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Phenylephrine Hydrochloride 10 mg/mL Injection — NDC 00641-6189-10 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 0641-6189-10 (Billing 00641-6189-10)

by Hikma Pharmaceuticals USA 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 Hikma Pharmaceuticals USA Inc., marketed since Jun 2019 and currently FDA-listed. It is this product's only package size.

NDC 00641-6189-10
🏷️ FDA NDC (as labeled) 0641-6189-10 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 3, 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) 0641-6189-10
Product NDC 0641-6189
11-digit billing NDC 00641618910
NCPDP billing unit ML — per mL (volume)
RxCUI 1232651, 1666372, 2262018, 2634228, 2634233, 2634235
UNII 04JA59TNSJ
UPC 0306416188104
Application # NDA203826
SPL Set ID e1a7ab4b-0afe-4463-a039-5be0323cf2f7
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-06-19
Route INTRAVENOUS
Dosage form INJECTION
Substance PHENYLEPHRINE HYDROCHLORIDE
TE code (Orange Book) AP2 · 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 0641-6189-10 — a 4-4-2 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 labeler segment → 00641-6189-10. 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.
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)0641-6189-10
11-digit billing NDC00641-6189-10
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ2371
DescriptorINJECTION, PHENYLEPHRINE HYDROCHLORIDE, 20 MICROGRAMS
Billing units / pkg500 units
How the units are derivedThis package is 10 ML; the HCPCS unit is 20 MCG, so one package = 500 billing units.
Medicare Part B spend (2026 (Q1))$335 · 99 claims · $3.38 per claim (all NDCs under J2371)
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00641-6189-10 You're viewing this Main listing 10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE 2019-06-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phenylephrine Hydrochloride 10 mg/mL 00641-6188-10 Hikma 10 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mLthis 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/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/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 the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
First FDA approval
Mar 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2036
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2036. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 9, 2023 RLD RS ⏳ ~10 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11213480 — drug product
US 11471400 — drug product
US 11213480 — drug product
US 12257342 — drug product
US 11471400 — drug product
US 12257342 — drug product
2023 2025 2027 2029 2031 2033 2035
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (6)
PatentTypeUse codeExpires
US 11213480 ↗ Drug product — Sep 26, 2036
US 11471400 ↗ Drug product — Aug 5, 2036
US 11213480 ↗ Drug product — Sep 26, 2036
US 12257342 ↗ Drug product — Sep 26, 2036
US 11471400 ↗ Drug product — Aug 5, 2036
US 12257342 ↗ Drug product — Sep 26, 2036
Common questions
Is there a generic version of PHENYLEPHRINE 100 MG/10 ML VL?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for PHENYLEPHRINE 100 MG/10 ML VL. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

  • 1 mg / 1 mL 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.
  • 3.5 mg / 1 mL 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.
  • 2 mg / 1 mL 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.
  • 4 mg / 1 mL 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

LabelerHikma Pharmaceuticals USA Inc.
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationNDA203826 (NDA)
Labeler code00641
First marketedJun 2019
Product typeHuman Prescription Drug
Portfolio726 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. 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 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 121 words ▾

1 INDICATIONS AND USAGE IMMPHENTIV injection 100 mcg/mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine Hydrochloride Injection 10 mg/mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock. IMMPHENTIV injection 100 mcg/mL is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

Phenylephrine Hydrochloride Injection 10 mg/mL is alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION IMMPHENTIV Injection 100 mcg/mL: Do NOT dilute prior to administration ( 2.1 ) Dosing for Perioperative Hypotension - Intravenous bolus administration: 50 mcg to 250 mcg ( 2.2 ) Phenylephrine Hydrochloride Injection 10 mg/mL: MUST BE DILUTED before administration. ( 2.1 ) Dosing for Perioperative Hypotension Intravenous bolus administration: 50 mcg to 250 mcg ( 2.2 ) Intravenous continuous infusion: 0.5 mcg/kg/minute to 1.4 mcg/kg/minute titrated to effect ( 2.2 ) Dosing for Patients with Vasodilatory Shock Intravenous continuous infusion: 0.5 mcg/kg/minute to 6 mcg/kg/minute titrated to effect ( 2.2 )

2.1General Administration Instructions Phenylephrine Hydrochloride Injection is injected by bolus intravenous infusion or in dilute solution as a continuous intravenous infusion.

2.2Preparation of Phenylephrine Hydrochloride Injection Preparing a 100 mcg/mL Solution for Intravenous Bolus Administration For intravenous bolus administration, withdraw 10 mg (1 mL of a 10 mg/mL concentration) of Phenylephrine Hydrochloride Injection 10 mg/mL and dilute with 99 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. This will yield a final concentration of 100 mcg/mL. Withdraw an appropriate dose from the 100 mcg/mL solution prior to intravenous bolus administration.

Preparing a 20 mcg/mL Solution for Continuous Intravenous Infusion For continuous intravenous infusion, withdraw 10 mg (1 mL of 10 mg/mL concentration) of phenylephrine hydrochloride injection 10 mg/mL and add to 500 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (providing a final concentration of 20 mcg/mL). Directions for Dispensing from Phenylephrine Hydrochloride Injection 10 mg/mL 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.

Dosing for Perioperative Setting In adult patients undergoing surgical procedures with either neuraxial anesthesia or general anesthesia: IMMPHENTIV Injection 100 mcg/mL and Phenylephrine Hydrochloride Injection 10 mg/mL (diluted to 100 mcg/mL): 50 mcg to 250 mcg by intravenous bolus administration. The most frequently reported initial bolus dose is 50 mcg or 100 mcg. Phenylephrine Hydrochloride Injection 10 mg/mL (diluted to 20 mcg/mL): 0.5 mcg/kg/min to 1.4 mcg/kg/min by intravenous continuous infusion, titrated to blood pressure goal.

Dosing for Septic or Other Vasodilatory Shock (Phenylephrine Hydrochloride Injection 10 mg/mL only) In adult patients with septic or other vasodilatory shock: No bolus. 0.5 mcg/kg/min to 6 mcg/kg/min by intravenous continuous infusion, titrated to blood pressure goal. Doses above 6 mcg/kg/min do not show significant incremental increase in blood pressure.

💊 Dosage Forms and Strengths ~1 min read ▾

3 DOSAGE FORMS AND STRENGTHS IMMPHENTIV ® injection, USP: 100 mcg/mL phenylephrine hydrochloride is a clear, colorless, essentially free of visible foreign matter sterile parenteral solution, available in two vial sizes: 500 mcg in 5 mL (100 mcg/mL) of Phenylephrine hydrochloride in a single-dose Ready-To-Use vial 1,000 mcg in 10 mL (100 mcg/mL) of Phenylephrine hydrochloride in a single-dose Ready-To-Use vial Phenylephrine Hydrochloride Injection, USP: 10 mg/mL phenylephrine hydrochloride is a clear, colorless, essentially free of visible foreign matter sterile parenteral solution, available in three vial sizes: 10 mg in 1 mL (10 mg/mL) of Phenylephrine hydrochloride in a single-dose vial 50 mg in 5 mL (10 mg/mL) of Phenylephrine hydrochloride in a pharmacy bulk package vial 100 mg in 10 mL (10 mg/mL) of Phenylephrine hydrochloride in a pharmacy bulk package vial IMMPHENTIV ® Injection : 500 mcg in 5 mL (100 mcg/mL) of Phenylephrine hydrochloride in a single-dose Ready-To-Use vial ( 3 ) 1,000 mcg in 10 mL (100 mcg/mL) of Phenylephrine hydrochloride in a single-dose Ready-To-Use vial ( 3 ) Phenylephrine Hydrochloride Injection : 10 mg in 1 mL (10 mg/mL) of Phenylephrine hydrochloride in a single-dose vial ( 3 ) 50 mg in 5 mL (10 mg/mL) of Phenylephrine hydrochloride in a pharmacy bulk package vial ( 3 ) 100 mg in 10 mL (10 mg/mL) of Phenylephrine hydrochloride in a pharmacy bulk package vial ( 3 )

⛔ Contraindications 40 words ▾

4 CONTRAINDICATIONS The use of IMMPHENTIV 100 mcg/mL and Phenylephrine Hydrochloride Injection 10 mg/mL is contraindicated in patients with: Hypersensitivity to the products or any of their components Hypersensitivity to the products or any of their components ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Severe bradycardia and decreased cardiac output : ( 5.2 ) Extravasation : during intravenous administration may cause necrosis or sloughing of tissue ( 5.4 ) Concomitant use with oxytocic drugs : pressor effect of sympathomimetic pressor amines is potentiated ( 5.5 ) Allergic-type reactions with Phenylephrine Hydrochloride Injection 10 mg/mL : Sulfite ( 5.6 )

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

5.2Bradycardia IMMPHENTIV 100 mcg/mL and Phenylephrine Hydrochloride Injection 10 mg/mL can cause severe bradycardia and decreased cardiac output.

5.3Risk in Patients with Autonomic Dysfunction The pressor response to adrenergic drugs, including phenylephrine, can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries.

5.4Skin and Subcutaneous Necrosis Extravasation of phenylephrine can cause necrosis or sloughing of tissue.

5.5Pressor Effect with Concomitant Oxytocic Drugs Oxytocic drugs potentiate the pressor effect of sympathomimetic pressor amines including IMMPHENTIV 100 mcg/mL and Phenylephrine Hydrochloride Injection 10 mg/mL [see Drug Interactions (7.1) ] , with the potential for hemorrhagic stroke.

5.6Allergic Reactions Phenylephrine Hydrochloride Injection 10 mg/mL 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.

5.7Peripheral and Visceral Ischemia IMMPHENTIV 100 mcg/mL and Phenylephrine Hydrochloride Injection 10 mg/mL can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.

5.8Renal Toxicity IMMPHENTIV 100 mcg/mL and Phenylephrine Hydrochloride Injection 10 mg/mL can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function.

🤒 Adverse Reactions 149 words ▾

6 ADVERSE REACTIONS The following adverse reactions associated with the use of phenylephrine hydrochloride were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Cardiac disorders : Bradycardia, AV block, ventricular extrasystoles, myocardial ischemia Gastrointestinal disorders : Nausea, vomiting General disorders and administrative site conditions : Chest pain, extravasation Immune system disorders : Sulfite sensitivity Nervous system disorders : Headache, nervousness, paresthesia, tremor Psychiatric disorders : Excitability Respiratory : Pulmonary edema, rales Skin and subcutaneous tissue disorders : Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation Vascular disorders : Hypertensive crisis Most common adverse reactions: nausea and vomiting, headache, nervousness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 117 words ▾

7 DRUG INTERACTIONS Agonistic effects with monoamine oxidase inhibitors (MAOI), β-adrenergic blocking agents, α-2 adrenergic agonists, steroids, tricyclic antidepressants, norepinephrine transport inhibitors, ergot alkaloids, centrally-acting sympatholytic agents and atropine sulfate ( 7.1 ) Antagonistic effects on and by α-adrenergic blocking agents ( 7.2 )

7.1Agonists The pressor effect of phenylephrine hydrochloride is increased in patients receiving: Monoamine oxidase inhibitors (MAOI), such as selegiline. β-adrenergic blockers α-2 adrenergic agonists, such as clonidine Steroids Tricyclic antidepressants Norepinephrine transport inhibitors, such as atomoxetine Ergot alkaloids, such as methylergonovine maleate Centrally-acting sympatholytic agents, such as guanfacine or reserpine Atropine sulfate

7.2Antagonists α-adrenergic blocking agents, including phenothiazines (e.g., chlorpromazine) and amiodarone block phenylephrine and are in turn blocked by phenylephrine.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary In animal reproductive and developmental studies, decreased fetal body weights were noted at 0.4 times the human daily dose (HDD) of 10 mg. No malformations were reported, however, an increased incidence of agenesis of the intermediate lobe of the lung, a visceral variation, was reported at levels as low as 0.08 times the HDD. The estimated background risk of major birth defects and miscarriage for the indicated population is 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 to 4% and 15 to 20%, respectively. Data Animal Data No malformations were noted when normotensive pregnant rats were treated with a single daily intravenous bolus dose of 50 mcg, 150 mcg, or 300/200 mcg/kg phenylephrine hydrochloride from Gestation Day 6 to 17 (high dose is 0.3/0.2 times the human daily dose (HDD) of 10 mg/day based on body surface area).

Evidence of maternal toxicity, including mortality, was noted at the highest tested dose of 300/200 mcg/kg. Decreased fetal body weights but no clear treatment-related malformations were reported when normotensive pregnant rabbits were treated with a single daily intravenous bolus dose of 40 mcg, 100 mcg and 200 mcg/kg (0.08, 0.2, and 0.4 times the HDD based on body surface area) phenylephrine hydrochloride from Gestation Day 7 to 19. Maternal toxicity, as manifested by decreased food consumption and body weight gain at all doses.

An increased incidence of agenesis of the intermediate lobe of the lung, a visceral variation, was noted in all treatment groups compared to controls. No adverse effects on the offspring were reported when pregnant rats were treated via a single daily intravenous bolus dose of up to 200 mcg/day phenylephrine hydrochloride (0.2 times the HDD based on body surface area) from Gestation Day 6 to Lactation Day 20. Pregnancy Category B Animal reproduction studies have not been conducted with phenylephrine.

It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine should be given to a pregnant woman only if clearly needed. However, the safety of its use for the management of hypotension associated with neuraxial anesthesia in cesarean deliveries is well established.

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

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.

8.6Hepatic Impairment In patients with liver cirrhosis [Child Pugh Class A (n=3), Class B (n=5) and Class C (n=1)], dose-response data indicate decreased responsiveness to phenylephrine. Consider using larger doses than usual in hepatic impaired subjects.

8.7Renal Impairment In patients with end stage renal disease (ESRD) undergoing hemodialysis, dose-response data indicates increased responsiveness to phenylephrine. Consider using lower doses of phenylephrine hydrochloride in ESRD patients.

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary In animal reproductive and developmental studies, decreased fetal body weights were noted at 0.4 times the human daily dose (HDD) of 10 mg. No malformations were reported, however, an increased incidence of agenesis of the intermediate lobe of the lung, a visceral variation, was reported at levels as low as 0.08 times the HDD. The estimated background risk of major birth defects and miscarriage for the indicated population is 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 to 4% and 15 to 20%, respectively. Data Animal Data No malformations were noted when normotensive pregnant rats were treated with a single daily intravenous bolus dose of 50 mcg, 150 mcg, or 300/200 mcg/kg phenylephrine hydrochloride from Gestation Day 6 to 17 (high dose is 0.3/0.2 times the human daily dose (HDD) of 10 mg/day based on body surface area).

Evidence of maternal toxicity, including mortality, was noted at the highest tested dose of 300/200 mcg/kg. Decreased fetal body weights but no clear treatment-related malformations were reported when normotensive pregnant rabbits were treated with a single daily intravenous bolus dose of 40 mcg, 100 mcg and 200 mcg/kg (0.08, 0.2, and 0.4 times the HDD based on body surface area) phenylephrine hydrochloride from Gestation Day 7 to 19. Maternal toxicity, as manifested by decreased food consumption and body weight gain at all doses.

An increased incidence of agenesis of the intermediate lobe of the lung, a visceral variation, was noted in all treatment groups compared to controls. No adverse effects on the offspring were reported when pregnant rats were treated via a single daily intravenous bolus dose of up to 200 mcg/day phenylephrine hydrochloride (0.2 times the HDD based on body surface area) from Gestation Day 6 to Lactation Day 20. Pregnancy Category B Animal reproduction studies have not been conducted with phenylephrine.

It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine should be given to a pregnant woman only if clearly needed. However, the safety of its use for the management of hypotension associated with neuraxial anesthesia in cesarean deliveries is well established.

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🧒 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 59 words ▾

10 OVERDOSAGE Overdose of IMMPHENTIV 100 mcg/mL and phenylephrine hydrochloride injection 10 mg/mL can cause a rapid rise in blood pressure. Symptoms of overdose include headache, vomiting, hypertension, reflex bradycardia, and cardiac arrhythmias including ventricular extrasystoles and ventricular tachycardia, and may cause a sensation of fullness in the head and tingling of the extremities. Consider using an α-adrenergic antagonist.

🧬 Clinical Pharmacology 215 words ▾

12 CLINICAL PHARMACOLOGY

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

12.2Pharmacodynamics Phenylephrine is the active moiety. Metabolites are inactive at both the α-1and α-2 adrenergic receptors. Following parenteral administration of phenylephrine hydrochloride, increases in systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, and total peripheral vascular resistance are observed.

The onset of blood pressure increase following an intravenous bolus phenylephrine hydrochloride administration is rapid and the effect may persist for up to 20 minutes. As mean arterial pressure increases following parenteral doses, vagal activity also increases, resulting in reflex bradycardia. Most vascular beds are constricted, including renal, splanchnic, and hepatic.

12.3Pharmacokinetics Following an intravenous infusion of phenylephrine hydrochloride, the effective half-life was approximately 5 minutes. The steady-state volume of distribution (340 L) exceeded the body volume by a factor of 5, suggesting a high distribution into certain organ compartments. The average total serum clearance (2095 mL/min) was close to one-third of the cardiac output.

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

🧬 Mechanism of Action 12 words ▾

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

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING IMMPHENTIV ® injection , USP, 100 mcg/mL Ready-to-Use vials is supplied as follows: NDC 0641-6245-10: 500 mcg in 5 mL (100 mcg/mL) single-dose vials packaged in cartons containing 10 vials per carton NDC 0641-6246-10: 1,000 mcg in 10 mL (100 mcg/mL) single-dose vials packaged in cartons containing 10 vials per carton Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Discard any unused portion.

Phenylephrine Hydrochloride injection , USP, 10 mg/mL, is supplied as follows: NDC 0641-6142-25: 10 mg in 1 mL fill (10 mg/mL) in 2 mL single-dose vials packaged in cartons containing 25 vials per carton NDC 0641-6188-10: 50 mg in 5 mL (10 mg/mL) Pharmacy Bulk Package vials packed in cartons containing 10 vials per carton NDC 0641-6189-10: 100 mg in 10 mL (10 mg/mL) Pharmacy Bulk Package vials packed in cartons containing 10 vials per carton Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Protect from light. Keep covered in carton until time of use. The 1 mL vials are for single-dose only.

Discard any unused portion. The 5 mL 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 (2°C – 8°C).

Discard any unused portion.

📋 Description ~1 min read ▾

11 DESCRIPTION Phenylephrine Hydrochloride Injection and IMMPHENTIV ® injection contain active pharmaceutical ingredient phenylephrine in the form of hydrochloride salt. Phenylephrine is a synthetic sympathomimetic agent in sterile form for parenteral injection. Phenylephrine hydrochloride chemical name is (-)- m -Hydroxy-α [(methylamino)methyl]benzyl alcohol hydrochloride and has the following structural formula: Phenylephrine hydrochloride is very soluble in water, freely soluble in ethanol, and insoluble in chloroform and ethyl ether.

Phenylephrine hydrochloride is sensitive to light. IMMPHENTIV ® Injection, 100 mcg/mL: IMMPHENTIV ® , USP, is a clear, colorless, aqueous solution that is essentially free of visible foreign matter, and Ready-To-Use formulation. Each mL contains: 100 mcg of Phenylephrine Hydrochloride USP (equivalent to 82 mcg of phenylephrine base), 7.5 mg of Sodium Chloride USP as tonicity agent; 4 mg of Sodium Citrate Dihydrate USP, and 1 mg of Citric Acid Monohydrate USP, as buffering agents, 0.2 mg of Edetate Disodium USP as chelating agent, and Sodium Hydroxide NF and Hydrochloric Acid NF as pH adjusters, in Water for Injection USP.

IMMPHENTIV ® injection pH range is 3.0 to 6.5. Phenylephrine Hydrochloride Injection, USP, 10 mg/mL : Phenylephrine Hydrochloride injection, USP is a clear, colorless, aqueous solution that is essentially free of visible foreign matter. It MUST BE DILUTED before administration as bolus intravenous infusion or continuous intravenous infusion.

Each mL contains: 10 mg of Phenylephrine Hydrochloride (equivalent to 8.2 mg of phenylephrine base); 3.5 mg of Sodium Chloride USP as tonicity agent; 1 mg of Citric Acid Monohydrate USP and 4 mg of Sodium Citrate Dihydrate USP, as buffering agents; 2 mg of Sodium Metabisulfite USP, as antioxidant, and Sodium Hydroxide NF and Hydrochloric Acid NF, as pH adjusters in Water for Injection. Phenylephrine Hydrochloride injection pH range is 3.0 to 6.5. Structural formula

💬 Information for Patients 116 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients, families, or caregivers that the primary side effect of phenylephrine is hypertension and, rarely, hypertensive crisis. Patients may experience bradycardia (slow heart rate), which in some cases may produce heart block or other cardiac arrhythmias, extra ventricular beats, myocardial ischemia in patients with underlying cardiac disease, and pulmonary edema (fluid in the lungs) or rales. Common, less serious symptoms include the following: chest pain skin or tissue damage if the drug leaks out of the venous catheter into the surrounding tissue headache, nervousness, tremor, numbness/tingling (paresthesias) in hands or feet nausea, vomiting excitability, dizziness, sweating, flushing Manufactured by: Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922 Revised: March 2023 462-664-05

🧬 Pharmacokinetics 107 words ▾

12.3Pharmacokinetics Following an intravenous infusion of phenylephrine hydrochloride, the effective half-life was approximately 5 minutes. The steady-state volume of distribution (340 L) exceeded the body volume by a factor of 5, suggesting a high distribution into certain organ compartments. The average total serum clearance (2095 mL/min) was close to one-third of the cardiac output.

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

🧬 Pharmacodynamics 93 words ▾

12.2Pharmacodynamics Phenylephrine is the active moiety. Metabolites are inactive at both the α-1and α-2 adrenergic receptors. Following parenteral administration of phenylephrine hydrochloride, increases in systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, and total peripheral vascular resistance are observed.

The onset of blood pressure increase following an intravenous bolus phenylephrine hydrochloride administration is rapid and the effect may persist for up to 20 minutes. As mean arterial pressure increases following parenteral doses, vagal activity also increases, resulting in reflex bradycardia. Most vascular beds are constricted, including renal, splanchnic, and hepatic.

🔬 Clinical Studies 81 words ▾

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

🧪 Nonclinical Toxicology 212 words ▾

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 B6C3F1 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/day based on body surface area) or rats administered approximately 50 mg/kg/day (48-times the 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: No adverse effects on fertility or early embryonic development were noted when phenylephrine hydrochloride was administered at doses of 50 mcg, 100 mcg, or 200 mcg/kg/day (up to 0.2 times HDD of 10 mg/60 kg/day based on body surface area) via single daily bolus injection for 28 days prior to mating to male rats or for 14 days prior to mating through Gestation Day 7 to female rats.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 209 words ▾

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 B6C3F1 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/day based on body surface area) or rats administered approximately 50 mg/kg/day (48-times the 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: No adverse effects on fertility or early embryonic development were noted when phenylephrine hydrochloride was administered at doses of 50 mcg, 100 mcg, or 200 mcg/kg/day (up to 0.2 times HDD of 10 mg/60 kg/day based on body surface area) via single daily bolus injection for 28 days prior to mating to male rats or for 14 days prior to mating through Gestation Day 7 to female rats.

📄 Recent Major Changes 19 words ▾

RECENT MAJOR CHANGES Indications and Usage ( 1 )............................................................ 03/2023 Dosage and Administration ( 2.1 , 2.2 )........................................... 03/2023

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL NDC 0641- 6142 -01 Phenylephrine HCl Injection, USP 10 mg/mL For Intravenous Use Dilute before use Protect from light 1 mL Single Dose Vial NDC 0641- 6142 -25 Rx only Phenylephrine HCl Injection, USP 10 mg/mL For Intravenous Use Dilute before use 25 x 1 mL Single Dose Vials Discard unused portion Phenylephrine HCI Injection, USP 1 mL SDV Container Label Phenylephrine HCI Injection, USP 1 mL SDV Carton Label

PRINCIPAL DISPLAY PANEL NDC 0641-6188-01 Rx only Phenylephrine HCl Injection, USP 50 mg/5 mL (10 mg/mL) Pharmacy Bulk Package Not for Direct Infusion For Intravenous Use Must Be Diluted Protect From Light 5 mL Vial NDC 0641-6188-10 Rx only Phenylephrine HCl Injection, USP 50 mg/5 mL (10 mg/mL) Pharmacy Bulk Package Not for Direct Infusion For Intravenous Use Must Be Diluted - Protect From Light Store in carton until time of use 10 x 5 mL Vials Vial Label Carton Label

PRINCIPAL DISPLAY PANEL NDC 0641-6189-01 Rx only Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package Not for Direct Infusion For Intravenous Use Must Be Diluted Protect From Light 10 mL Vial NDC 0641-6189-10 Rx only Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package Not for Direct Infusion For Intravenous Use Must Be Diluted - Protect From Light Store in carton until time of use 10 x 10 mL vials Vial Label Carton Label

PRINCIPAL DISPLAY PANEL NDC 0641-6245-01 Rx only IMMPHENTIV Phenylephrine HCl Injection, USP 500 mcg per 5 mL (100 mcg/mL) For Intravenous Use Ready to Use - Do NOT Dilute NDC 0641-6245-10 Rx only IMMPHENTIV Phenylephrine HCl Injection, USP 500 mcg per 5 mL (100 mcg/mL) For Intravenous Use Ready to Use - Do NOT Dilute 10 x 5 mL Single-Dose Vials Immphentiv RTU 5 mL Container Label 462-991-00 IMMPHENTIV 5 mL RTU Carton Label

PRINCIPAL DISPLAY PANEL NDC 0641-6246-01 Rx only IMMPHENTIV Phenylephrine HCl Injection, USP 1,000 mcg per 10 mL (100 mcg/mL) For Intravenous Use Ready to Use - Do NOT Dilute NDC 0641-6246-10 Rx only IMMPHENTIV Phenylephrine HCl Injection, USP 1,000 mcg per 10 mL (100 mcg/mL) For Intravenous Use Ready to Use - Do NOT Dilute 10 x 10 mL Single-Dose Vials Immphentiv RTU 10 mL Container Label 462-993-00 IMMPHENTIV 10 mL RTU Carton Label

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 ✓ Available
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 Hikma Pharmaceuticals USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hikma Pharmaceuticals USA Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 00641-6188-10 · Hikma 00641-6190-10 · Hikma →
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.