 vials — AP FDA listed —
Nicardipine hydrochloride 2.5 mg/mL 70756-0686-10 Lifestar 10 vials — AP FDA listed —
nicardipine hydrochloride 2.5 mg/mL 71288-0204-11 Meitheal 10 vials — AP FDA listed —
Nicardipine Hydrochloride 25 mg/10mL 72485-0116-10 Armas 10 vials — AP FDA listed —
Nicardipine Hydrochloride 2.5 mg/mL 72572-0470-10 Civica, 10 vials — AP FDA listed —
Nicardipine Hydrochloride 2.5 mg/mL 72819-0149-07 Archis 10 vials — AP FDA listed —
Nicardipine Hydrochloride 25 mg/10mLthis 82432-0103-02 Chengdu 10 vials — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerChengdu Shuode Pharmaceutical Co., Ltd
Application holderCHENGDU SHUODE PHARMACEUTICAL CO LTD
FDA applicationANDA217548 (ANDA)
Labeler code82432
First marketedSep 2024
Product typeHuman Prescription Drug
Portfolio4 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 73 words ▾

INDICATIONS AND USAGE Nicardipine hydrochloride injection is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible.

1 INDICATIONS AND USAGE

1.1Hypertension Nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.6) ].

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Individualize dosage based upon the severity of hypertension and response of the patient during dosing ( 2.1 ). Single dose vials must be diluted before use ( 2.2 ). When substituting for oral nicardipine therapy, use the intravenous infusion rate as follows ( 2.3 ): Oral Nicardipine Dose Equivalent Intravenous Infusion Rate 20 mg every 8 hours 0.5 mg/hr 30 mg every 8 hours 1.2 mg/hr 40 mg every 8 hours 2.2 mg/hr In a drug-free patient, initiate therapy at 5 mg/hr.

Increase the infusion rate by 2.5 mg/hr to a maximum of 15 mg/hr until desired blood pressure reduction is achieved. For a gradual blood pressure reduction the rate can be increased every 15 minutes, for a rapid reduction, every 5 minutes ( 2.4 ). If hypotension or tachycardia ensues, discontinue the infusion.

After stabilized, patient can be restarted at low doses such as 3 mg/hr to 5 mg/hr ( 2.5 ).

2 DOSAGE AND ADMINISTRATION

2.1General Information Individualize dosing based on the severity of hypertension and the response of the patient during dosing. Monitor blood pressure and heart rate both during and after the infusion to avoid tachycardia or too rapid or excessive reduction in either systolic or diastolic blood pressure. Administer Nicardipine Hydrochloride by slow continuous infusion by a central line or through a large peripheral vein.

Change the infusion site every 12 hours if administered via peripheral vein [see Intravenous Infusion Site (5.7) ] .

2.2Inspection and Preparation Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the solution if particulate matter, precipitate, or crystallization is present, or if the container appears damaged. Single Dose Vials Dilution Single dose vials must be diluted before infusion.

Each vial (25 mg) must be diluted with 240 mL of compatible intravenous fluid (see below), resulting in 250 mL of solution at a concentration of 0.1 mg/mL. Compatability Nicardipine hydrochloride injection has been found compatible and stable in polyvinyl chloride containers for 24 hours at controlled room temperature with: Dextrose (5%) Injection, USP Dextrose (5%) and Sodium Chloride (0.45%) Injection, USP Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP Dextrose (5%) with 40 mEq Potassium, USP Sodium Chloride (0.45%) Injection, USP Sodium Chloride (0.9%) Injection, USP Nicardipine hydrochloride is not compatible with Sodium Bicarbonate (5%) Injection, USP or Lactated Ringer’s Injection, USP.

Discard unused portion.

2.3Dosage as a Substitute for Oral Nicardipine Therapy The intravenous infusion rate required to produce an average plasma concentration equivalent to a given oral dose at steady state is shown in the following table: Oral Nicardipine Dose Equivalent Intravenous Infusion Rate 20 mg every 8 hours 0.5 mg/hr 30 mg every 8 hours 1.2 mg/hr 40 mg every 8 hours 2.2 mg/hr

2.4Dosage for Initiation of Therapy in a Drug-Free Patient The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment. Nicardipine hydrochloride injection is administered by slow continuous infusion at a concentration of 0.1 mg/mL. With constant infusion, blood pressure begins to fall within minutes.

It reaches about 50% of its ultimate decrease in about 45 minutes. When treating acute hypertensive episodes in patients with chronic hypertension, discontinuation of infusion is followed by a 50% offset of action in 30 minutes plus/minus 7 minutes but plasma levels of drug and gradually decreasing antihypertensive effects exist for many hours. Titration For a gradual reduction in blood pressure, initiate therapy at a rate of 5 mg/hr.

If desired blood pressure reduction is not achieved at this dose, increase the infusion rate by 2.5 mg/hr every 15 minutes up to a maximum of 15 mg/hr, until desired blood pressure reduction is achieved. For more rapi… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 55 words ▾

DOSAGE FORMS AND STRENGTHS 25 mg nicardipine hydrochloride in 10 mL injection (2.5 mg/mL) in a single dose vial

3 DOSAGE FORMS AND STRENGTHS Nicardipine hydrochloride injection, USP is a clear, yellow solution and is available in the following presentations: 25 mg nicardipine hydrochloride in 10 mL injection (2.5 mg/mL) in a single dose vial

⛔ Contraindications 52 words ▾

CONTRAINDICATIONS Do not use in patients with advanced aortic stenosis ( 4.1 ).

4 CONTRAINDICATIONS

4.1Advanced Aortic Stenosis Do not use nicardipine in patients with advanced aortic stenosis because of the afterload reduction effect of nicardipine. Reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.

⚠️ Warnings and Cautions ~2 min read ▾

WARNINGS AND PRECAUTIONS To reduce the possibility of venous thrombosis, phlebitis, and vascular impairment, do not use small veins, such as those on the dorsum of the hand or wrist. Avoid intraarterial administration or extravasation ( 5.7 ). To minimize the risk of peripheral venous irritation, change the site of infusion of nicardipine every 12 hours ( 5.7 ).

Nicardipine is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal. Withdraw beta-blockers gradually ( 5.8 ). Closely monitor response in patients with angina ( 5.3 ), congestive heart failure ( 5.4 ), impaired hepatic function ( 5.5 ), portal hypertension ( 5.5 ), and renal impairment ( 5.6 ) and pheochromocytoma ( 5.9 ).

5 WARNINGS AND PRECAUTIONS

5.1Excessive Pharmacologic Effects In administrating nicardipine, close monitoring of blood pressure and heart rate is required. Nicardipine may occasionally produce symptomatic hypotension or tachycardia. Avoid systemic hypotension when administering the drug to patients who have sustained an acute cerebral infarction or hemorrhage.

5.2Rapid Decreases in Blood Pressure No clinical events have been reported suggestive of a too rapid decrease in blood pressure with nicardipine. However, as with any antihypertensive agent, blood pressure lowering should be accomplished over as long a time as is compatible with the patient's clinical status.

5.3Use in Patients with Angina Increases in frequency, duration, or severity of angina have been seen in chronic oral therapy with nicardipine capsules. Induction or exacerbation of angina has been seen in less than 1% of coronary artery disease patients treated with nicardipine. The mechanism of this effect has not been established.

5.4Use in Patients with Congestive Heart Failure Nicardipine reduced afterload without impairing myocardial contractility in preliminary hemodynamic studies of CHF patients. However, in vitro and in some patients, a negative inotropic effect has been observed. Therefore, monitor vital signs carefully when using nicardipine, particularly in combination with a beta-blocker, in patients with CHF or significant left ventricular dysfunction.

5.5Use in Patients with Impaired Hepatic Function Since nicardipine is metabolized in the liver, consider lower dosages and closely monitor response. Nicardipine administered intravenously increased hepatic venous pressure gradient by 4 mmHg in cirrhotic patients at high doses (5 mg/20 min) in one study. Use caution in patients with portal hypertension.

5.6Use in Patients with Impaired Renal Function When nicardipine was given to mild-to-moderate hypertensive patients with moderate renal impairment, a significantly lower systemic clearance and higher AUC was observed. These results are consistent with those seen after oral administration of nicardipine. Careful dose titration is advised when treating patients with more than mild renal impairment.

5.7Intravenous Infusion Site To reduce the possibility of venous thrombosis, phlebitis, local irritation, swelling, extravasation, and the rare occurrence of vascular impairment, administer drug through large peripheral veins or central veins rather than arteries or small peripheral veins, such as those on the dorsum of the hand or wrist. To minimize the risk of peripheral venous irritation, consider changing the site of the drug infusion every 12 hours.

5.8Beta-Blocker Withdrawal Nicardipine is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal. Withdraw beta-blockers gradually.

5.9Use in Patients with Pheochromocytoma Only limited clinical experience exists in use of nicardipine for patients with hypertension from pheochromocytoma.

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS Most common adverse reactions are headache (13%), hypotension (5%), tachycardia (4%) and nausea/vomiting (4%). To report SUSPECTED ADVERSE REACTIONS, contact Chengdu Shuode Pharmaceutical Co., Ltd at +86-286-523-8888 or the FDA at 1-800-FDA- 1088 or www.fda.gov/medwatch.

6 ADVERSE REACTIONS

6.1Adverse Reactions Observed in Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Two hundred forty-four patients participated in two multicenter, double-blind, placebo-controlled trials of nicardipine. Adverse experiences were generally not serious and most were expected consequences of vasodilation.

Adverse reactions occasionally required dosage adjustment. Therapy was discontinued in approximately 12% of patients, mainly due to hypotension, headache, and tachycardia. Adverse reactions that occurred more often on nicardipine than on placebo by at least 2% were headache (13%) and nausea/vomiting (4%).

The following adverse reactions have been reported in clinical trials or in the literature during the use of intravenously administered nicardipine. Body as a Whole: fever, neck pain Cardiovascular: angina pectoris, atrioventricular block, ST segment depression, inverted T wave, deep-vein thrombophlebitis Digestive: dyspepsia Hemic and Lymphatic: thrombocytopenia Metabolic and Nutritional: hypophosphatemia, peripheral edema Nervous: confusion, hypertonia Respiratory: respiratory disorder Special Senses: conjunctivitis, ear disorder, tinnitus Urogenital: urinary frequency Sinus node dysfunction and myocardial infarction, which may be due to disease progression, have been seen in patients on chronic therapy with orally administered nicardipine.

🔄 Drug Interactions ~1 min read ▾

DRUG INTERACTIONS Cimetidine increases nicardipine plasma levels ( 7.3 ). Nicardipine may increase cyclosporine and tacrolimus plasma levels. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended when co-administering nicardipine. ( 7.5 , 7.6 ).

7 DRUG INTERACTIONS

7.1Antihypertensive Agents Since nicardipine hydrochloride injection may be administered to patients already being treated with other medications, including other antihypertensive agents, careful monitoring of these patients is necessary to detect and to treat promptly any undesired effects from concomitant administration.

7.2Beta-Blockers In most patients, nicardipine hydrochloride injection can safely be used concomitantly with beta-blockers. However, monitor response carefully when combining nicardipine hydrochloride injection with a beta-blocker in the treatment of congestive heart failure patients [see Warnings and Precautions (5.4) ] .

7.3Cimetidine Cimetidine has been shown to increase nicardipine plasma concentrations with oral nicardipine administration. Carefully monitor patients receiving the two drugs concomitantly. Data with other histamine-2 antagonists are not available.

7.4Digoxin Studies have shown that oral nicardipine usually does not alter digoxin plasma concentrations.

7.5Cyclosporine Concomitant administration of oral or intravenous nicardipine and cyclosporine results in elevated plasma cyclosporine levels through nicardipine inhibition of hepatic microsomal enzymes, including CYP3A4. Monitor closely plasma concentrations of cyclosporine during nicardipine hydrochloride injection administration, and adjust the dose of cyclosporine accordingly.

7.6Tacrolimus Concomitant administration of intravenous nicardipine and tacrolimus may result in elevated plasma tacrolimus levels through nicardipine inhibition of hepatic microsomal enzymes, including CYP3A4. Closely monitor plasma concentrations of tacrolimus during nicardipine administration, and adjust the dose of tacrolimus accordingly.

7.7In Vitro Interaction The plasma protein binding of nicardipine was not altered when therapeutic concentrations of furosemide, propranolol, dipyridamole, warfarin, quinidine, or naproxen were added to human plasma in vitro.

👥 Use in Specific Populations ~3 min read ▾

USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1 ). Nursing Mothers: It is recommended that women who wish to breastfeed should not be given this drug ( 8.3 ). Safety and efficacy in patients under the age of 18 have not been established ( 8.4 ). Revised: 11/2025

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies of nicardipine use in pregnant women. There are limited human data in pregnant women with pre-eclampsia and preterm labor.

In animal reproduction and developmental toxicity studies, evidence of fetal harm was observed. Therefore use nicardipine during pregnancy only if the potential benefit justifies the potential risk to the fetus. In reproduction studies conducted in rats and rabbits, increased embryolethality occurred when nicardipine was administered intravenously at doses equivalent to human intravenous doses of 1.6 (rats) and 0.32 mg/kg/day (rabbits).

Increased embryolethality was also observed when nicardipine was administered orally to pregnant rabbits at a dose equivalent to a human oral dose of about 48 mg/kg/day (a dose 24 times the maximum recommended human oral dose and one associated with marked maternal body weight gain suppression). At a lower oral dose, equivalent to a human dose of about 32 mg/kg/day (16 times the maximum recommended human oral dose), in a different strain of rabbit, there were no adverse effects on the fetus, though there was increased maternal mortality.

There was no evidence of embryolethality or teratogenicity when pregnant rats were administered nicardipine orally at a dose equivalent to a human oral dose of about 16 mg/kg/day (8 times the MRHD); however, dystocia, reduced birth weight, reduced neonatal survival and reduced neonatal weight gain were reported [see Nonclinical Toxicology (13.3) ] .

8.3Nursing Mothers Nicardipine is minimally excreted into human milk. Among 18 infants exposed to nicardipine through breast milk in the postpartum period, calculated daily infant dose was less than 0.3 mcg and there were no adverse events observed. It is recommended that women who wish to breastfeed should not be given this drug.

In a study of 11 women who received oral nicardipine 4 days to 14 days postpartum, 4 women received immediate-release nicardipine 40 to 80 mg daily, 6 women received sustained-release nicardipine 100 mg to 150 mg daily, and one woman received intravenous nicardipine 120 mg daily. The peak milk concentration was 7.3 mcg/L (range 1.9 to 18.8), and the mean milk concentration was 4.4 mcg/L (range 1.3 to 13.8). Infants received an average of 0.073% of the weight-adjusted maternal oral dose and 0.14% of the weight-adjusted maternal intravenous dose.

In another study of seven women who received intravenous nicardipine for an average of 1.9 days in the immediate postpartum period as therapy for pre-eclampsia, 34 milk samples were obtained at unspecified times and nicardipine was undetectable (less than 5 mcg/L) in 82% of the samples. Four women who received 1 to 6.5 mg/hour of nicardipine had 6 milk samples with detectable nicardipine levels (range 5.1 to 18.5 mcg/L). The highest concentration of 18.5 mcg/L was found in a woman who received 5.5 mg/hour of nicardipine.

The estimated maximum dose in a breastfed infant was less than 0.3 mcg daily or 0.015% to 0.004% of the therapeutic dose in a 1 kg infant.

8.4Pediatric Use Safety and efficacy in patients under the age of 18 have not been established.

8.5Geriatric Use The steady-state pharmacokinetics of nicardipine are similar in elderly hypertensive patients (greater than 65 years) and young healthy adults. Clinical studies of nicardipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selecti… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 171 words ▾

10 OVERDOSAGE Several overdosages with orally administered nicardipine have been reported. One adult patient allegedly ingested 600 mg of nicardipine immediate release capsules, and another patient, 2160 mg of the sustained release formulation of nicardipine. Symptoms included marked hypotension, bradycardia, palpitations, flushing, drowsiness, confusion and slurred speech.

All symptoms resolved without sequelae. An overdosage occurred in a one-year-old child who ingested half of the powder in a 30 mg nicardipine standard capsule. The child remained asymptomatic.

Based on results obtained in laboratory animals, lethal overdose may cause systemic hypotension, bradycardia (following initial tachycardia) and progressive atrioventricular conduction block. Reversible hepatic function abnormalities and sporadic focal hepatic necrosis were noted in some animal species receiving very large doses of nicardipine. For treatment of overdosage, standard measures including monitoring of cardiac and respiratory functions should be implemented.

The patient should be positioned to avoid cerebral anoxia. Frequent blood pressure determinations are essential. Vasopressors are clinically indicated for patients exhibiting profound hypotension.

Intravenous calcium gluconate may help reverse the effects of calcium entry blockade.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Nicardipine inhibits the transmembrane influx of calcium ions into cardiac muscle and smooth muscle without changing serum calcium concentrations. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. The effects of nicardipine are more selective to vascular smooth muscle than cardiac muscle.

In animal models, nicardipine produced relaxation of coronary vascular smooth muscle at drug levels which cause little or no negative inotropic effect.

12.2Pharmacodynamics Hemodynamics Nicardipine produces significant decreases in systemic vascular resistance. In a study of intra-arterially administered nicardipine, the degree of vasodilation and the resultant decrease in blood pressure were more prominent in hypertensive patients than in normotensive volunteers. Administration of nicardipine to normotensive volunteers at dosages of 0.25 to 3 mg/hr for eight hours produced changes of less than 5 mmHg in systolic blood pressure and less than 3 mmHg in diastolic blood pressure.

An increase in heart rate is a normal response to vasodilation and decrease in blood pressure; in some patients these increases in heart rate may be pronounced. In placebo-controlled trials, the mean increases in heart rate were 7 ± 1 bpm in postoperative patients and 8 ± 1 bpm in patients with severe hypertension at the end of the maintenance period. Hemodynamic studies following intravenous dosing in patients with coronary artery disease and normal or moderately abnormal left ventricular function have shown significant increases in ejection fraction and cardiac output with no significant change, or a small decrease, in left ventricular end-diastolic pressure (LVEDP).

There is evidence that nicardipine increases blood flow. Coronary dilatation induced by nicardipine improves perfusion and aerobic metabolism in areas with chronic ischemia, resulting in reduced lactate production and augmented oxygen consumption. In patients with coronary artery disease, nicardipine, administered after beta-blockade, significantly improved systolic and diastolic left ventricular function.

In congestive heart failure patients with impaired left ventricular function, nicardipine increased cardiac output both at rest and during exercise. Decreases in left ventricular end-diastolic pressure were also observed. However, in some patients with severe left ventricular dysfunction, it may have a negative inotropic effect and could lead to worsened failure. “Coronary steal” has not been observed during treatment with nicardipine (Coronary steal is the detrimental redistribution of coronary blood flow in patients with coronary artery disease from underperfused areas toward better perfused areas.) Nicardipine has been shown to improve systolic shortening in both normal and hypokinetic segments of myocardial muscle.

Radionuclide angiography has confirmed that wall motion remained improved during increased oxygen demand. (Occasional patients have developed increased angina upon receiving nicardipine capsules. Whether this represents coronary steal in these patients, or is the result of increased heart rate and decreased diastolic pressure, is not clear.) In patients with coronary artery disease, nicardipine improves left ventricular diastolic distensibility during the early filling phase, probably due to a faster rate of myocardial relaxation in previously underperfused areas.

There is little or no effect on normal myocardium, suggesting the improvement is mainly by indirect mechanisms such as afterload reduction and reduced ischemia. Nicardipine has no negative effect on myocardial relaxation at therapeutic doses. The clinical benefits of these properties have not yet been demonstrated.

Electrophysiologic Effects In general, no detrimental effects on the cardiac conduction system have been seen with nicardipine. During ac… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 108 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Nicardipine Hydrochloride Injection, USP is a clear, yellow solution and is available in packages as follows: NDC Strength Packaged 82432-103-01 82432-103-02 25 mg/10 mL Single Dose Vial (2.5 mg/mL) 1 vial of 10 mL 10 vials of 10 mL

16.2Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Freezing does not adversely affect the product, but exposure to elevated temperatures should be avoided. Protect from light. Store vials in carton until used. Manufactured by: Chengdu Shuode Pharmaceutical Co., Ltd No. 9 Lekang Road, Shuangliu District, Chengdu, Sichuan 610200, China (CHN) Revised: 11/2025

📋 Description 178 words ▾

11 DESCRIPTION Nicardipine hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride injection, USP for intravenous administration contains 2.5 mg/mL of nicardipine hydrochloride. Nicardipine hydrochloride is a dihydropyridine derivative with IUPAC (International Union of Pure and Applied Chemistry) chemical name (±)-2-(benzyl-methyl amino) ethyl methyl 1,4-dihydro-2, 6-dimethyl-4- (m-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride and has the following structure: Nicardipine hydrochloride is a pale yellow to yellow, odorless, powder or crystalline powder that has a melting point range of 179- 188 o C (Melt with decomposition).

It is soluble in methanol and glacial acetic acid, sparingly soluble in ethanol and chloroform, practically insoluble in ethyl ether and water. It has a molecular weight of 515.99. Nicardipine hydrochloride injection, USP is available as a sterile, non-pyrogenic, clear, yellow solution in 10 mL vials for intravenous infusion after dilution.

Each mL contains 2.5 mg nicardipine hydrochloride, 0.305 mg benzoic acid, USP and 7.5 mg sodium chloride, USP, in Water for Injection, USP. Sodium hydroxide, NF, (q.s.) may have been added to adjust pH to 3.2 to 4.2. image description

🔬 Clinical Studies 184 words ▾

14 CLINICAL STUDIES Effects in Hypertension In patients with mild-to-moderate chronic stable essential hypertension, nicardipine hydrochloride injection (0.5 to 4 mg/hr) produced dose-dependent decreases in blood pressure, although only the decreases at 4 mg/hr were statistically different from placebo. At the end of a 48-hour infusion at 4 mg/hr, the decreases were 26 mmHg (17%) in systolic blood pressure and 21 mmHg (20%) in diastolic blood pressure. In other settings (e.g., patients with severe or postoperative hypertension), nicardipine hydrochloride injection (5 to 15 mg/hr) produced dose-dependent decreases in blood pressure.

Higher infusion rates produced therapeutic responses more rapidly. The mean time to therapeutic response for severe hypertension, defined as diastolic blood pressure less than or equal to 95 mmHg or greater or equal to 25 mmHg decrease and systolic blood pressure less than or equal to 160 mmHg, was 77 ± 5 minutes. The average maintenance dose was 8.0 mg/hr.

The mean time to therapeutic response for postoperative hypertension, defined as greater than or equal to 15% reduction in diastolic or systolic blood pressure, was 12 minutes. The average maintenance dose was 3 mg/hr.

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Rats treated with nicardipine in the diet (at concentrations calculated to provide daily dosage levels of 5, 15, or 45 mg/kg/day) for two years showed a dose-dependent increase in thyroid hyperplasia and neoplasia (follicular adenoma/carcinoma). One-month and three-month studies in the rat have suggested that these results are linked to a nicardipine-induced reduction in plasma thyroxine (T4) levels with a consequent increase in plasma levels of thyroid stimulating hormone (TSH).

Chronic elevation of TSH is known to cause hyperstimulation of the thyroid. In rats on an iodine deficient diet, nicardipine administration for one month was associated with thyroid hyperplasia that was prevented by T4 supplementation. Mice treated with nicardipine in the diet (at concentrations calculated to provide daily dosage levels of up to 100 mg/kg/day) for up to 18 months showed no evidence of neoplasia of any tissue and no evidence of thyroid changes.

There was no evidence of thyroid pathology in dogs treated with up to 25 mg nicardipine/kg/day for one year and no evidence of effects of nicardipine on thyroid function (plasma T4 and TSH) in man. There was no evidence of a mutagenic potential of nicardipine in a battery of genotoxicity tests conducted on microbial indicator organisms, in micronucleus tests in mice and hamsters, or in a sister chromatid exchange study in hamsters. No impairment of fertility was seen in male or female rats administered nicardipine at oral doses as high as 100 mg/kg/day (human equivalent dose about 16 mg/kg/day, 8 times the maximum recommended human oral dose).

13.3Reproductive and Developmental Toxicology Embryolethality, but no teratogenicity, was seen at intravenous doses of 10 mg nicardipine/kg/day in rats and 1 mg/kg/day in rabbits. These doses in the rat and rabbit are equivalent to human intravenous doses of about 1.6 and 0.32 mg/kg/day, respectively. (The total daily human dose delivered by a continuous intravenous infusion ranges from 1.2 to 6 mg/kg/day, depending on duration at different infusion rates ranging from 3 to 15 mg/hr as individual patients are titrated for optimal results.) Nicardipine was also embryocidal when administered orally to pregnant Japanese White rabbits, during organogenesis, at 150 mg/kg/day (a dose associated with marked body weight gain suppression in the treated doe), but not at 50 mg/kg/day (human equivalent dose about 16 mg/kg/day or about 8 times the maximum recommended human oral dose).

No adverse effects on the fetus were observed when New Zealand albino rabbits were treated orally, during organogenesis, with up to 100 mg/kg/day (a dose associated with significant mortality in the treated doe). In pregnant rats administered nicardipine orally at doses of up to 100 mg/kg/day (human equivalent dose about 16 mg/kg/day) there was no evidence of embryolethality or teratogenicity. However, dystocia, reduced birth weight, reduced neonatal survival and reduced neonatal weight gain were noted.

📄 Package Label / Principal Display Panel ~2 min read ▾

Package label - Principal Display Panel - Vial Label Principal Display Panel Rx only NDC 82432-103-01 niCARdipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL) Warning: Must be diluted before infusion Discard Unused Portion For Intravenous Use Only. Usual Dosage: See package insert. 10 mL Single Dose Vial Each 10 mL vial contains 25 mg nicardipine hydrochloride, 3.05 mg benzoic acid, USP and 75 mg sodium chloride, USP, in Water for Injection, USP.

Sodium hydroxide (q.s.) may have been added to adjust pH to 3.2 - 4.2. Protect from light. Retain in carton.

Store at 20o to 25℃ (68° to 77°F) [See USP Controlled Room Temperature]. Chengdu Shuode Pharmaceutical Co., Ltd Lot No.: Exp. Date: Package label - Principal Display Panel - Carton Label - 1 vial/carton Principal Display Panel Rx only NDC 82432-103-01 niCARdipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL) Warning: Must be diluted before infusion For Intravenous Use Only.

Discard Unused Portion 1 × 10 mL Single Dose Vial Each 10 mL vial contains 25 mg nicardipine hydrochloride, 3.05 mg benzoic acid, USP and 75 mg sodium chloride, USP, in Water for Injection, USP. Sodium hydroxide (q.s.) may have been added to adjust pH to 3.2 - 4.2. Usual Dosage: See package insert.

DO NOT USE and DISCARD the vial if particulate matter, precipitation, or crystallization is present or if the container appears damaged. Store at 20° to 25℃ (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Store in a carton until ready for use. Manufactured by: Chengdu Shuode Pharmaceutical Co., Ltd No. 9 Lekang Road, Shuangliu District, Chengdu, Sichuan 610200, China (CHN) Lot No.: Exp.

Date: Package label - Principal Display Panel - Carton Label - 10 vials/carton Principal Display Panel Rx only NDC 82432-103-02 niCARdipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL) WARNING: MUST BE DILUTED BEFORE INFUSION For Intravenous use ONLY Discard Unused Portion 10 × 10 mL Single Dose Vials Each 10 mL vial contains 25 mg nicardipine hydrochloride, 3.05 mg benzoic acid, USP and 75 mg sodium chloride, USP, in Water for Injection, USP. Sodium hydroxide (q.s.) may have been added to adjust pH to 3.2 - 4.2.

Usual Dosage: See package insert. DO NOT USE and DISCARD the vial if particulate matter, precipitation, or crystallization is present or if the container appears damaged. Store at 20° to 25℃ (68° to 77°F) [See USP Controlled Room Temperature].

Protect from light. Store in a carton until ready for use. Manufactured by: Chengdu Shuode Pharmaceutical Co., Ltd No.

9 Lekang Road, Shuangliu District, Chengdu, Sichuan 610200, China (CHN) Lot No.: Exp. Date: image description image description image description

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Does this product come in other package sizes?
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← 82432-0102-02 · Chengdu 82432-0104-02 · Chengdu →
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