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PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL Injection

by Meitheal Pharmaceuticals Inc. · 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-808-76) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (71288-808-75)
NDC 71288-0808-76
🏷️ FDA NDC (as labeled) 71288-808-76 billing pads the product segment with a zero
This package
Contains5 mL in 1 vial, pharmacy bulk package Medicaid pays$1.70 / unit · 12 mo Per package$16.97 / 10 vials · Medicaid Pack sizes2 compare ↓
Also comes in: 10 mL 71288-0808-77
Rx only Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 71288-808-76
Product NDC 71288-808
11-digit billing NDC 71288080876
NCPDP billing unit ML — per mL (volume)
RxCUI 1232651
UNII 04JA59TNSJ
Application # ANDA210333
SPL Set ID 943638b7-527b-4724-a6b7-2018862396d4
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 2018-04-27
Route INTRAVENOUS
Dosage form INJECTION
Substance PHENYLEPHRINE HYDROCHLORIDE
GPI-14 38000095102020
GPI class Phenylephrine HCl
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 50 MG/5 ML VIAL
FDB brand name Phenylephrine Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP1 · RLD · RS
Why two NDCs? The FDA registers this code as 71288-808-76 — 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 → 71288-0808-76. 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.

🏭 Manufacturer & labeler

LabelerMeitheal Pharmaceuticals Inc.
Application holderMEITHEAL PHARMACEUTICALS INC
FDA applicationANDA210333 (ANDA)
Labeler code71288
First marketedApr 2018
Product typeHuman Prescription Drug
Portfolio158 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PHENYLEPHRINE 50 MG/5 ML VIAL Ingredient Phenylephrine Hcl
📗 Our plain-language guide HelloPharmacist
  • Yes, it's the same active ingredient, but used in very different ways depending on the form. The nasal spray delivers a tiny amount directly to the nasal lining to temporarily shri...
  • I see phenylephrine in nasal sprays at the pharmacy AND as an IV drug in the hospital — is it really the same medication?
  • You should check with your doctor first. Phenylephrine constricts blood vessels, which can raise blood pressure and put extra strain on the heart — even from a nasal spray. If you...
  • Can I use the nasal spray if I have high blood pressure or heart disease?
📖 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.

🧪 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.

💲 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 $1.70 $16.97 / 10 vials
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2371 $0.002 / J2371 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)71288-808-76
11-digit billing NDC71288-0808-76
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2371
DescriptorINJECTION, PHENYLEPHRINE HYDROCHLORIDE, 20 MICROGRAMS
Billing units / pkg500 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phenylephrine Hydrochloride 10 mg/mL 00641-6188-10 Hikma 10 vials — — FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00641-6189-10 Hikma 10 vials — — 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/mL 31722-0345-10 Camber 1 vial — 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/mLthis 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 — — 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 — — 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 — AP 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 — — 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 — — 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 — — 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

🏛️
2018
On the market since
Apr 2018
📍
2026
Currently FDA-listed
8 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 71288-0808-76, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
11
Units reimbursed last 4 qtrs
6
Gross reimbursed last 4 qtrs
$10.18
Avg / prescription
$0.93
Avg / unit
$1.6967
Latest quarter Q4 2025
0Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 11 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 6 units · 0.1 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.10.1
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Minnesota 0.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
10 vials this page71288-0808-76 11 Rx · $10
1 vial71288-0808-77 No Medicaid data
Drug total (last 4 qtrs): 11 Rx · 6 units · $10 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71288-0808-76 You're viewing this 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-808-76) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (71288-808-75) 2018-04-27 Active
71288-0808-77 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-808-77) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE 2018-04-27 Active

Pack size FAQ

What quantity is in NDC 71288-0808-76?
NDC 71288-0808-76 is listed by the FDA — 10 vial, pharmacy bulk package in 1 carton / 5 ml in 1 vial, pharmacy bulk package.
What NDC number is used to bill for this package of PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL Injection?
Bill NDC 71288-0808-76 — the 11-digit billing format is 71288080876. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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 FDA registers it as 71288-808-76, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71288-0808-76, written without dashes as 71288080876. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71288-0808-76, the first segment (71288) is the labeler code FDA assigned to Meitheal Pharmaceuticals Inc.; the middle segment (0808) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (76) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Meitheal 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 (71288-0808-77). 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?
Meitheal 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2371 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 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
🎯 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, 10 mg per mL, 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 per mL Solution for Bolus Intravenous Administration For bolus intravenous administration, prepare a solution containing a final concentration of 100 mcg per mL of phenylephrine hydrochloride injection: Withdraw 10 mg (1 mL of 10 mg per 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 per 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 per 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 per 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 126 words ▾

3 DOSAGE FORMS AND STRENGTHS Phenylephrine Hydrochloride Injection, USP 10 mg per mL, for intravenous use, is available in two vial sizes: Injection: 10 mg per mL as a 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 per mL as a 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 ) 5 mL pharmacy bulk package vials containing 50 mg phenylephrine hydrochloride (10 mg per mL) ( 3 ) 10 mL pharmacy bulk package vials containing 100 mg phenylephrine hydrochloride (10 mg per 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 injection.

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

5.5Allergic Reactions Phenylephrine hydrochloride injection 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 139 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 Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 171 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 hydrochloride during the first or second trimester.

In animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine hydrochloride 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 hydrochloride injection to other similar agents in pregnant women during Cesarean section, have not identified adverse maternal or infant outcomes. At recommended doses, phenylephrine hydrochloride 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 hydrochloride 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 hydrochloride injection during pregnancy. In addition, there are no data on the risk of miscarriage following fetal exposure to phenylephrine hydrochloride injection. Animal Data No clear malformations or fetal toxicity were reported when normotensive pregnant rabbits were treated with phenylephrine hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride via continuous intravenous infusion over 1 hour (0…

🤰 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 hydrochloride during the first or second trimester.

In animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine hydrochloride 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 hydrochloride injection to other similar agents in pregnant women during Cesarean section, have not identified adverse maternal or infant outcomes. At recommended doses, phenylephrine hydrochloride 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 hydrochloride 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 hydrochloride injection during pregnancy. In addition, there are no data on the risk of miscarriage following fetal exposure to phenylephrine hydrochloride injection. Animal Data No clear malformations or fetal toxicity were reported when normotensive pregnant rabbits were treated with phenylephrine hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride via continuous intravenous infusion over 1 hour (0.3, 1.0, or 3.0 mg/kg/day; 0.2…

🧒 Pediatric Use 13 words ▾

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

🧓 Geriatric Use 84 words ▾

8.5Geriatric Use Clinical studies of phenylephrine hydrochloride 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 hydrochloride 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 hydrochloride has activity on most vascular beds, including renal, pulmonary, and splanchnic arteries.

12.3Pharmacokinetics Following an intravenous infusion of phenylephrine hydrochloride, the observed effective half-life 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 hydrochloride plasma terminal elimination half-life was 2.5 hours. Phenylephrine hydrochloride is metabolized primarily by monoamine oxidase and sulfotransferase. After intravenous administration of radiolabeled phenylephrine hydrochloride, 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 134 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Phenylephrine Hydrochloride Injection, USP, 10 mg per mL, is a clear, colorless solution supplied as follows: NDC Phenylephrine Hydrochloride Injection, USP (10 mg per mL) Package Factor 71288- 808 -76 50 mg per 5 mL Pharmacy Bulk Package 10 vials per carton 71288- 808 -77 100 mg per 10 mL Pharmacy Bulk Package 1 vial per carton Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature]. Protect from light. Store in carton until time of use.

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. Sterile, Nonpyrogenic.

The container closure is not made with natural rubber latex.

📋 Description 160 words ▾

11 DESCRIPTION Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine Hydrochloride Injection, USP 10 mg per mL, is a 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 203.66 g/mol. Its structural formula is depicted below: Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine Hydrochloride Injection, USP, 10 mg per mL, is a clear, colorless solution and is sensitive to light.

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

Structural Formula

💬 Information for Patients 41 words ▾

17 PATIENT COUNSELING INFORMATION If applicable, inform patient, family member, or caregiver that certain medical conditions and medications might influence how phenylephrine hydrochloride works. meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2020 Meitheal Pharmaceuticals Inc. November 2020 810044-01

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71288-0807-02 · Meitheal 71288-0811-11 · Meitheal →
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.