Home › NDC Lookup › Ingredients › Nicardipine Hydrochloride › 70710-2010-09
💊image loading
(from DailyMed)

Nicardipine Hydrochloride 20 mg Capsule, 90-count

by Zydus Pharmaceuticals USA Inc. · 90 CAPSULE in 1 BOTTLE (70710-2010-9)
NDC 70710-2010-09
🏷️ FDA NDC (as labeled) 70710-2010-9 billing pads the package segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Aug 6, 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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 70710-2010-9
Product NDC 70710-2010
11-digit billing NDC 70710201009
RxCUI 858613, 858616
UNII K5BC5011K3
UPC 0370710201197
Application # ANDA218638
SPL Set ID 861247cc-3edf-4497-b230-2147489548b3
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 Discontinued
FDA listing status Discontinued by firm (certified through Jul 2026)
Marketing start 2025-08-01
Route ORAL
Dosage form CAPSULE
Substance NICARDIPINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 70710-2010-9 — a 5-4-1 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 package segment → 70710-2010-09. 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.

🏭 Manufacturer & labeler

LabelerZydus Pharmaceuticals USA Inc.
Application holderCHARTWELL RX SCIENCES LLC
FDA applicationANDA218638 (ANDA)
Labeler code70710
First marketedAug 2025
Product typeHuman Prescription Drug
Portfolio451 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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Nicardipine is a calcium channel blocker — a type of blood pressure medication. The oral capsules treat two things: high blood pressure and chronic stable angina, which is chest pa...
  • It can, yes — dizziness, headaches, and flushing are among the more common side effects, since the medication works by widening blood vessels. Most people find these effects mild a...
  • Will nicardipine make me dizzy or give me headaches?
  • That depends on which medications. A few important ones to know about: if you take cyclosporine or tacrolimus (common transplant drugs), nicardipine can raise those drug levels sig...
📖 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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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.

💲 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 · Q2 2026 $2.32 $208.39 / 90 capsules
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nicardipine Hydrochloride 20 mg 35573-0457-85 Burel 90 capsules $1.122 AB Availability likely —
Nicardipine Hydrochloride 20 mg 62559-0205-90 ANI 90 capsules $1.122 AB Availability likely —
Nicardipine hydrochloride 20 mg 69238-2691-01 Amneal 90 capsules $1.122 AB Availability likely —
Nicardipine Hydrochloride 20 mg 69292-0620-90 Amici 90 capsules $1.122 AB Availability likely —
Nicardipine Hydrochloride 20 mg 69452-0436-19 Bionpharma 90 capsules $1.122 AB Availability likely —
Nicardipine Hydrochloride 20 mg 24658-0750-90 PuraCap 90 capsules — AB FDA listed —
Nicardipine Hydrochloride 20 mg 42806-0501-01 Epic 100 capsules — AB FDA listed —
Nicardipine Hydrochloride 20 mg 68462-0120-05 Glenmark 500 capsules — AB FDA listed —
Nicardipine Hydrochloride 20 mgthis 70710-2010-09 Zydus 90 capsules — — Discontinued —
Nicardipine Hydrochloride 20 mg 87564-0027-90 Amerisyn 90 capsules — AB 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

🏛️
2025
On the market since
Aug 2025
📍
2026
Currently FDA-listed
1 year 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70710-2010-09 You're viewing this 90 CAPSULE in 1 BOTTLE (70710-2010-9) 2025-08-01 Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 FDA registers it as 70710-2010-9, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70710-2010-09, written without dashes as 70710201009. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70710-2010-09, the first segment (70710) is the labeler code FDA assigned to Zydus Pharmaceuticals USA Inc.; the middle segment (2010) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (09) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Zydus Pharmaceuticals USA Inc. 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.
Do I need a prescription for this product?
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.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 86 words ▾

INDICATIONS AND USAGE I. Stable Angina: Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers.

II. Hypertension: Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs.

In administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see DOSAGE AND ADMINISTRATION ).

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Angina: The dose should be individually titrated for each patient beginning with 20 mg three times daily. Doses in the range of 20 to 40 mg three times a day have been shown to be effective. At least 3 days should be allowed before increasing the nicardipine hydrochloride capsules dose to ensure achievement of steady-state plasma drug concentrations.

Concomitant Use With Other Antianginal Agents 1. Sublingual NTG may be taken as required to abort acute anginal attacks during nicardipine hydrochloride capsules therapy. 2.

Prophylactic Nitrate Therapy: Nicardipine hydrochloride capsules may be safely coadministered with short- and long-acting nitrates. 3. Beta-blockers: Nicardipine hydrochloride capsules may be safely coadministered with beta-blockers (see Drug Interactions).

Hypertension: The dose of nicardipine hydrochloride should be individually adjusted according to the blood pressure response beginning with 20 mg three times daily. The effective doses in clinical trials have ranged from 20 mg to 40 mg three times daily. The maximum blood pressure lowering effect occurs approximately 1 to 2 hours after dosing.

To assess the adequacy of blood pressure response, the blood pressure should be measured at trough (8 hours after dosing). Because of the prominent peak effects of nicardipine, blood pressure should be measured 1 to 2 hours after dosing, particularly during initiation of therapy (see PRECAUTIONS : Blood Pressure , INDICATIONS and CLINICAL PHARMACOLOGY : Effects in Hypertension ). At least 3 days should be allowed before increasing the nicardipine hydrochloride dose to ensure achievement of steady-state plasma drug concentrations.

Concomitant Use With Other Antihypertensive Agents 1. Diuretics: Nicardipine hydrochloride capsules may be safely coadministered with thiazide diuretics. 2.

Beta-blockers: Nicardipine hydrochloride capsules may be safely coadministered with beta-blockers (see Drug Interactions ). Special Patient Populations: Renal Insufficiency: Although there is no evidence that nicardipine hydrochloride impairs renal function, careful dose titration beginning with 20 mg tid is advised (see PRECAUTIONS ). Hepatic Insufficiency: Nicardipine hydrochloride should be administered cautiously in patients with severely impaired hepatic function.

A suggested starting dose of 20 mg twice a day is advised with individual titration based on clinical findings maintaining the twice a day schedule (see PRECAUTIONS ). Congestive Heart Failure: Caution is advised when titrating nicardipine hydrochloride dosage in patients with congestive heart failure (see WARNINGS ).

⛔ Contraindications 53 words ▾

CONTRAINDICATIONS Nicardipine hydrochloride capsules are contraindicated in patients with hypersensitivity to the drug. Because part of the effect of nicardipine hydrochloride capsules are secondary to reduced afterload, the drug is also contraindicated in patients with advanced aortic stenosis. Reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance.

⚠️ Warnings 164 words ▾

WARNINGS Increased Angina: About 7% of patients in short-term, placebo-controlled angina trials have developed increased frequency, duration or severity of angina on starting nicardipine hydrochloride or at the time of dosage increases, compared with 4% of patients on placebo. Comparisons with beta-blockers also show a greater frequency of increased angina, 4% vs 1%. The mechanism of this effect has not been established (see ADVERSE REACTIONS ).

Use in Patients With Congestive Heart Failure: Although preliminary hemodynamic studies in patients with congestive heart failure have shown that nicardipine hydrochloride reduced afterload without impairing myocardial contractility, it has a negative inotropic effect in vitro and in some patients. Caution should be exercised when using the drug in congestive heart failure patients, particularly in combination with a beta-blocker. Beta-Blocker Withdrawal: Nicardipine hydrochloride is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be by gradual reduction of the dose of beta-blocker, preferably over 8 to 10 days.

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS In multiple-dose US and foreign controlled short-term (up to 3 months) studies 1910 patients received nicardipine hydrochloride alone or in combination with other drugs. In these studies adverse events were reported spontaneously; adverse experiences were generally not serious but occasionally required dosage adjustment and about 10% of patients left the studies prematurely because of them. Peak responses were not observed to be associated with adverse effects during clinical trials, but physicians should be aware that adverse effects associated with decreases in blood pressure (tachycardia, hypotension, etc.) could occur around the time of the peak effect.

Most adverse effects were expected consequences of the vasodilator effects of nicardipine hydrochloride. Angina: The incidence rates of adverse effects in anginal patients were derived from multicenter, controlled clinical trials. Following are the rates of adverse effects for nicardipine hydrochloride (n=520) and placebo (n=310), respectively, that occurred in 0.4% of patients or more.

These represent events considered probably drug-related by the investigator (except for certain cardiovascular events that were recorded in a different category). Where the frequency of adverse effects for nicardipine hydrochloride and placebo is similar, causal relationship is uncertain. The only dose-related effects were pedal edema and increased angina.

Percent of Patients With Adverse Effects in Controlled Studies (Incidence of Discontinuations Shown in Parentheses) Adverse Experience Nicardipine Hydrochloride Capsules (n=520) PLACEBO (n=310) Pedal Edema 7.1 (0) 0.3 (0) Dizziness 6.9 (1.2) 0.6 (0) Headache 6.4 (0.6) 2.6 (0) Asthenia 5.8 (0.4) 2.6 (0) Flushing 5.6 (0.4) 1.0 (0) Increased Angina 5.6 (3.5) 4.2 (1.9) Palpitations 3.3 (0.4) 0.0 (0) Nausea 1.9 (0) 0.3 (0) Dyspepsia 1.5 (0.6) 0.6 (0.3) Dry Mouth 1.4 (0) 0.3 (0) Somnolence 1.4 (0) 1.0 (0) Rash 1.2 (0.2) 0.3 (0) Tachycardia 1.2 (0.2) 0.6 (0) Myalgia 1.0 (0) 0.0 (0) Other Edema 1.0 (0) 0.0 (0) Paresthesia 1.0 (0.2) 0.3 (0) Sustained Tachycardia 0.8 (0.6) 0.0 (0) Syncope 0.8 (0.2) 0.0 (0) Constipation 0.6 (0.2) 0.6 (0) Dyspnea 0.6 (0) 0.0 (0) Abnormal ECG 0.6 (0.6) 0.0 (0) Malaise 0.6 (0) 0.0 (0) Nervousness 0.6 (0) 0.3 (0) Tremor 0.6 (0) 0.0 (0) In addition, adverse events were observed that are not readily distinguishable from the natural history of the atherosclerotic vascular disease in these patients.

Adverse events in this category each occurred in <0.4% of patients receiving nicardipine hydrochloride and included myocardial infarction, atrial fibrillation, exertional hypotension, pericarditis, heart block, cerebral ischemia, and ventricular tachycardia. It is possible that some of these events were drug-related. Hypertension: The incidence rates of adverse effects in hypertensive patients were derived from multicenter, controlled clinical trials.

Following are the rates of adverse effects for nicardipine hydrochloride (n=1390) and placebo (n=211), respectively, that occurred in 0.4% of patients or more. These represent events considered probably drug-related by the investigator. Where the frequency of adverse effects for nicardipine hydrochloride and placebo is similar, causal relationship is uncertain.

The only dose-related effect was pedal edema. Percent of Patients With Adverse Effects in Controlled Studies (Incidence of Discontinuations Shown in Parentheses) Adverse Experience Nicardipine Hydrochloride Capsules (n=1390) PLACEBO (n=211) Flushing 9.7 (2.1) 2.8 (0) Headache 8.2 (2.6) 4.7 (0) Pedal Edema 8.0 (1.8) 0.9 (0) Asthenia 4.2 (1.7) 0.5 (0) Palpitations 4.1 (1.0) 0.0 (0) Dizziness 4.0 (1.8) 0.0 (0) Tachycardia 3.4 (1.2) 0.5 (0) Nausea 2.2 (0.9) 0.9 (0) Somnolence 1.1 (0.1) 0.0 (0) Dyspepsia 0.8 (0.3) 0.5 (0) Insomnia 0.6 (0.1) 0.0 (0) Malaise 0.6 (0.1) 0.0 (0) Other Edema 0.6 (0.3) 1.4 (0) Abnormal Dreams 0.4 (0) 0.0 (0) Dry Mouth 0.4 (0.1) 0.0 (0) Nocturia 0.4 (0) 0.0 (0) Rash 0.4 (0.4) 0.0 (0) Vom…

🔄 Drug Interactions ~1 min read ▾

Drug Interactions: Beta-Blockers: In controlled clinical studies, adrenergic beta-receptor blockers have been frequently administered concomitantly with nicardipine hydrochloride. The combination is well tolerated. Cimetidine: Cimetidine increases nicardipine hydrochloride plasma levels.

Patients receiving the two drugs concomitantly should be carefully monitored. Digoxin: Some calcium blockers may increase the concentration of digitalis preparations in the blood. Nicardipine hydrochloride usually does not alter the plasma levels of digoxin; however, serum digoxin levels should be evaluated after concomitant therapy with nicardipine hydrochloride is initiated.

Maalox ® 2 : Coadministration of Maalox TC had no effect on nicardipine hydrochloride absorption. Fentanyl Anesthesia: Severe hypotension has been reported during fentanyl anesthesia with concomitant use of a beta-blocker and a calcium channel blocker. Even though such interactions were not seen during clinical studies with nicardipine hydrochloride, an increased volume of circulating fluids might be required if such an interaction were to occur.

Cyclosporine: Concomitant administration of oral or intravenous nicardipine and cyclosporine results in elevated plasma cyclosporine levels through nicardipine inhibition of hepatic microsomal enzymes, including CYP3A4. Plasma concentrations of cyclosporine should therefore be closely monitored, and its dosage reduced accordingly, in patients treated with nicardipine. Tacrolimus: Concomitant administration of oral or 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. When therapeutic concentrations of furosemide, propranolol, dipyridamole, warfarin, quinidine or naproxen were added to human plasma (in vitro), the plasma protein binding of nicardipine hydrochloride was not altered.

🤰 Pregnancy ~2 min read ▾

Pregnancy: Pregnancy Category C. Nicardipine was 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 (25 times the maximum recommended antianginal or antihypertensive dose in man). No adverse effects on the fetus were observed when New Zealand albino rabbits were treated, during organogenesis, with up to 100 mg nicardipine/kg/day (a dose associated with significant mortality in the treated doe).

In pregnant rats administered nicardipine orally at up to 100 mg/kg/day (50 times the maximum recommended human dose) there was no evidence of embryolethality or teratogenicity. However, dystocia, reduced birth weights, reduced neonatal survival, and reduced neonatal weight gain were noted. There are no adequate and well-controlled studies in pregnant women.

Nicardipine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: Studies in rats have shown significant concentrations of nicardipine hydrochloride in maternal milk following oral administration. For this reason it is recommended that women who wish to breastfeed should not take this drug.

Pediatric Use: Safety and efficacy in patients under the age of 18 have not been established. Geriatric Use: Pharmacokinetic parameters did not differ between elderly hypertensive patients (≥65 years) and healthy controls after 1 week of nicardipine hydrochloride treatment at 20 mg tid. Plasma nicardipine hydrochloride concentrations in elderly hypertensive subjects were similar to plasma concentrations in healthy young adult subjects when nicardipine hydrochloride was administered at doses of 10, 20, and 30 mg tid, suggesting that the pharmacokinetics of nicardipine hydrochloride are similar in young and elderly hypertensive patients.

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 selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 170 words ▾

OVERDOSAGE Overdosage with a 600-mg single dose (15 to 30 times normal clinical dose) has been reported. Marked hypotension (blood pressure unobtainable) and bradycardia (heart rate 20 bpm in normal sinus rhythm) occurred, along with drowsiness, confusion and slurred speech. Supportive treatment with a vasopressor resulted in gradual improvement with normal vital signs approximately 9 hours posttreatment.

Based on results obtained in laboratory animals, overdosage 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 overdose standard measures (for example, evacuation of gastric contents, elevation of extremities, attention to circulating fluid volume, and urine output) including monitoring of cardiac and respiratory functions should be implemented.

The patient should be positioned so as 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 ▾

CLINICAL PHARMACOLOGY Mechanism of Action: Nicardipine hydrochloride is a calcium entry blocker (slow channel blocker or calcium ion antagonist) that 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 hydrochloride are more selective to vascular smooth muscle than cardiac muscle.

In animal models, nicardipine hydrochloride produces relaxation of coronary vascular smooth muscle at drug levels that cause little or no negative inotropic effect. Pharmacokinetics and Metabolism: Nicardipine hydrochloride is completely absorbed following oral doses administered as capsules. Plasma levels are detectable as early as 20 minutes following an oral dose and maximal plasma levels are observed within 30 minutes to 2 hours (mean T max = 1 hour).

While nicardipine hydrochloride is completely absorbed, it is subject to saturable first pass metabolism and the systemic bioavailability is about 35% following a 30-mg oral dose at steady-state. When nicardipine hydrochloride was administered 1 or 3 hours after a high-fat meal, the mean C max and mean AUC were lower (20% to 30%) than when nicardipine hydrochloride was given to fasting subjects. These decreases in plasma levels observed following a meal may be significant, but the clinical trials establishing the efficacy and safety of nicardipine hydrochloride were done in patients without regard to the timing of meals.

Thus, the results of these trials reflect the effects of meal-induced variability. The pharmacokinetics of nicardipine hydrochloride are nonlinear due to saturable hepatic first pass metabolism. Following oral administration, increasing doses result in a disproportionate increase in plasma levels.

Steady-state C max values following 20-, 30-, and 40-mg doses every 8 hours averaged 36, 88, and 133 ng/mL, respectively. Hence, increasing the dose from 20 to 30 mg every 8 hours more than doubled C max and increasing the dose from 20 to 40 mg every 8 hours increased C max more than threefold. A similar disproportionate increase in AUC with dose was observed.

Considerable inter-subject variability in plasma levels was also observed. Post-absorption kinetics of nicardipine hydrochloride are also non-linear, although there is a reproducible terminal plasma half-life that averaged 8.6 hours following 30- and 40-mg doses at steady-state (tid). The terminal half-life represents the elimination of less than 5% of the absorbed drug (measured by plasma concentrations).

Elimination over the first 8 hours after dosing is much faster with a half-life of 2 to 4 hours. Steady-state plasma levels are achieved after 2 to 3 days of tid dosing (every 8 hours) and are twofold higher than after a single dose. Nicardipine hydrochloride is highly protein bound (>95%) in human plasma over a wide concentration range.

Nicardipine hydrochloride is metabolized extensively by the hepatic cytochrome P450 enzymes, CYP2C8, 2D6, and 3A4; less than 1% of intact drug is detected in the urine. Following a radioactive oral dose in solution, 60% of the radioactivity was recovered in the urine and 35% in feces. Most of the dose (over 90%) was recovered within 48 hours of dosing.

Nicardipine hydrochloride does not induce its own metabolism, however, nicardipine causes inhibition of certain cytochrome P450 enzymes (including CYP3A4, CYP2D6, CYP2C8, and CYP2C19). Inhibition of these enzymes may result in increased plasma levels of certain drugs, including cyclosporine and tacrolimus (see Drug Interactions ). The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation of treatment.

Nicardipine hydrochloride plasma levels were higher in patients with mild renal impairment (baseline serum creatinine con…

🧬 Mechanism of Action 100 words ▾

Mechanism of Action: Nicardipine hydrochloride is a calcium entry blocker (slow channel blocker or calcium ion antagonist) that 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 hydrochloride are more selective to vascular smooth muscle than cardiac muscle.

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

📦 How Supplied / Storage and Handling 155 words ▾

HOW SUPPLIED Nicardipine hydrochloride capsules 20 mg are available as hard gelatin capsule with opaque light blue color cap imprinted "NAV" with black ink and opaque white color body imprinted "129" with black ink. These are supplied as follows: Bottles of 90 Capsules, NDC 70710-2010-9 Nicardipine hydrochloride capsules 30 mg are available as hard gelatin capsule with opaque blue color cap imprinted "NAV" with black ink and opaque light blue color body imprinted "130" with black ink. These are supplied as follows: Bottles of 90 Capsules, NDC 70710-2011-9 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] and dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.

2. The brands listed are trademarks of their respective owners and are not trademarks of the Zydus Pharmaceuticals USA Inc. Manufactured for: Zydus Pharmaceuticals USA Inc.

Pennington, NJ08534 Made in India 31290424 R0 May 2024

📋 Description 200 words ▾

DESCRIPTION Nicardipine hydrochloride capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride, USP. Nicardipine hydrochloride capsules are a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride, USP is a dihydropyridine structure with the 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 it has the following structure: Nicardipine Hydrochloride, USP Molecular Formula C 26 H 29 N 3 O 6 .

HCl Nicardipine hydrochloride, USP is a pale greenish-yellow, odorless, crystalline powder that melts at about 167°C to 171°C. It is freely soluble in methanol and acetic acid, sparingly soluble in ethanol, slightly soluble in water. It has a molecular weight of 515.99.

Nicardipine hydrochloride capsules are available in hard gelatin capsules containing 20-mg or 30-mg nicardipine hydrochloride, USP with magnesium stearate and pregelatinized starch as the inactive ingredients. The 20-mg strength is provided in opaque light blue cap and opaque white body, while the 30-mg capsules are provided in opaque blue cap and opaque light blue body. The capsule shells contains gelatin, titanium dioxide, and FD&C Blue No.

1. The black imprinting ink contains black iron oxide, potassium hydroxide and shellac. Image

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70710-2009-00 · Zydus 70710-2011-09 · Zydus →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.