NDC 23155-620 Phenylephrine Hydrochloride
Injection Intravenous

Product Information

What is NDC 23155-620?

The NDC code 23155-620 is assigned by the FDA to the product Phenylephrine Hydrochloride which is a human prescription drug product labeled by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. The product's dosage form is injection and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 23155-620-41 25 vial in 1 carton / 1 ml in 1 vial (23155-620-31). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code23155-620
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Phenylephrine Hydrochloride
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Phenylephrine Hydrochloride
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
Phenylephrine Hydrochloride
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormInjection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Intravenous - Administration within or into a vein or veins.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.
Labeler Code23155
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
NDC Code Structure

What are the uses for Phenylephrine Hydrochloride?

Product Packages

NDC Code 23155-620-41

Package Description: 25 VIAL in 1 CARTON / 1 mL in 1 VIAL (23155-620-31)

Product Details

What are Phenylephrine Hydrochloride Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Phenylephrine Hydrochloride Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Phenylephrine Hydrochloride Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Phenylephrine Hydrochloride Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents

1 Indications And Usage

Phenylephrine Hydrochloride is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia.

2.1 General Administration Instructions

Phenylephrine hydrochloride must be diluted before administration as bolus intravenous infusion or continuous intravenous infusion.

Inspect the solution for particulate matter and discoloration prior to administration. The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions. Discard any unused portion.

During phenylephrine hydrochloride administration:

  • Correct intravascular volume depletion.
  • Correct acidosis. Acidosis may reduce the effectiveness of phenylephrine.

2.2 Preparing A 100 Mcg/Ml Solution For Bolus Intravenous Administration

For bolus intravenous administration, withdraw 10 mg (1 mL of a 10 mg/mL concentration) of phenylephrine injection and dilute with 99 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. This will yield a final concentration of 100 mcg/mL. Withdraw an appropriate dose from the 100 mcg/mL solution prior to bolus intravenous administration.

2.3 Preparing A Solution For Continuous Intravenous Infusion

For continuous intravenous infusion, withdraw 10 mg (1 mL of 10 mg/mL concentration) of phenylephrine hydrochloride injection and add to 500 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (providing a final concentration of 20 mcg/mL).

2.4 Dosing For Perioperative Setting

In adult patients undergoing surgical procedures with either neuraxial anesthesia or general anesthesia:

  • 50 mcg to 250 mcg by intravenous bolus administration. The most frequently reported initial bolus dose is 50 mcg or 100 mcg.
  • 0.5 mcg/kg/min to 1.4 mcg/kg/min by intravenous continuous infusion titrated to blood pressure goal.

2.5 Dosing For Septic Or Other Vasodilatory Shock

In adult patients with septic or other vasodilatory shock:

  • No bolus.
  • 0.5 mcg/kg/min to 6 mcg/kg/min by intravenous continuous infusion, titrated to blood pressure goal. Doses above 6 mcg/kg/min do not show significant incremental increase in blood pressure.

3 Dosage Forms And Strengths

Injection: 10 mg/mL phenylephrine hydrochloride is supplied in one vial size:

    1 mL single dose vial (10 mg of phenylephrine hydrochloride per vial)             

4 Contraindications

The use of phenylephrine hydrochloride is contraindicated in patients with:

  • Hypersensitivity to it or any of its components

5.1 Exacerbation Of Angina, Heart Failure, Or Pulmonary Arterial Hypertension

Because of its pressor effects, phenylephrine hydrochloride can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.

5.2 Bradycardia

Phenylephrine hydrochloride can cause severe bradycardia and decreased cardiac output.

5.3 Risk In Patients With Autonomic Dysfunction

The pressor response to adrenergic drugs, including phenylephrine, can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries.

5.4 Skin And Subcutaneous Necrosis

Extravasation of phenylephrine can cause necrosis or sloughing of tissue.

5.5 Pressor Effect With Concomitant Oxytocic Drugs

Oxytocic drugs potentiate the pressor effect of sympathomimetic pressor amines including phenylephrine hydrochloride [see Drug Interactions (7.1)], with the potential for hemorrhagic stroke.

5.6 Allergic Reactions

This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

5.7 Peripheral And Visceral Ischemia

Phenylephrine hydrochloride can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.

5.8 Renal Toxicity

Phenylephrine hydrochloride can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function.

6 Adverse Reactions

The following adverse reactions associated with the use of phenylephrine hydrochloride were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Cardiac disorders: Bradycardia, AV block, ventricular extrasystoles, myocardial ischemia

Gastrointestinal disorders: Nausea, vomiting

General disorders and administrative site conditions: Chest pain, extravasation

Immune system disorders: Sulfite sensitivity

Nervous system disorders: Headache, nervousness, paresthesia, tremor

Psychiatric disorders: Excitability

Respiratory: Pulmonary edema, rales

Skin and subcutaneous tissue disorders: Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation

Vascular disorders: Hypertensive crisis

7.1 Agonists

The pressor effect of phenylephrine hydrochloride is increased in patients receiving:

  • Monoamine oxidase inhibitors (MAOI), such as selegiline.
  • β-adrenergic blockers
  • α-2 adrenergic agonists, such as clonidine
  • Steroids
  • Tricyclic antidepressants
  • Norepinephrine transport inhibitors, such as atomoxetine
  • Ergot alkaloids, such as methylergonovine maleate
  • Centrally-acting sympatholytic agents, such as guanfacine or reserpine
  • Atropine sulfate

7.2 Antagonists

α-adrenergic blocking agents, including phenothiazines (e.g., chlorpromazine) and amiodarone block phenylephrine and are in turn blocked by phenylephrine.

8.1 Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with intravenous phenylephrine. It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed.

8.2 Labor And Delivery

The most common maternal adverse reactions reported in studies of phenylephrine use during neuraxial anesthesia during cesarean delivery include nausea and vomiting, which are commonly associated with hypotension, bradycardia, reactive hypertension, and transient arrhythmias. Phenylephrine does not appear to cause a decrease in placental perfusion sufficient to alter either the neonate Apgar scores or blood-gas status.

8.3 Nursing Mothers

It is not known whether this drug is excreted in human milk.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of phenylephrine 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.

8.6 Hepatic Impairment

In patients with liver cirrhosis [Child Pugh Class A (n=3), Class B (n=5) and Class C (n=1)], dose-response data indicate decreased responsiveness to phenylephrine. Consider using larger doses than usual in hepatic impaired subjects.

8.7 Renal Impairment

In patients with end stage renal disease (ESRD) undergoing hemodialysis, dose-response data indicates increased responsiveness to phenylephrine. Consider using lower doses of phenylephrine hydrochloride in ESRD patients.

10 Overdosage

Overdose of phenylephrine hydrochloride can cause a rapid rise in blood pressure. Symptoms of overdose include headache, vomiting, hypertension, reflex bradycardia, and cardiac arrhythmias including ventricular extrasystoles and ventricular tachycardia, and may cause a sensation of fullness in the head and tingling of the extremities.

Consider using an α-adrenergic antagonist.

11 Description

Phenylephrine hydrochloride is a synthetic sympathomimetic agent in sterile form for parenteral injection. Chemically, phenylephrine hydrochloride is (-)-m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and has the following structural formula:

Phenylephrine hydrochloride is freely soluble in water and ethanol. Phenylephrine hydrochloride is sensitive to light.

Phenylephrine Hydrochloride Injection, USP is a clear, colorless solution essentially free of visible particles. Each mL contains: phenylephrine hydrochloride USP 10 mg; sodium chloride USP 3.5 mg; sodium citrate dehydrate USP 4 mg; citric acid monohydrate USP 1 mg; and sodium metabisulfite NF 2 mg in water for injection. The pH may be adjusted in the range of 3.0 to 6.5 with sodium hydroxide NF and/or hydrochloric acid NF, if necessary.

12.1 Mechanism Of Action

Phenylephrine hydrochloride is an α-1 adrenergic receptor agonist.

12.2 Pharmacodynamics

Phenylephrine is the active moiety. Metabolites are inactive at both the α-1and α-2 adrenergic receptors. Following parenteral administration of phenylephrine hydrochloride, increases in systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, and total peripheral vascular resistance are observed. The onset of blood pressure increase following an intravenous bolus phenylephrine hydrochloride administration is rapid and the effect may persist for up to 20 minutes. As mean arterial pressure increases following parenteral doses, vagal activity also increases, resulting in reflex bradycardia.

Most vascular beds are constricted, including renal, splanchnic, and hepatic.

12.3 Pharmacokinetics

Following an intravenous infusion of phenylephrine hydrochloride, the effective half-life was approximately 5 minutes. The steady-state volume of distribution (340 L) exceeded the body volume by a factor of 5, suggesting a high distribution into certain organ compartments. The average total serum clearance (2095 mL/min) was close to one-third of the cardiac output.

A mass balance study showed that phenylephrine is extensively metabolized by the liver with only 12% of the dose excreted unchanged in the urine. Deamination by monoamino oxidase is the primary metabolic pathway resulting in the formation of the major metabolite (m-hydroxymandelic acid) which accounts for 57% of the total administered dose.

14 Clinical Studies

Increases in systolic and mean blood pressure following administration of phenylephrine were observed in 42 literature-based studies in the perioperative setting, including 26 studies where phenylephrine was used in low- risk (ASA 1 and 2) pregnant women undergoing neuraxial anesthesia during cesarean delivery, 3 studies in non-obstetric surgery under neuraxial anesthesia, and 13 studies in patients undergoing surgery under general anesthesia. Mean arterial blood pressure increases were also observed in two double-blind, active-controlled studies in patients with septic shock.

16 How Supplied/Storage And Handling

Phenylephrine Hydrochloride Injection, USP, is supplied as follows:

  • NDC 23155-620-41: 1 mL single dose vials packaged in cartons containing 25 vials per carton.
  • Store at 20° to 25°C (68° to 77°F); excursions permitted 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature]. Protect from light. Keep covered in carton until time of use. The 1 mL vials are for single use only; The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions. Discard any unused portion.

17 Patient Counseling Information

Inform patients, families, or caregivers that the primary side effect of phenylephrine is hypertension and rarely, hypertensive crisis. Patients may experience bradycardia (slow heart rate), which in some cases may produce heart block or other cardiac arrhythmias, extra ventricular beats, myocardial ischemia in patients with underlying cardiac disease, and pulmonary edema (fluid in the lungs) or rales. Common, less serious symptoms include the following:

  • chest pain
  • skin or tissue damage if the drug leaks out of the venous catheter into the surrounding tissue
  • headache, nervousness, tremor, numbness/tingling (paresthesias) in hands or feet
  • nausea, vomiting
  • excitability, dizziness, sweating, flushing
  • Manufactured by:

    Emcure Pharmaceuticals Ltd.,

    Plot No. SM-14, 15 & 16/1, GIDC, Sanand - II, Charal,

    Tal - Sanand, Ahmedabad, Gujarat 382110, India.         

    Manufactured for:

    Avet Pharmaceuticals Inc.

    East Brunswick, NJ 08816

    1.866.901.DRUG (3784)

    Revised. 04/2022

Package Label.Principal Display Panel

NDC 23155-620-31

Phenylephrine HCl Injection, USP

10 mg/mL

For Intravenous Use

Dilute Before Use

1 mL Single Dose Vial



NDC 23155-620-41

Phenylephrine HCl Injection, USP

10 mg/mL

For Intravenous Use

Dilute Before Use

25 x 1 mL Single Dose Vials


* Please review the disclaimer below.