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Nicardipine hydrochloride 2.5 mg/mL Injection — NDC 70756-0686-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nicardipine hydrochloride 2.5 mg/mL Injection — NDC 70756-686-10 (Billing 70756-0686-10)

by Lifestar Pharma LLC · 10 VIAL in 1 CARTON / 10 mL in 1 VIAL

This is a package of Nicardipine hydrochloride 2.5 mg/mL Injection from Lifestar Pharma LLC, marketed since Feb 2026 and currently FDA-listed. It is this product's only package size.

NDC 70756-0686-10
🏷️ FDA NDC (as labeled) 70756-686-10 billing pads the product segment with a zero
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) 70756-686-10
Product NDC 70756-686
11-digit billing NDC 70756068610
NCPDP billing unit ML — per mL (volume)
RxCUI 858607
UNII K5BC5011K3
UPC 0370756686866
Application # ANDA090671
SPL Set ID b0e2bed3-f928-43ab-a05c-275bedc9856f
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 2026-02-24
Route INTRAVENOUS
Dosage form INJECTION
Substance NICARDIPINE HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 064353
GCN 13634
HICL code 000183
Ingredient (HICL) Nicardipine Hcl
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A9
Therapeutic class — intermediate (HIC2) Calcium Antagonists
HIC3 code A9A
Therapeutic class — specific (HIC3) Calcium Channel Blocking Agents
AHFS code 24:28.08.00
AHFS class Dihydropyridines
FDB label name NICARDIPINE 25 MG/10 ML VIAL
FDB brand name Nicardipine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 064353
  • GCN: 13634
  • HICL (First Databank): 000183
  • AHFS class code: 24:28.08.00
  • RxCUI (RxNorm): 858607
Why two NDCs? The FDA registers this code as 70756-686-10 — 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 → 70756-0686-10. 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

Label name NICARDIPINE 25 MG/10 ML VIAL Ingredient Nicardipine Hcl
📗 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.
Medicare Part B allowsASP · J2404 $0.070 / J2404 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)70756-686-10
11-digit billing NDC70756-0686-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2404
DescriptorINJECTION, NICARDIPINE, 0.1 MG
Billing units / pkg25 units
How the units are derivedThis package is 10 ML; the HCPCS unit is 0.1 MG, so one package = 25 billing units.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70756-0686-10 You're viewing this Main listing 10 VIAL in 1 CARTON / 10 mL in 1 VIAL 2026-02-24 — Active

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/mLthis 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/10mL 82432-0103-01 Chengdu 1 vial — 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

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerLifestar Pharma LLC
Application holderMANKIND PHARMA LTD
FDA applicationANDA090671 (ANDA)
Labeler code70756
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio155 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 78 words ▾

1 INDICATIONS AND USAGE Nicardipine hydrochloride injection, USP is a calcium channel blocker indicated for the short-term treatment of hypertension in adults when oral therapy is not feasible. (1.1)

1.1Hypertension Nicardipine hydrochloride injection, USP is indicated in adults for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.1)] .

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For Intravenous Use. (2.1) Dilution is required. (2.3) When substituting for oral nicardipine therapy, use the intravenous infusion rate from the table below (2.1): Oral Nicardipine hydrochloride Dose Equivalent I.V.

Infusion Rate (0.1 mg/mL) 20 mg q8h 0.5 mg/hr = 5 mL/hr 30 mg q8h 1.2 mg/hr = 12 mL/hr 40 mg q8h 2.2 mg/hr = 22 mL/hr In a patient not receiving oral nicardipine, initiate therapy at 5 mg/hr. Increase the infusion rate by 2.5 mg/hr every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 15 mg/hr until desired blood pressure reduction is achieved. (2.1) Conversion Table (mg/hr) Equivalent I.V.

Infusion Rate (0.1 mg/mL) 5 mg/hr 50 mL/hr 2.5 mg/hr 25 mL/hr 15 mg/hr 150 mL/hr If unacceptable hypotension or tachycardia occurs, discontinue the infusion. When blood pressure and heart rate stabilize, restart the infusion at low doses such as 3-5 mg/hr. (2.2)

2.1Recommended Dosing Nicardipine hydrochloride injection, USP is intended for intravenous use. Vial must be diluted to 0.1 mg/ml before use [see Dosage and Administration (2.3)]. Titrate dose to achieve the desired blood pressure reduction.

Individualize dosage depending on the blood pressure to be obtained and the response of the patient. Dosage 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 hydrochloride Dose Equivalent I.V. Infusion Rate (0.1 mg/mL) 20 mg q8h 0.5 mg/hr = 5 mL/hr 30 mg q8h 1.2 mg/hr = 12 mL/hr 40 mg q8h 2.2 mg/hr = 22 mL/hr Dosage for Initiation of Therapy in a Patient Not Receiving Oral Nicardipine Initiate therapy at 50 mL/hr (5 mg/hr).

If desired blood pressure reduction is not achieved at this dose, the infusion rate may be increased by 25 mL/hr (2.5 mg/hr) every 5 minutes (for rapid titration) to 15 minutes (for gradual titration) up to a maximum of 150 mL/hr (15 mg/hr), until desired blood pressure reduction is achieved. Following achievement of the blood pressure goal utilizing rapid titration, decrease the infusion rate to 30 mL/hr (3 mg/hr). Drug Discontinuation and Transition to an Oral Antihypertensive Agent Discontinuation of infusion is followed by a 50% offset of action in about 30 minutes.

If treatment includes transfer to an oral antihypertensive agent other than oral nicardipine, initiate therapy upon discontinuation of nicardipine hydrochloride injection. If oral nicardipine is to be used, administer the first dose 1 hour prior to discontinuation of the infusion. Special Populations Titrate nicardipine hydrochloride injection slowly in patients with heart failure or impaired hepatic or renal function [see Warnings and Precautions (5.2, 5.3 and 5.4)]

2.2Monitoring The time course of blood pressure decrease is dependent on the initial rate of infusion and the frequency of dosage adjustment. With constant infusion, blood pressure begins to fall within minutes. It reaches about 50% of its ultimate decrease in about 45 minutes.

Monitor blood pressure and heart rate continually during infusion and avoid too rapid or excessive blood pressure drop during treatment. If there is concern of impending hypotension or tachycardia, the infusion should be discontinued. Then, when blood pressure has stabilized, infusion of nicardipine hydrochloride injection may be restarted at low doses such as 30-50 mL/hr (3-5 mg/hr) and adjusted to maintain desired blood pressure.

2.3Instructions for Administration Administer nicardipine hydrochloride injection by a central line or through a large peripheral vein. Change the infusion site every 12 hours if administered via peripheral vein [see Warnings and Precautions (5.5)] . Preparation for Administration Vials must be diluted before infusion.

Inspection As with all parenteral drugs, nicardipine hydrochloride injection. should be inspected visually for particulate m… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 48 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 25 mg of nicardipine hydrochloride in 10 mL (2.5 mg/mL) as a clear, yellow solution in an vial for dilution Nicardipine hydrochloride injection is supplied in a vial containing 25 mg of nicardipine hydrochloride in 10 mL (2.5 mg/mL) for intravenous infusion

⛔ Contraindications 56 words ▾

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

4.1Advanced Aortic Stenosis Nicardipine hydrochloride injection is contraindicated in patients with advanced aortic stenosis because part of the effect of nicardipine hydrochloride injection is secondary to reduced afterload. Reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Closely monitor response in patients with angina, heart failure, impaired hepatic function, or renal impairment. (5.1, 5.2, 5.3, 5.4) 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. Exercise extreme care to avoid intra-arterial administration or extravasation.

(5.5) To minimize the risk of peripheral venous irritation, change the site of infusion of nicardipine hydrochloride injection every 12 hours. (5.5)

5.1Exacerbation of Angina Increases in frequency, duration, or severity of angina have been seen in chronic therapy with oral nicardipine. Induction or exacerbation of angina has been seen in less than 1% of coronary artery disease patients treated with nicardipine hydrochloride injection. The mechanism of this effect has not been established.

5.2Exacerbation of Heart Failure Titrate slowly when using nicardipine hydrochloride injection, particularly in combination with a beta-blocker, in patients with heart failure or significant left ventricular dysfunction because of possible negative inotropic effects.

5.3Increased effect with Impaired Hepatic Function Since nicardipine is metabolized in the liver, consider lower dosages and closely monitor responses in patients with impaired liver function or reduced hepatic blood flow.

5.4Prolonged effect with Impaired Renal Function When nicardipine hydrochloride injection was given to mild to moderate hypertensive patients with moderate renal impairment, a significantly lower systemic clearance and higher area under the curve (AUC) was observed. These results are consistent with those seen after oral administration of nicardipine. Titrate gradually in patients with renal impairment.

5.5Local Irritation To reduce the possibility of venous thrombosis, phlebitis, local irritation, swelling, extravasation, and the 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, change the site of the drug infusion every 12 hours.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions are headache (15%), hypotension (6%), tachycardia (4%) and nausea/vomiting (5%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience 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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Two hundred forty-four patients participated in two multicenter, double-blind, placebo-controlled trials of nicardipine hydrochloride injection.

Adverse experiences were generally not serious and most were expected consequences of vasodilation. Adverse experiences occasionally required dosage adjustment. Therapy was discontinued in approximately 12% of patients, mainly due to hypotension, headache, and tachycardia.

The table below shows percentage of patients with adverse events where the rate is >3% more common on nicardipine hydrochloride injection than placebo. Adverse Event Nicardipine hydrochloride (N=144) Placebo (N=100) Body as a Whole Headache, n (%) 21 (15) 2 (2) Cardiovascular Hypotension, n (%) 8 (6) 1 (1) Tachycardia, n (%) 5 (4) 0 Digestive Nausea/vomiting, n (%) 7 (5) 1 (1) Other adverse events have been reported in clinical trials or in the literature in association with 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.

6.2Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure. The following adverse reaction has been identified during post-approval use of nicardipine hydrochloride injection: decreased oxygen saturation (possible pulmonary shunting).

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Cimetidine increases oral nicardipine plasma levels. (7.2) Oral or intravenous nicardipine may increase cyclosporine and tacrolimus plasma levels. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended when co-administering nicardipine hydrochloride injection (7.3, 7.4)

7.1Beta-Blockers In most patients, nicardipine hydrochloride injection can safely be used concomitantly with beta-blockers. However, titrate slowly when using nicardipine hydrochloride injection in combination with a beta-blocker in heart failure patients [see Warnings and Precautions (5.2)] .

7.2Cimetidine Cimetidine has been shown to increase nicardipine plasma concentrations with oral nicardipine administration. Frequently monitor response in patients receiving both drugs. Data with other histamine-2 antagonists are not available.

7.3Cyclosporine Concomitant administration of oral or intravenous nicardipine and cyclosporine results in elevated plasma cyclosporine levels through nicardipine inhibition of hepatic microsomal enzymes, including CYP3A4. Closely monitor plasma concentrations of cyclosporine during nicardipine hydrochloride injection administration, and reduce the dose of cyclosporine accordingly.

7.4Tacrolimus 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 hydrochloride injection administration, and adjust the dose of tacrolimus accordingly.

7.5In 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 ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data may cause embryofetal harm. (8.1)

8.1Pregnancy Risk Summary Available data from published literature (clinical trials and case series) over decades of use of intravenous nicardipine during pregnancy have not identified a drug-associated risk of major birth defects or miscarriage. However, nicardipine is predominantly used in pregnancy after 20 gestational weeks. Use of nicardipine in women with preeclampsia or pre-term labor is associated with maternal and fetal/neonatal adverse events.

Maternal adverse events included pulmonary edema, dyspnea, hypoxia, hypotension, reflex tachycardia, postpartum hemorrhage, tocolysis, headache, nausea, dizziness, flushing, and phlebitis at site of injection. Fetal/neonatal adverse events included transient fetal heart rate decelerations, hypotension and acidosis (pH<7.25) (see Clinical Considerations) . In animal reproductive and developmental toxicity studies in which nicardipine was administered intravenously to pregnant rats and rabbits during organogenesis, increased embryolethality, but no teratogenicity occurred at a dose 0.27 times and 0.05 times the maximum recommended human dose (MRHD) in rats and rabbits, respectively.

No embryotoxicity occurred in offspring of pregnant rats administered oral doses of nicardipine 8 times the oral MRHD, but did occur in offspring of pregnant rabbits with oral doses at 24 times the oral MRHD (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and miscarriage is 15% to 20% of clinically recognized pregnancies. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and stillbirth.

Pregnant women with hypertension should be carefully monitored and managed accordingly. Maternal Adverse Reactions Hypotension, reflex tachycardia, postpartum hemorrhage, tocolysis, headache, nausea, dizziness, and flushing have been reported in pregnant women who were treated with intravenous nicardipine for hypertension during pregnancy. Adverse events in women treated with intravenous nicardipine during pre-term labor include pulmonary edema, dyspnea, hypoxia, hypotension, tachycardia, headache, and phlebitis at site of injection.

Manage the patient accordingly. Fetal/Neonatal Adverse Reactions Nicardipine crosses the placenta. Transient fetal heart rate decelerations have been reported.

Hypotension and acidosis (pH<7.25) have also been reported in neonates. The relationship to the use of nicardipine is not clear. If fetal heart rate decelerations, or neonatal hypotension or acidosis occur, manage accordingly.

Data Animal Data In embryofetal toxicity studies, no embryotoxicity or teratogenicity was seen when nicardipine was administered intravenously to pregnant rats and rabbits during organogenesis at doses up to 0.14 times the MRHD based on body surface area (mg/m 2 ) (5 mg/kg/day in rats) and 0.03 times the MRHD based on body surface area (mg/m 2 ) (0.5 mg/kg/day in rabbits). Embryolethality, but no teratogenicity was seen at 0.27 times the MRHD based on body surface area (mg/m 2 ) (10 mg/kg/day) in rats and at 0.05 times the MRHD based on body surface are (mg/m 2 ) (1 mg/kg/day) in rabbits.

In other animal studies, pregnant Japanese White rabbits received oral nicardipine during organogenesis, at doses 8 and 24 times the oral MRHD based on body surface area (mg/m 2 ) (50 and 150 mg/kg/day). Embryolethality occurred at the high dose along with signs of maternal toxicity (m… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 149 words ▾

10 OVERDOSAGE Several overdosages with orally administered nicardipine have been reported. One adult patient allegedly ingested 600 mg of immediate-release oral nicardipine, 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, implement standard measures including monitoring of cardiac and respiratory functions.

Position the patient so as to avoid cerebral anoxia. Use vasopressors for patients exhibiting profound hypotension.

🧬 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 hydrochloride injection produces significant decreases in systemic vascular resistance. In a study of intra-arterially administered nicardipine hydrochloride injection the degree of vasodilation and the resultant decrease in blood pressure were more prominent in hypertensive patients than in normotensive volunteers. Administration of nicardipine hydrochloride injection to normotensive volunteers at dosages of 0.25 to 3 mg/hr for eight hours produced changes of <5 mmHg in systolic blood pressure and <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 hydrochloride increases blood flow. Coronary dilatation induced by nicardipine hydrochloride injection 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 hydrochloride injection, administered after beta-blockade, significantly improved systolic and diastolic left ventricular function.

In congestive heart failure patients with impaired left ventricular function, nicardipine hydrochloride injection 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 [see Warnings and Precautions (5.2)] . "Coronary steal" has not been observed during treatment with nicardipine hydrochloride injection (Coronary steal is the detrimental redistribution of coronary blood flow in patients with coronary artery disease from underperfused areas toward better perfused areas.) Nicardipine hydrochloride injection 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 oral nicardipine. 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 hydrochloride injection 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 hydrochloride injection has no negat… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 119 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Nicardipine hydrochloride injection, USP 25 mg/10 mL (2.5 mg/mL) single dose vials are available in cartons of 1 and cartons of 10 as follows: 25 mg/10 mL (2.5 mg/mL) NDC 70756-686-86 Package of 1 vial NDC 70756-686-10 Packages of 10 vials

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F), (See USP Controlled Room Temperature). Protect from freezing. Avoid excessive heat.

Protect from light, store in carton until ready to use. Discard unused portion. Manufactured by: Steril-Gene Life Sciences Pvt.

Ltd., No.45, Mangalam Main Road, Mangalam Village, Villianur Commune, Puducherry 605110, India. Distributed by: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Revised: April 2026, V-02

📋 Description 199 words ▾

11 DESCRIPTION Nicardipine hydrochloride injection, USP 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 greenish yellow, crystalline powder that melts at about 184°C to 189°C.

It is freely soluble in chloroform, methanol, and glacial acetic acid, sparingly soluble in anhydrous ethanol, slightly soluble in n-butanol, water,

0.01M potassium dihydrogen phosphate, acetone, and dioxane, very slightly soluble in ethyl acetate, and practically insoluble in benzene, ether, and hexane. 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 USP in Water for Injection, USP with 48 mg Sorbitol, NF, buffered to pH 3.5 with 0.525 mg citric acid monohydrate, USP and 0.09 mg sodium hydroxide, NF. Additional citric acid and/or sodium hydroxide may have been added to adjust pH. pic

🔬 Clinical Studies 157 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. At the end of a 48-hour infusion at 4 mg/hr, the decreases were 26 mmHg (17%) in systolic blood pressure and 20.7 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 ≤95 mmHg or ≥25 mmHg decrease and systolic blood pressure ≤160 mmHg, was 77 ± 5.2 minutes. The average maintenance dose was 8 mg/hr.

The mean time to therapeutic response for postoperative hypertension, defined as ≥15% reduction in diastolic or systolic blood pressure, was 11.5 ± 0.8 minutes. The average maintenance dose was 3 mg/hr.

🧪 Nonclinical Toxicology ~1 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- 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 (about 8 times the oral MRHD based on body surface area (mg/m 2 )).

📄 Package Label / Principal Display Panel 20 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 25mg/10mL(2.5mg/mL) NDC 70756-686-86 Package of 1 vial 25mg/10mL(2.5mg/mL) NDC 70756-686-10 Packages of 10 vials Label Carton

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?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Lifestar Pharma LLC. Listing status can change — the directory data on this page refreshes weekly.
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Lifestar Pharma LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
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This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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Yes — this NDC cross-references HCPCS code J2404 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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