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NITROGLYCERIN IN DEXTROSE 20 mg/100mL Injection, 250 mL — NDC 51662-1332-1 (Billing 51662-1332-01)

by HF Acquisition Co LLC, DBA HealthFirst · 250 mL in 1 BOTTLE, GLASS

This is a package of 250 mL of NITROGLYCERIN IN DEXTROSE 20 mg/100mL Injection from HF Acquisition Co LLC, DBA HealthFirst, marketed since Nov 2018 and currently FDA-listed. It is this product's only package size.

NDC 51662-1332-01
🏷️ FDA NDC (as labeled) 51662-1332-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 51662-1332-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
51662 labeler · 1332 product · 1 package
Package marketed since
Nov 26, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5166213321 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51662-1332-1
Product NDC 51662-1332
11-digit billing NDC 51662133201
RxCUI 312004
UNII G59M7S0WS3
Application # NDA019970
SPL Set ID 7b98d1fc-44b2-08a1-e053-2991aa0af3ab
Established class (EPC) Nitrate Vasodilator
Physiologic effect Vasodilation
Chemical class Nitrates
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-11-26
Route INTRAVENOUS
Dosage form INJECTION
Substance NITROGLYCERIN
Quick answers
  • RxCUI (RxNorm): 312004
Why two NDCs? The FDA registers this code as 51662-1332-1 — 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 → 51662-1332-01. 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 Nitrate Vasodilator class.

Pharmacologic class Nitrate Vasodilator
Drug family (ATC) Organic nitrates, Muscle relaxants
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
  • It is mainly used to relieve or prevent angina, which is chest pain from coronary artery disease. Rectal ointment treats chronic anal fissure pain, and IV forms are used in hospita...
  • Use your spray or tablet at the first sign of an attack, ideally sitting down. You can repeat it about every 5 minutes, up to three doses in 15 minutes. If the pain continues or fe...
  • How do I use it during an angina attack?
  • Headache is the most common one, and it often eases with continued use. You may also feel lightheaded. Sit down if you feel dizzy, and call for help if you faint or feel very weak,...
📖 Read our full Nitroglycerin guide →
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.
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
51662-1332-01 You're viewing this Main listing 250 mL in 1 BOTTLE, GLASS 2018-11-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nitroglycerin In Dextrose 20 mg/100mL 00338-1049-02 Baxter 12 bottles — — FDA listed —
Nitroglycerin In Dextrose 20 mg/100mLthis 51662-1332-01 HF 250 ml — — FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2018
On the market since
Nov 2018
📍
2026
Currently FDA-listed
8 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

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

LabelerHF Acquisition Co LLC, DBA HealthFirst
Application holderBAXTER HEALTHCARE CORP
FDA applicationNDA019970 (NDA)
Labeler code51662
First marketedNov 2018
Product typeHuman Prescription Drug
Portfolio333 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 49 words ▾

INDICATIONS & USAGE Nitroglycerin in 5% Dextrose Injection is indicated for treatment of peri-operative hypertension; for control of heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and ß-blockers; and for induction of intraoperative hypotension.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE & ADMINISTRATION Nitroglycerin in 5% Dextrose Injection is intended for intravenous administration using sterile equipment. Administer Nitroglycerin in 5% Dextrose Injection only via an infusion pump that can maintain a constant infusion rate. Do not use a container which has lost its vacuum, or one in which particulate matter is visible.

Dosage is affected by the type of infusion set used (see WARNINGS ). Although the usual adult starting dose in published studies has been 25 mcg/min or more, these studies used PVC tubing, so the delivered doses were less than those reported. When nonadsorptive tubing is used, doses must be reduced (see WARNINGS and PRECAUTIONS ).

The dosage must be determined by the patient’s individual requirement and depending on the required response and possible adverse effects (see ADVERSE REACTIONS ). Even using nonadsorptive tubing, the dose necessary to achieve a given response will vary greatly from patient to patient. Patients with normal or low left-ventricular filling pressure (e.g., patients with uncomplicated angina pectoris) may respond fully to as little as 5 mcg/min, while other patients may require a dose that is one or even two orders of magnitude higher.

Continuous monitoring of blood pressure and heart rate is necessary in all patients receiving this medication; in many cases, invasive monitoring of pulmonary capillary wedge pressure will also be indicated. Lower concentrations of Nitroglycerin in 5% Dextrose Injection increase the potential precision of dosing, but these concentrations increase the total fluid volume that must be delivered to the patient. Total fluid load may be a dominant consideration in patients with compromised function of the heart, liver, and/or kidneys.

The necessary flow rates to achieve various dose rates with the available concentrations are shown in the following table. Using nonadsorptive tubing, the initial adult dosage of Nitroglycerin in 5% Dextrose Injection should be 5 mcg/min. Subsequent titration must be guided by the clinical results, with dose increments becoming more cautious as partial response is seen.

Initial titration should be in 5 mcg/min increments at intervals of 3 to 5 minutes. If no response is seen at 20 mcg/min, increments of 10 and even 20 mcg/min can be used. Once some hemodynamic response is observed, dosage increments should be smaller and less frequent.

When the concentration is changed, the tubing must be disconnected from the patient and flushed with the new solution before therapy is continued. If this precaution is not taken, then depending upon the tubing, pump, and flow rate used, it might be several hours before nitroglycerin is delivered at the desired rate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not administer unless the solution is clear and the seal is intact. Do not add supplementary medication to Nitroglycerin in 5% Dextrose Injection. Infusion Rate (mL/h) = [Dose (mcg/min) x 60 min/h] Concentration (mcg/mL) Example calculations for infusion rates are as follows: Example 1: for a dose of 30 µg/min using a 100 mcg/mL concentration, the infusion rate would be as follows: Infusion Rate (mL/h) = [30 (mcg/min) x 60 (min/h)] = 18 (mL/h) 100 (mcg/mL) Example 2: for a dose of 240 mcg/min using a 400 mcg/mL concentration, the infusion rate would be as follows: Infusion Rate (mL/h) = [5 (mcg/min) x 60 (min/h)] = 36 (mL/h) 400 (mcg/mL)

⛔ Contraindications 111 words ▾

CONTRAINDICATIONS Nitroglycerin in 5% Dextrose Injection is contraindicated in patients who are allergic to it. In patients with pericardial tamponade, restrictive cardiomyopathy, or constrictive pericarditis, cardiac output is dependent upon venous return. Intravenous nitroglycerin is contraindicated in patients with these conditions.

Nitroglycerin is also contraindicated in patients with increased intracranial pressure. Do not use Nitroglycerin in 5% Dextrose Injection in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors) such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia.

Do not use Nitroglycerin in 5% Dextrose Injection in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

⚠️ Warnings ~1 min read ▾

WARNINGS Use of PVC (polyvinyl chloride) tubing in infusion sets may lead to loss of active ingredient due to adsorption of nitroglycerin to PVC tubing, therefore dosage is affected (see DOSAGE & ADMINISTRATION ). Nitroglycerin adsorption by PVC tubing is increased when the tubing is long, the flow rates are low, and the nitroglycerin concentration of the solution is high. The delivered fraction of the solution's original nitroglycerin content has been 20-60% in published studies using PVC tubing; the fraction varies with time during a single infusion, and no simple correction factor can be used.

PVC tubing has been used in most published studies of intravenous nitroglycerin, but the reported doses have been calculated by simply multiplying the flow rate of the solution by the solution's original concentration of nitroglycerin. The actual doses delivered have been less, sometimes much less, than those reported. Relatively non-adsorptive intravenous administration sets are available.

If intravenous nitroglycerin is administered through non-adsorptive tubing, doses based upon published reports will generally be too high. Some in-line intravenous filters also adsorb nitroglycerin; these filters should be avoided. Solutions containing dextrose without electrolytes should not be administered through the same administration set as blood, as this may result in pseudoagglutination or hemolysis.

The intravenous administration of solutions may cause fluid overloading resulting in dilution of serum electrolyte concentrations, overhydration and congested states of pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration of the injections.

🤒 Adverse Reactions 204 words ▾

ADVERSE REACTIONS Adverse reactions to nitroglycerin are generally dose-related and almost all of these reactions are the result of nitroglycerin's activity as a vasodilator. Headache, which may be severe, is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses.

Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur. Hypotension occurs infrequently, but in some patients it may be severe enough to warrant discontinuation of therapy. Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon.

Allergic reactions to nitroglycerin are also uncommon, and the great majority of those reported have been cases of contact dermatitis or fixed drug eruptions in patients receiving nitroglycerin in ointments or patches. There have been a few reports of genuine anaphylactoid reactions, and these reactions can probably occur in patients receiving nitroglycerin by any route. Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients.

Methemoglobinemia is so infrequent at these doses that further discussion of its diagnosis and treatment is deferred (see OVERDOSAGE ). Dyspnea has also been reported. Data are not available to allow estimation of the frequency of adverse reactions during treatment with Nitroglycerin in 5% Dextrose Injection.

🆘 Overdosage ~2 min read ▾

OVERDOSAGE Signs and symptoms of overdose are generally similar to the described adverse reactions (see ADVERSE REACTIONS ). There is no specific antidote for overdose of nitroglycerin. The risk of overdose can be minimized by close monitoring during treatment.

Hemodynamic Effects: The ill effects of nitroglycerin overdose are generally the results of nitroglycerin's capacity to induce vasodilation, venous pooling, reduced cardiac output, and hypotension. These hemodynamic changes may have protean manifestations, including increased intracranial pressure, with any or all of persistent throbbing headache, confusion, and moderate fever; vertigo; palpitations; visual disturbances; nausea and vomiting (possibly with colic and even bloody diarrhea); syncope (especially in the upright posture); air hunger and dyspnea, later followed by reduced ventilatory effort; diaphoresis, with the skin either flushed or cold and clammy; heart block and bradycardia; paralysis; coma; seizures; and death.

Laboratory determinations of serum levels of nitroglycerin and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of nitroglycerin overdose. No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of nitroglycerin and its active metabolites. Similarly, it is not known which -if any- of these substances can usefully be removed from the body by hemodialysis.

No specific antagonist to the vasodilator effects of nitroglycerin is known, and no intervention has been subject to controlled study as a therapy of nitroglycerin overdose. Because the hypotension associated with nitroglycerin overdose is the result of venodilatation and arterial hypovolemia, prudent therapy in this situation should be directed toward increase in central fluid volume. Passive elevation of the patient's legs may be sufficient, but intravenous infusion of normal saline or similar fluid may also be necessary.

The use of epinephrine or other arterial vasoconstrictors in this setting is likely to do more harm than good. In patients with renal disease or heart failure, therapy resulting in central volume expansion is not without hazard. Treatment of nitroglycerin overdose in these patients may be subtle and difficult, and invasive monitoring may be required.

Methemoglobinemia: Nitrate ions liberated during metabolism of nitroglycerin can oxidize hemoglobin into methemoglobin. Even in patients totally without cytochrome b5 reductase activity, however, and even assuming that the nitrate moieties of nitroglycerin are quantitatively applied to oxidation of hemoglobin, about 1 mg/kg of nitroglycerin should be required before any of these patients manifests clinically significant (≥ 10%) methemoglobinemia. In patients with normal reductase function, significant production of methemoglobin should require even larger doses of nitroglycerin.

In one study in which 36 patients received 2-4 weeks of continuous nitroglycerin therapy at 3.1 to 4.4 mg/hr, the average methemoglobin level measured was 0.2%; this was comparable to that observed in parallel patients who received placebo. Cases of methemoglobinemia have been reported with moderate doses of organic nitrates. Methemoglobin levels are available from most clinical laboratories.

The diagnosis should be suspected in patients who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial pO2. Classically, methemoglobinemic blood is described as chocolate brown, without color change on exposure to air. When methemoglobinemia is diagnosed, discontinue treatment of nitroglycerin.

If condition is not reversed, treat with methylene blue, 1-2 mg/kg intravenously.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload).

Dilatation of the coronary arteries also occurs. The relative importance of preload reduction, afterload reduction, and coronary dilatation remains undefined. Dosing regimens for most chronically used drugs are designed to provide plasma concentrations that are continuously greater than a minimally effective concentration.

This strategy is inappropriate for organic nitrates. Several well-controlled clinical trials have used exercise testing to assess the anti-anginal efficacy of continuously-delivered nitrates. In the large majority of these trials, active agents were indistinguishable from placebo after 24 hours (or less) of continuous therapy.

Attempts to overcome nitrate tolerance by dose escalation, even to doses far in excess of those used acutely, have consistently failed. Only after nitrates have been absent from the body for several hours has their anti-anginal efficacy been restored. Pharmacokinetics: The volume of distribution of nitroglycerin is about 3 L/kg, and nitroglycerin is cleared from this volume at extremely rapid rates, with a resulting serum half-life of about 3 minutes.

The observed clearance rates (close to 1 L/kg/min) greatly exceed hepatic blood flow; known sites of extrahepatic metabolism include red blood cells and vascular walls. The first products in the metabolism of nitroglycerin are inorganic nitrate and the 1,2-and 1,3- dinitroglycerols. The dinitrates are less effective vasodilators than nitroglycerin, but they are longer-lived in the serum, and their net contribution to the overall effect of chronic nitroglycerin regimens is not known.

The dinitrates are further metabolized to (non-vasoactive) mononitrates and, ultimately, to glycerol and carbon dioxide. To avoid development of tolerance to nitroglycerin, drug-free intervals of 10-12 hours are known to be sufficient; shorter intervals have not been well studied. In one well-controlled clinical trial, subjects receiving nitroglycerin appeared to exhibit a rebound or withdrawal effect, so that their exercise tolerance at the end of the daily drug-free interval was less than that exhibited by the parallel group receiving placebo.

Clinical Trials: Blinded, placebo-controlled trials of intravenous nitroglycerin have not been reported, but multiple investigators have reported open-label studies, and there are scattered reports of studies in which intravenous nitroglycerin was tested in blinded fashion against sodium nitroprusside. In each of these studies, therapeutic doses of intravenous nitroglycerin were found to reduce systolic and diastolic arterial blood pressure. The heart rate was usually increased, presumably as a reflexive response to the fall in blood pressure.

Coronary perfusion pressure was usually, but not always, maintained. Intravenous nitroglycerin reduced central venous pressure (CVP), right atrial pressure (RAP), pulmonary arterial pressure (PAP), pulmonary-capillary wedge pressure (PCWP), pulmonary vascular resistance (PVR), and systemic vascular resistance (SVR). When these parameters were elevated, reducing them toward normal usually caused a rise in cardiac output.

Conversely, intravenous nitroglycerin usually reduced cardiac output when it was given to patients whose CVP, RAP, PAP, PCWP, PVR, and SVR were all normal. Most clinical trials of intravenous nitroglycerin have been brief; they have typically followed hemodynamic parameters during a single surgical procedure. In one careful study, one of… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 121 words ▾

HOW SUPPLIED NITROGLYCERIN IN 5% DEXTROSE INJECTION is supplied in the following dosage forms. NDC 51662-1332-1 NITROGLYCERIN IN 5% DEXTROSE INJECTION 50mg PER 250mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Nitroglycerin in 5% Dextrose Injection is supplied in glass container as follows: Minimize exposure of pharmaceutical products to heat. Avoid excessive heat.

Protect from freezing. Store the product at room temperature (25°C). Brief exposure up to 40°C does not adversely affect the product.

Protect from light until time of use. Discard any unused portion. Baxter Healthcare Corporation Deerfield, IL 60015 Printed in USA Baxter is a registered trademark of Baxter International Inc.

07-19-76-571 Rev. August 2016 HOW SUPPLIED

📋 Description 198 words ▾

DESCRIPTION Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is whose empiric formula is C3H5N3O9, and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins. Dextrose (Dextrose Hydrous, USP) is D-glucose monohydrate, a hexose sugar whose structural formula is whose empiric formula is C6H12O6 • H2O, and whose molecular weight is 198.17.

Dextrose is derived from corn. Nitroglycerin in 5% Dextrose Injection is a sterile, nonpyrogenic solution of nitroglycerin and dextrose in water for injection. The solution is clear and practically colorless.

Each 100 mL contains 10 mg, 20 mg, or 40 mg nitroglycerin (added as Diluted Nitroglycerin, USP with propylene glycol); 5 g Dextrose Hydrous, USP; 0.84 mL Alcohol, USP (added as a dissolution aid); and 105 mg Citric Acid Hydrous, USP (added as a buffer). The pH of the solution is adjusted with sodium hydroxide and, if necessary, hydrochloric acid. Although dry nitroglycerin is explosive, nitroglycerin in 5% dextrose is not.

Composition, osmolarity and pH are given in Table 1. * Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥600 mOsmol/L) may cause vein damage. STRUCTURE 1 STRUCTURE 2 DESCRIPTION

⚠️ Precautions ~3 min read ▾

PRECAUTIONS Severe hypotension and shock may occur with even small doses of nitroglycerin. Monitor patients who may be volume depleted or who, for whatever reason, are already hypotensive. Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris.

Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy. Tolerance development and occurrence of cross tolerance to other nitro compounds have been reported. In industrial workers who have long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs.

Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence. Some clinical trials in angina patients have provided nitroglycerin for about 12 continuous hours of every 24-hour day. During the nitrate-free intervals in some of these trials, anginal attacks have been more easily provoked than before treatment, and patients have demonstrated hemodynamic rebound and decreased exercise tolerance.

The importance of these observations to the routine, clinical use of intravenous nitroglycerin is not known. Lower concentrations of Nitroglycerin in 5% Dextrose Injection increase the potential precision of dosing, but these concentrations increase the total fluid volume that must be delivered to the patient. Total fluid load may be a dominant consideration in patients with compromised function of the heart, liver, and/or kidneys.

Administer nitroglycerin in 5% Dextrose Injection via an infusion pump that can maintain a constant infusion rate. Intracoronary injection of Nitroglycerin in 5% Dextrose Injection has not been studied. Monitor patients with known sub-clinical or overt diabetes mellitus when using solutions containing dextrose.

Laboratory Tests: Because of the propylene glycol content of intravenous nitroglycerin, serum triglyceride assays that rely on glycerol oxidase may give falsely elevated results in patients receiving this medication. Drug Interactions: The vasodilating effects of nitroglycerin may be additive with those of antihypertensives (e.g., beta-blockers, calcium channel blockers and tricyclic antidepressants) and may cause increased hypotensive effects.. Concomitant use of Nitroglycerin in 5% Dextrose Injection with phosphodiesterase inhibitors (e.g. sildenafil, tadalafil, or vardenafil) can cause hypotension and is contraindicated (see CONTRAINDICATIONS ).

Concomitant use of Nitroglycerin in 5% Dextrose Injection with riociguat, a soluble guanylate cyclase stimulator, can cause hypotension and is contraindicated (see CONTRAINDICATIONS ). Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Nitroglycerin at higher dosages may interfere with the anticoagulant effect of heparin.

Intravenous nitroglycerin can induce heparin resistance. Administration of Nitroglycerin in 5% Dextrose Injection through the same infusion set as blood can result in pseudoagglutination and hemolysis. Do not mix Nitroglycerin in 5% Dextrose Injection with any other medication of any kind.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Animal carcinogenesis studies with injectable nitroglycerin have not been performed. Rats receiving up to 434 mg/kg/day of dietary nitroglycerin for 2 years developed dose-related fibrotic and neoplastic changes in liver, including carcinomas, and interstitial cell tumors in testes. At high dose, the incidences of hepatocellular carcinomas in both sexes were 52% vs.

0% in controls and incidences of testicular tumors were 52% vs. 8% in controls. Lifetime dietary administration of up to 1058 mg/kg/day of nitroglycerin was not tumorigenic in mice.

Nitroglycerin was weakly mutagenic in Ames tests performed in two different laboratories. Nevertheless, there was no evidence of mutagenici… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 13 words ▾

PRINCIPAL LABEL DISPLAY, BOTTLE LABEL BOTTEL

PRINCIPAL DISPLAY PANEL, SERIALIZED LABELING SERIALIZED LABELING

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

About this NDC listing & data coverage

Finished prescription product
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.
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.
Is this package still being marketed?
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 HF Acquisition Co LLC, DBA HealthFirst. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
HF Acquisition Co LLC, DBA HealthFirst 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.
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.