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PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL Injection — NDC 31722-0345-31 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL Injection — NDC 31722-345-31 (Billing 31722-0345-31)

by Camber Pharmaceuticals, Inc. · 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE

This is a package of PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL Injection from Camber Pharmaceuticals, Inc., marketed since May 2024 and currently FDA-listed.

NDC 31722-0345-31
🏷️ FDA NDC (as labeled) 31722-345-31 billing pads the product segment with a zero
This package
Contains10 mL in 1 vial, pharmacy bulk package Pack sizes2 compare ↓
Product page 31722-0345-10 Also comes in: 10 mL 31722-345-10
Rx only Generic 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 →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 31722-345-31
Product NDC 31722-345
11-digit billing NDC 31722034531
NCPDP billing unit ML — per mL (volume)
RxCUI 1232651, 1666372
UNII 04JA59TNSJ
UPC 0331722343312, 0331722344050, 0331722345101
Application # ANDA218110
SPL Set ID 744da574-dfc9-4a22-8983-2ee15be2ea84
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-10
Route INTRAVENOUS
Dosage form INJECTION
Substance PHENYLEPHRINE HYDROCHLORIDE
TE code (Orange Book) AP1 · RLD · RS

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

GCN Seq No 005068
GCN 20310
HICL code 002087
Ingredient (HICL) Phenylephrine Hcl
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J5
Therapeutic class — intermediate (HIC2) Adrenergics
HIC3 code J5E
Therapeutic class — specific (HIC3) Sympathomimetic Agents
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name PHENYLEPHRINE 100 MG/10 ML VL
FDB brand name Phenylephrine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 005068
  • GCN: 20310
  • HICL (First Databank): 002087
  • AHFS class code: 12:12.04.00
  • RxCUI (RxNorm): 1232651
Why two NDCs? The FDA registers this code as 31722-345-31 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 31722-0345-31. 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 alpha-1 Adrenergic Agonist class.

Pharmacologic class alpha-1 Adrenergic Agonist
Drug family (ATC) Sympathomimetics excl. antiglaucoma preparations, Adrenergic and dopaminergic agents, Other agents for treatment of hemorrhoids and anal fissures for topical use
How it works Adrenergic alpha1-Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PHENYLEPHRINE 100 MG/10 ML VL Ingredient Phenylephrine Hcl
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. The injection raises low blood pressure during anesthesia and, for some products, septic shock. Eye drops dilate the pupil, nasal products relieve conges...
  • Be careful. Over-the-counter phenylephrine should not be used with a prescription MAOI or within 2 weeks of stopping one. If you aren't sure whether your medicine is an MAOI, ask m...
  • With the injection, the most common are nausea, vomiting and headache. Call for help right away if you have chest pain, a very slow heartbeat, or pain or skin changes around the IV...
  • Stop and talk to a doctor if you get nervousness, dizziness or sleeplessness. Also stop if symptoms last more than 7 days or come with a fever. Don't use more than the label recomm...
📖 Read our full Phenylephrine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Phenylephrine Hydrochloride — tap one for details:

Butcher's BroomModerate
🌿 Every supplement checked against Phenylephrine Hydrochloride (1 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

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

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
31722-0345-10 31722-345-10 Main listing 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE 2024-05-10 — Active
31722-0345-31 You're viewing this 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE 2024-05-10 — Active

Pack size FAQ

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

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phenylephrine Hydrochloride 10 mg/mL 00641-6188-10 Hikma 10 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00641-6189-10 Hikma 10 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00781-3458-95 Sandoz 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00781-3466-70 Sandoz 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00781-9227-95 Sandoz 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00781-9228-70 Sandoz 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 14335-0441-01 Hainan 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 14335-0442-01 Hainan 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 25021-0315-01 Sagent 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 31722-0344-31 Camber 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mLthis 31722-0345-31 Camber 10 vials — AP1 FDA listed —
phenylephrine hydrochloride 10 mg/mL 36000-0360-10 Baxter 10 vials — AP1 FDA listed —
phenylephrine hydrochloride 10 mg/mL 36000-0362-05 Baxter 5 vials — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 42023-0214-10 Par 10 vials — — FDA listed —
Phenylephrine hydrochloride 10 mg/mL 42023-0215-01 Par 1 vial — — FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 55150-0301-10 Eugia 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 55150-0302-01 Eugia 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 58657-0852-11 Method 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 58657-0853-01 Method 10 ml — AP1 FDA listed —
Phenylephrine Hydrochloride 50 mg/5mL 65145-0116-01 Caplin 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 100 mg/10mL 65145-0117-01 Caplin 1 vial — AP1 FDA listed —
phenylephrine hydrochloride 10 mg/mL 68083-0338-10 Gland 10 vials — AP1 FDA listed —
phenylephrine hydrochloride 10 mg/mL 68083-0339-01 Gland 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 50 mg/5mL 70069-0802-10 Somerset 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 100 mg/10mL 70069-0803-01 Somerset 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 50 mg/5mL 70069-0812-10 Somerset 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 100 mg/10mL 70069-0813-01 Somerset 1 vial — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 70121-1578-07 Amneal 10 vials — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 70121-1579-01 Amneal 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 50 mg/5mL 70594-0064-02 Xellia 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 100 mg/10mL 70594-0065-01 Xellia 1 vial — AP1 FDA listed —
Phenylephrine hydrochloride 50 mg/5mL 70756-0622-10 Lifestar 10 vials — AP1 FDA listed —
Phenylephrine hydrochloride 100 mg/10mL 70756-0623-86 Lifestar 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71288-0808-76 Meitheal 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71839-0128-10 BE 10 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71839-0129-10 BE 10 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 72205-0265-07 Novadoz 10 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 72205-0266-07 Novadoz 10 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 50 mg/5mL 72485-0505-10 Armas 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 100 mg/10mL 72485-0506-01 Armas 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 72572-0570-10 Civica, 10 vials — AP2 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 81284-0212-10 Provepharm 10 vials — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 81284-0213-01 Provepharm 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00781-9226-92 Sandoz 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride Phenylephrine Hydrochloride 10 mg/mL 68083-0465-25 Gland 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 70069-0801-25 Somerset 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 70594-0063-02 Xellia 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 63323-0751-13 Fresenius 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 70069-0811-25 Somerset 25 vials — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 70756-0621-25 Lifestar 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71288-0807-02 Meitheal 25 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71839-0127-25 BE 25 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71872-7043-01 Medical 1 vial — AP2 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 71872-7159-01 Medical 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71872-7267-01 Medical 1 vial — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71872-7273-01 Medical 1 vial — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 71872-7303-01 Medical 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 72485-0504-25 Armas 25 vials — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 70121-1577-05 Amneal 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 72205-0264-25 Novadoz 25 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00781-3422-92 Sandoz 10 vials — AP1 FDA listed —
Biorphen 10 mg/mL 43598-0199-10 Dr. 10 ampules — — FDA listed —
Phenylephrine hydrochloride 10 mg/mL 84549-0621-25 ProPharma 1 ml — AP1 FDA listed —
phenylephrine hydrochloride 10 mg/mL 23155-0620-41 Heritage 25 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 51662-1576-01 HF 1 ml — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00404-9931-99 Henry 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 55150-0300-25 Eugia 25 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 65219-0388-01 Fresenius 25 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71872-7343-01 Medical 1 vial — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 14335-0440-01 Hainan 25 vials — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 55154-8226-05 Cardinal 5 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00641-6142-25 Hikma 25 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 65145-0115-25 Caplin 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 72572-0571-25 Civica, 25 vials — AP2 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 81284-0211-25 Provepharm 25 vials — AP1 FDA listed —
phenylephrine hydrochloride 10 mg/mL 36000-0358-25 Baxter 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 58657-0851-26 Method 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00641-6229-25 Hikma 25 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 31722-0343-32 Camber 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71872-7348-01 Medical 1 vial — AP1 FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

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

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

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

Inactive Ingredients / Excipients

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

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

  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
  • UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerCamber Pharmaceuticals, Inc.
Application holderASPIRO PHARMA LTD
FDA applicationANDA218110 (ANDA)
Labeler code31722
First marketedMay 2024
Product typeHuman Prescription Drug
Portfolio603 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 54 words ▾

1 INDICATIONS AND USAGE Phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine hydrochloride injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Phenylephrine hydrochloride injection is injected intravenously either as a bolus or in a dilute solution as a continuous infusion. Dilute before administration. ( 2 ) Dosing for treatment of hypotension during anesthesia • Bolus intravenous injection: 40 mcg to 100 mcg every 1-2 minutes as needed, not to exceed 200 mcg.

( 2 ) • Intravenous infusion: 10 mcg/min to 35 mcg/min, titrating to effect, not to exceed 200 mcg/min. ( 2 ) • Adjust the dose according to the pressor response (i.e., titrate to effect). ( 2 )

2.1General Dosage and Administration Instructions Phenylephrine hydrochloride injection must be diluted before administration as an intravenous bolus or continuous intravenous infusion to achieve the desired concentration: • Bolus : Dilute with normal saline or 5% dextrose in water. • Continuous infusion : Dilute with normal saline or 5% dextrose in water. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if the solution is colored or cloudy, or if it contains particulate matter.

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 injection administration: • Correct intravascular volume depletion. • Correct acidosis.

Acidosis may reduce the effectiveness of phenylephrine.

2.2Dosing for Treatment of Hypotension during Anesthesia The following are the recommended dosages for the treatment of hypotension during anesthesia. • The recommended initial dose is 40 to 100 mcg administered by intravenous bolus. Additional boluses may be administered every 1-2 minutes as needed; not to exceed a total dosage of 200 mcg. • If blood pressure is below the target goal, start a continuous intravenous infusion with an infusion rate of 10 to 35 mcg/minute; not to exceed 200 mcg/minute. • Adjust dosage according to the blood pressure goal.

2.3Prepare a 100 mcg/mL Solution for Bolus Intravenous Administration For bolus intravenous administration, prepare a solution containing a final concentration of 100 mcg/mL of phenylephrine hydrochloride injection: • Withdraw 10 mg (1 mL of 10 mg/mL) of phenylephrine hydrochloride injection and dilute with 99 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. • Withdraw an appropriate dose from the 100 mcg/mL solution prior to bolus intravenous administration.

2.4Prepare a Solution for Continuous Intravenous Administration For continuous intravenous infusion, prepare a solution containing a final concentration of 20 mcg/mL of phenylephrine hydrochloride injection in 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP: • Withdraw 10 mg (1 mL of 10 mg/mL) of phenylephrine hydrochloride injection and dilute with 500 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP.

2.5Directions for Dispensing from Pharmacy Bulk Vial The Pharmacy Bulk Vial is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion. Each closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. The Pharmacy Bulk Vial is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).

Dispensing from a pharmacy bulk vial should be completed within 4 hours after the vial is penetrated.

💊 Dosage Forms and Strengths 160 words ▾

3 DOSAGE FORMS AND STRENGTHS Phenylephrine hydrochloride injection, USP 10 mg/mL, for intravenous use, is available in three vial sizes: • Injection: 10 mg/mL as a sterile, clear, colorless solution in a single-dose 1 mL vial (10 mg of phenylephrine hydrochloride per vial) • Injection: 10 mg/mL as a sterile, clear, colorless solution in Pharmacy Bulk Package 5 mL vial (50 mg of phenylephrine hydrochloride per vial) that will provide five 1 mL single doses • Injection: 10 mg/mL as a sterile, clear, colorless solution in Pharmacy Bulk Package 10 mL vial (100 mg of phenylephrine hydrochloride per vial) that will provide ten 1 mL single doses Injection ( 3 ) • 1 mL single-dose vials containing 10 mg phenylephrine hydrochloride (10 mg/mL) ( 3 ) • 5 mL pharmacy bulk package vials containing 50 mg phenylephrine hydrochloride (10 mg/mL) ( 3 ) • 10 mL pharmacy bulk package vials containing 100 mg phenylephrine hydrochloride (10 mg/mL) ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None None ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension: Phenylephrine hydrochloride can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure. ( 5.1 ) Peripheral and Visceral Ischemia: Phenylephrine hydrochloride can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs. ( 5.2 ) Skin and Subcutaneous Necrosis: Extravasation during intravenous administration may cause necrosis or sloughing of tissue.

( 5.3 ) Bradycardia: Phenylephrine hydrochloride can cause severe bradycardia and decreased cardiac output. ( 5.4 )

5.1Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension Because of its increasing blood pressure effects, phenylephrine hydrochloride can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.

5.2Peripheral 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.

5.3Skin and Subcutaneous Necrosis Extravasation of phenylephrine hydrochloride can cause necrosis or sloughing of tissue. The infusion site should be checked for free flow. Care should be taken to avoid extravasation of phenylephrine hydrochloride.

5.4Bradycardia Phenylephrine hydrochloride can cause severe bradycardia and decreased cardiac output.

5.5Allergic Reactions Phenylephrine hydrochloride 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.

5.6Renal Toxicity Phenylephrine hydrochloride can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function.

5.7Risk of Augmented Pressor Affect in Patients with Autonomic Dysfunction The increasing blood pressure response to adrenergic drugs, including phenylephrine hydrochloride, can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries.

5.8Pressor Effect with Concomitant Oxytocic Drugs Oxytocic drugs potentiate the increasing blood pressure effect of sympathomimetic pressor amines including phenylephrine hydrochloride [see Drug Interactions ( 7.1 )] , with the potential for hemorrhagic stroke.

🤒 Adverse Reactions 145 words ▾

6 ADVERSE REACTIONS Adverse reactions to phenylephrine hydrochloride are primarily attributable to excessive pharmacologic activity. Adverse reactions reported in published clinical studies, observational trials, and case reports of phenylephrine hydrochloride are listed below by body system. 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 : Reflex bradycardia, lowered cardiac output, ischemia, hypertension, arrhythmias Gastrointestinal disorders : Epigastric pain, vomiting, nausea Nervous system disorders : Headache, blurred vision, neck pain, tremors Vascular disorders : Hypertensive crisis Respiratory, Thoracic and Mediastinal Disorders : Dyspnea Skin and subcutaneous tissue disorders : Pruritis Most common adverse reactions during treatment: nausea, vomiting, and headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aspiro Pharma Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 186 words ▾

7 DRUG INTERACTIONS Agonistic effects (increase in phenylephrine hydrochloride blood pressure effect) can occur with monoamine oxidase inhibitors (MAOI), oxytocin and oxytocic drugs, tricyclic antidepressants, angiotensin and aldosterone, atropine, steroids, norepinephrine transporter inhibitors, ergot alkaloids. ( 7.1 ) Antagonistic effects (decrease in phenylephrine hydrochloride blood pressure effect) can occur with α-adrenergic antagonists, phosphodiesterase Type 5 inhibitors, mixed α- and β-receptor antagonists, calcium channel blockers, benzodiazepines and ACE inhibitors, centrally acting sympatholytic agents.

( 7.2 )

7.1Interactions that Augment Pressor Effect The increasing blood pressure effect of phenylephrine hydrochloride is increased in patients receiving: • Monoamine oxidase inhibitors (MAOI) • Oxytocin and oxytocic drugs • Tricyclic antidepressants • Angiotensin, aldosterone • Atropine • Steroids, such as hydrocortisone • Norepinephrine transporter inhibitors, such as atomoxetine • Ergot alkaloids, such as methylergonovine maleate

7.2Interactions that Antagonize the Pressor Effect The increasing blood pressure effect of phenylephrine hydrochloride is decreased in patients receiving: • α-adrenergic antagonists • Phosphodiesterase Type 5 inhibitors • Mixed α- and β-receptor antagonists • Calcium channel blockers, such as nifedipine • Benzodiazepines • ACE inhibitors • Centrally acting sympatholytic agents, such as reserpine, guanfacine

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during Cesarean section have not established a drug-associated risk of major birth defects and miscarriage. These studies have not identified an adverse effect on maternal outcomes or infant Apgar scores [see Data] . There are no data on the use of phenylephrine during the first or second trimester.

In animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times the human daily dose (HDD) of 10 mg/60 kg/day. Decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the HDD [See Data] . The estimated background risk of major birth defects and miscarriage for the indicated population are unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk Untreated hypotension associated with spinal anesthesia for Cesarean section is associated with an increase in maternal nausea and vomiting.

A sustained decrease in uterine blood flow due to maternal hypotension may result in fetal bradycardia and acidosis. Data Human Data Published randomized controlled trials over several decades, which compared the use of phenylephrine injection to other similar agents in pregnant women during Cesarean section, have not identified adverse maternal or infant outcomes. At recommended doses, phenylephrine does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree.

There are no studies on the safety of phenylephrine injection exposure during the period of organogenesis, and therefore, it is not possible to draw any conclusions on the risk of birth defects following exposure to phenylephrine injection during pregnancy. In addition, there are no data on the risk of miscarriage following fetal exposure to phenylephrine injection. Animal Data No clear malformations or fetal toxicity were reported when normotensive pregnant rabbits were treated with phenylephrine via continuous intravenous infusion over 1 hour (0.5 mg/kg/day; approximately equivalent to a HDD based on body surface area) from Gestation Day 7 to 19.

At this dose, which demonstrated no maternal toxicity, there was evidence of developmental delay (altered ossification of sternebra). In a non-GLP dose range-finding study in normotensive pregnant rabbits, fetal lethality and cranial, paw, and limb malformations were noted following treatment with 1.2 mg/kg/day of phenylephrine via continuous intravenous infusion over 1 hour (2.3-times the HDD). This dose was clearly maternally toxic (increased mortality and significant body weight loss).

An increase in the incidence of limb malformation (hyperextension of the forepaw) coincident with high fetal mortality was noted in a single litter at 0.6 mg/kg/day (1.2-times the HDD) in the absence of maternal toxicity. No malformations or embryo-fetal toxicity were reported when normotensive pregnant rats were treated with up to 3 mg/kg/day phenylephrine via continuous intravenous infusion over 1 hour (2.9-times the HDD) from Gestation Day 6 to 17. This dose was associated with some maternal toxicity (decreased food consumption and body weights).

Decreased pup weights were reported in a pre- and postnatal development toxicity study in which normotensive pregnant rats were administered phenylephrine via continuous intravenous infusion over 1 hour (0.3, 1.0, or 3.0 mg/kg/day; 0.29, 1, or 2.9 times the HDD) from Gestation Day 6 through Lactation Day 21). No adverse effects on growth and development (lea… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during Cesarean section have not established a drug-associated risk of major birth defects and miscarriage. These studies have not identified an adverse effect on maternal outcomes or infant Apgar scores [see Data] . There are no data on the use of phenylephrine during the first or second trimester.

In animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times the human daily dose (HDD) of 10 mg/60 kg/day. Decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the HDD [See Data] . The estimated background risk of major birth defects and miscarriage for the indicated population are unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk Untreated hypotension associated with spinal anesthesia for Cesarean section is associated with an increase in maternal nausea and vomiting.

A sustained decrease in uterine blood flow due to maternal hypotension may result in fetal bradycardia and acidosis. Data Human Data Published randomized controlled trials over several decades, which compared the use of phenylephrine injection to other similar agents in pregnant women during Cesarean section, have not identified adverse maternal or infant outcomes. At recommended doses, phenylephrine does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree.

There are no studies on the safety of phenylephrine injection exposure during the period of organogenesis, and therefore, it is not possible to draw any conclusions on the risk of birth defects following exposure to phenylephrine injection during pregnancy. In addition, there are no data on the risk of miscarriage following fetal exposure to phenylephrine injection. Animal Data No clear malformations or fetal toxicity were reported when normotensive pregnant rabbits were treated with phenylephrine via continuous intravenous infusion over 1 hour (0.5 mg/kg/day; approximately equivalent to a HDD based on body surface area) from Gestation Day 7 to 19.

At this dose, which demonstrated no maternal toxicity, there was evidence of developmental delay (altered ossification of sternebra). In a non-GLP dose range-finding study in normotensive pregnant rabbits, fetal lethality and cranial, paw, and limb malformations were noted following treatment with 1.2 mg/kg/day of phenylephrine via continuous intravenous infusion over 1 hour (2.3-times the HDD). This dose was clearly maternally toxic (increased mortality and significant body weight loss).

An increase in the incidence of limb malformation (hyperextension of the forepaw) coincident with high fetal mortality was noted in a single litter at 0.6 mg/kg/day (1.2-times the HDD) in the absence of maternal toxicity. No malformations or embryo-fetal toxicity were reported when normotensive pregnant rats were treated with up to 3 mg/kg/day phenylephrine via continuous intravenous infusion over 1 hour (2.9-times the HDD) from Gestation Day 6 to 17. This dose was associated with some maternal toxicity (decreased food consumption and body weights).

Decreased pup weights were reported in a pre- and postnatal development toxicity study in which normotensive pregnant rats were administered phenylephrine via continuous intravenous infusion over 1 hour (0.3, 1.0, or 3.0 mg/kg/day; 0.29, 1, or 2.9 times the HDD) from Gestation Day 6 through Lactation Day 21). No adverse effects on growth and development (learning and memory, sexual devel… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 83 words ▾

8.5Geriatric 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.

🆘 Overdosage 43 words ▾

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

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Phenylephrine hydrochloride is an α-1 adrenergic receptor agonist.

12.2Pharmacodynamics Interaction of phenylephrine with α-1 adrenergic receptors on vascular smooth muscle cells causes activation of the cells and results in vasoconstriction. Following phenylephrine hydrochloride intravenous administration, increases in systolic and diastolic blood pressures, 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, typically within minutes.

As blood pressure increases following intravenous administration, vagal activity also increases, resulting in reflex bradycardia. Phenylephrine has activity on most vascular beds, including renal, pulmonary, and splanchnic arteries.

12.3Pharmacokinetics Following an intravenous infusion of phenylephrine hydrochloride, the observed effective halflife was approximately 5 minutes. The steady-state volume of distribution of approximately 340 L suggests a high distribution into organs and peripheral tissues. The average total serum clearance is approximately 2100 mL/min.

The observed phenylephrine plasma terminal elimination half-life was 2.5 hours. Phenylephrine is metabolized primarily by monoamine oxidase and sulfotransferase. After intravenous administration of radiolabeled phenylephrine, approximately 80% of the total dose was eliminated within first 12 h; and approximately 86% of the total dose was recovered in the urine within 48 h.

The excreted unchanged parent drug was 16% of the total dose in the urine at 48 h post intravenous administration. There are two major metabolites, with approximately 57 and 8% of the total dose excreted as m -hydroxymandelic acid and sulfate conjugates, respectively. The metabolites are considered not pharmacologically active.

🧬 Mechanism of Action 12 words ▾

12.1Mechanism of Action Phenylephrine hydrochloride is an α-1 adrenergic receptor agonist.

📦 How Supplied / Storage and Handling 190 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Phenylephrine hydrochloride injection, USP 10 mg/mL, is a sterile, clear, colorless solution supplied as follows: NDC No. Strength How Supplied 31722-343-32 10 mg/mL 1 mL single dose vial (supplied in packages of 10) 31722-343-33 10 mg/mL 1 mL single dose vial (supplied in packages of 25) 31722-344-31 50 mg/5 mL 5 mL vial; Pharmacy Bulk Package (supplied in packages of 10) 31722-345-10 100 mg/10 mL 10 mL vial; Pharmacy Bulk Package (supplied in packages of 1) 31722-345-31 100 mg/10 mL 10 mL vial; Pharmacy Bulk Package (supplied in packages of 10) Vial stoppers are not manufactured with natural rubber latex.

Store phenylephrine hydrochloride injection USP, 10 mg/mL at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in carton until time of use.

The 1 mL vials are for single use only; the 5 and 10 mL vials are pharmacy bulk packages. 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.

📋 Description 143 words ▾

11 DESCRIPTION Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine hydrochloride injection, 10 mg/mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion.

The chemical name of phenylephrine hydrochloride is (-)-m-hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C 9 H 14 ClNO 2 with a molecular weight of 203.67. Its structural formula is depicted below: Phenylephrine hydrochloride, USP is a white or practically white, odorless powder. It is freely soluble in water, alcohol and glycerol.

Each mL contains: Phenylephrine hydrochloride USP 10 mg, citric acid monohydrate 1 mg, sodium chloride 3.5 mg, sodium metabisulfite 2 mg, and tri sodium citrate dihydrate 4 mg in water for injection. The pH is adjusted with hydrochloric acid and/or sodium hydroxide if necessary. The pH range is 3.5 to 5.5. aspirologo

💬 Information for Patients 56 words ▾

17 PATIENT COUNSELING INFORMATION If applicable, inform patient, family member, or caregiver that certain medical conditions and medications might influence how phenylephrine hydrochloride injection works. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854. Manufactured by: Aspiro Pharma Limited Survey No. 321, Biotech Park, Phase – III Karkapatla Village, Markook (Mandal) Siddipet, Telangana-502281, India. Issued: 07/2024 aspirologo

🧬 Pharmacokinetics 146 words ▾

12.3Pharmacokinetics Following an intravenous infusion of phenylephrine hydrochloride, the observed effective halflife was approximately 5 minutes. The steady-state volume of distribution of approximately 340 L suggests a high distribution into organs and peripheral tissues. The average total serum clearance is approximately 2100 mL/min.

The observed phenylephrine plasma terminal elimination half-life was 2.5 hours. Phenylephrine is metabolized primarily by monoamine oxidase and sulfotransferase. After intravenous administration of radiolabeled phenylephrine, approximately 80% of the total dose was eliminated within first 12 h; and approximately 86% of the total dose was recovered in the urine within 48 h.

The excreted unchanged parent drug was 16% of the total dose in the urine at 48 h post intravenous administration. There are two major metabolites, with approximately 57 and 8% of the total dose excreted as m -hydroxymandelic acid and sulfate conjugates, respectively. The metabolites are considered not pharmacologically active.

🧬 Pharmacodynamics 92 words ▾

12.2Pharmacodynamics Interaction of phenylephrine with α-1 adrenergic receptors on vascular smooth muscle cells causes activation of the cells and results in vasoconstriction. Following phenylephrine hydrochloride intravenous administration, increases in systolic and diastolic blood pressures, 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, typically within minutes.

As blood pressure increases following intravenous administration, vagal activity also increases, resulting in reflex bradycardia. Phenylephrine has activity on most vascular beds, including renal, pulmonary, and splanchnic arteries.

🔬 Clinical Studies 112 words ▾

14 CLINICAL STUDIES The evidence for the efficacy of phenylephrine hydrochloride is derived from studies of phenylephrine hydrochloride in the published literature. The literature support includes 16 studies evaluating the use of intravenous phenylephrine to treat hypotension during anesthesia. The 16 studies include 9 studies where phenylephrine was used in low-risk (ASA 1 and 2) pregnant women undergoing neuraxial anesthesia during Cesarean delivery, 6 studies in non-obstetric surgery under general anesthesia, and 1 study in non-obstetric surgery under combined general and neuraxial anesthesia.

Phenylephrine has been shown to raise systolic and mean blood pressure when administered either as a bolus dose or by continuous infusion following the development of hypotension during anesthesia.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies that evaluated the carcinogenic potential of orally administered phenylephrine hydrochloride in F344/N rats and B6C3F 1 mice were completed by the National Toxicology Program using the dietary route of administration. There was no evidence of carcinogenicity in mice administered approximately 270 mg/kg/day (131 times the human daily dose (HDD) of 10 mg/60 kg/day based on body surface area) or rats administered approximately 50 mg/kg/day (48 times HDD) based on body surface area comparisons.

Mutagenesis Phenylephrine hydrochloride tested negative in the in vitro bacterial reverse mutation assay ( S . typhimurium strains TA98, TA100, TA1535 and TA1537), the in vitro chromosomal aberrations assay, the in vitro sister chromatid exchange assay, and the in vivo rat micronucleus assay. Positive results were reported in only one of two replicates of the in vitro mouse lymphoma assay. Impairment of Fertility Phenylephrine did not impair mating, fertility, or reproductive outcome in normotensive male rats treated with 3 mg/kg/day phenylephrine via continuous intravenous infusion over 1 hour (2.9 times the HDD) for 28 days prior to mating and for a minimum of 63 days prior to sacrifice and female rats treated with the same dosing regimen for 14 days prior to mating and through Gestation Day 6.

This dose was associated with increased mortality in both male and female rats and decreased body weight gain in treated males. There were decreased caudal sperm density and increased abnormal sperm reported in males treated with 3 mg/kg/day phenylephrine (2.9 times the HDD).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies that evaluated the carcinogenic potential of orally administered phenylephrine hydrochloride in F344/N rats and B6C3F 1 mice were completed by the National Toxicology Program using the dietary route of administration. There was no evidence of carcinogenicity in mice administered approximately 270 mg/kg/day (131 times the human daily dose (HDD) of 10 mg/60 kg/day based on body surface area) or rats administered approximately 50 mg/kg/day (48 times HDD) based on body surface area comparisons.

Mutagenesis Phenylephrine hydrochloride tested negative in the in vitro bacterial reverse mutation assay ( S . typhimurium strains TA98, TA100, TA1535 and TA1537), the in vitro chromosomal aberrations assay, the in vitro sister chromatid exchange assay, and the in vivo rat micronucleus assay. Positive results were reported in only one of two replicates of the in vitro mouse lymphoma assay. Impairment of Fertility Phenylephrine did not impair mating, fertility, or reproductive outcome in normotensive male rats treated with 3 mg/kg/day phenylephrine via continuous intravenous infusion over 1 hour (2.9 times the HDD) for 28 days prior to mating and for a minimum of 63 days prior to sacrifice and female rats treated with the same dosing regimen for 14 days prior to mating and through Gestation Day 6.

This dose was associated with increased mortality in both male and female rats and decreased body weight gain in treated males. There were decreased caudal sperm density and increased abnormal sperm reported in males treated with 3 mg/kg/day phenylephrine (2.9 times the HDD).

📄 Package Label / Principal Display Panel 65 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Phenylephrine Hydrochloride Injection, USP 10 mg/mL container label Phenylephrine Hydrochloride Injection, USP 10 mg/mL 10s carton label Phenylephrine Hydrochloride Injection, USP 50 mg/5 mL container label Phenylephrine Hydrochloride Injection, USP 50 mg/5 mL 10s carton label Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL container label Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL 1s carton label phenylephrinehcl10mgcontainerlabel phenylephrinehcl10mg10scartoblabel phenylephrinehcl50mgcontainerlabel phenylephrinehcl50mg10scartonlabel phenylephrinehcl100mgcontainerlabel phenylephrinehcl100mg1scartonlabel

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PHENYLEPHRINE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Fatigue17,479
Headache14,275
Pain14,233
Nausea14,023
Diarrhoea11,944
Arthralgia11,112
Dyspnoea10,803

Age at onset

Neonate113
Infant504
Child1,107
Adolescent638
Adult16,345
Elderly12,489

Reporter sex

168,585 reports
Male · 31%
Female · 69%
Unknown · 0%

Serious outcomes

Hospitalization43,935
Death13,703
Disabling6,802
Life-threatening6,546
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 15,951 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 ✓ Available
Inactive ingredients (structured) ✓ 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 ✓ Available
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 Camber Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (31722-0345-10). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Camber Pharmaceuticals, 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.
← 31722-0344-31 · Camber 31722-0350-01 · Camber →
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.