FDA-filed SPL labeling · retrieved through openFDA

Propofol

Propofol is an intravenous anesthetic and sedation drug used to induce and maintain general anesthesia, provide monitored sedation during procedures, and keep critically ill adults sedated on a breathing machine in the ICU.

Brand names DiprivanPropovanPropovenPropofol Injectable EmulsionPropofol Lipuro
Drug class ⓘ General Anesthetic
Rx Forms 2 Route Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 18 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveApr 18, 2024
Clinical labels in scope ⓘ18
AvailabilityRx
Earliest approval/marketing year ⓘ1989
FDA-listed product records ⓘ109
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 17, 2026
⭐ Propofol at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Propofol is a powerful, fast-acting intravenous anesthetic used in operating rooms and ICUs — it is never taken at home and is always administered and closely monitored by trained medical professionals. It works quickly but can significantly lower blood pressure and suppress breathing, so careful dosing and continuous monitoring are essential. Knowing your allergy history, especially to eggs or soy, and telling your care team about all medications you take are the most important steps you can do before receiving it.
How we write & review this content — our editorial policy →

📖 Propofol: Patient Information Guide

A plain-language walkthrough of Propofol — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Propofol is an intravenous anesthetic and sedation drug supported across several products and formulations. Here is the full set of approved uses:

  • Induction (starting) of general anesthesia in patients 3 years of age and older — supported by Propofol Injectable Emulsion, Diprivan, and propofol injection
  • Maintenance (keeping) of general anesthesia in patients 2 months of age and older — supported by Propofol Injectable Emulsion, Diprivan, and propofol injection
  • Initiation and maintenance of monitored anesthesia care (MAC) sedation — a lighter, controlled sedation during procedures — in adults only
  • Sedation in adults receiving regional anesthesia (numbing a specific body area)
  • Continuous ICU sedation for intubated, mechanically ventilated adults — supported by Diprivan and Propofol Injectable Emulsion
  • Diprivan is not recommended for use during obstetrical procedures including cesarean deliveries, or in nursing mothers
  • MAC sedation and ICU sedation in children (pediatric patients) are not approved indications for any of these products
  • Propofol injection is not recommended for anesthesia induction under 3 years of age or anesthesia maintenance under 2 months of age
⚙️How it works▾

Propofol is believed to work by enhancing the activity of GABA (gamma-aminobutyric acid), the brain's primary inhibitory (calming) chemical messenger. It does this by binding to GABA-A receptors — specialized proteins on nerve cells — causing them to stay open longer and slow down brain activity. This produces rapid sedation or full unconsciousness, typically within about 40 seconds of an IV injection. When the infusion is stopped, the drug redistributes from the brain into body tissues and is then broken down by the liver and cleared through the kidneys, allowing patients to wake up relatively quickly.

💊How it's taken▾

Propofol is given exclusively by intravenous injection or continuous IV infusion in a clinical setting — it is never taken by mouth. For anesthesia, it is given at the start of a procedure to put the patient to sleep and then continued as a drip to keep them asleep throughout surgery. For ICU sedation, it is delivered as a continuous, carefully adjusted infusion. The rate is constantly titrated (fine-tuned) based on the patient's clinical response and level of sedation — no fixed schedule applies. Older adults and patients in poorer health typically require lower rates of administration.

  • Always given and adjusted by trained medical professionals
  • Continuous vital sign monitoring is required throughout administration
  • Dose adjustments should be made slowly (allowing 3–5 minutes) to assess the effect before changing the rate
🤒Side effects — in detail▾

Like all anesthetics, propofol can cause a range of side effects, most of which are managed by the medical team during administration:

  • Low blood pressure (hypotension) — very common, occurring in about 26% of adults during anesthesia
  • Slow heart rate (bradycardia) and reduced heart output
  • Brief pauses in breathing (apnea) — frequent after induction in both adults and children
  • Burning, stinging, or pain at the IV injection site — affects about 18% of adults
  • Involuntary muscle movements during or after sedation
  • Skin rash or itching
  • Elevated blood fat (triglyceride) levels, especially with prolonged infusions
  • Nausea, dizziness, or headache during recovery

More serious reactions — including severe allergic reactions (anaphylaxis), dangerously slow or stopped heartbeat, seizures during recovery, and the rare but potentially fatal Propofol Infusion Syndrome — require immediate medical attention and discontinuation of the drug.

⚠️Warnings & precautions▾
  • Cardiorespiratory depression: Propofol can cause dangerous drops in blood pressure, stopped breathing, and airway obstruction — especially with rapid injection or in elderly and debilitated patients. Full resuscitation equipment must be immediately available.
  • Propofol Infusion Syndrome: A rare but potentially fatal condition associated with high-dose or prolonged ICU infusions, characterized by severe metabolic acidosis, high potassium, muscle breakdown (rhabdomyolysis), liver enlargement, kidney failure, and heart failure. Risk factors include serious brain injury, sepsis, and high-dose, prolonged infusions over 48 hours.
  • Microbial contamination risk: Propofol supports microbial growth. Vials are for single-patient, single-use only. Failure to use strict sterile technique has caused life-threatening infections, including transmission of hepatitis B, hepatitis C, and HIV.
  • Pediatric neurotoxicity: Animal studies show that anesthetic drugs affecting GABA and NMDA receptors can damage the developing brain when used for more than 3 hours, particularly in children under approximately 3 years of age. The clinical significance in humans is not fully established, but timing of elective procedures should be carefully considered.
  • Cardiac risk in children: Serious slowing of the heart (bradycardia, asystole, and cardiac arrest) has been reported in pediatric patients, particularly when fentanyl is given at the same time.
  • Benzyl alcohol risk in infants: Propofol Injectable Emulsion contains benzyl alcohol, which can cause a life-threatening "gasping syndrome" in premature neonates and infants. Total benzyl alcohol exposure from all medications must be considered.
🔀What it interacts with▾

Propofol interacts with several drug classes that affect the brain, heart, and breathing — your care team will manage these carefully:

  • Opioids (morphine, fentanyl, meperidine): Deepen sedation and further lower blood pressure and cardiac output; fentanyl given with propofol in children can cause serious bradycardia
  • Benzodiazepines and other sedatives (e.g., lorazepam, barbiturates): Add to CNS depression; may allow a lower propofol dose to be used
  • Valproate (a seizure drug): Raises propofol blood levels — the propofol dose must be reduced and the patient monitored closely for excess sedation or cardiovascular depression
  • Inhaled anesthetic agents (isoflurane, sevoflurane, desflurane, enflurane, halothane): Increase both the anesthetic effect and cardiovascular depression when combined with propofol
  • Nitrous oxide: Can be combined with propofol for surgical anesthesia and reduces the amount of propofol needed
  • Neuromuscular blocking agents (succinylcholine, nondepolarizing relaxants): Propofol does not significantly change their onset or duration, but the combination warrants careful monitoring of vagal tone and heart rate

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Allergy to eggs, soy, or propofol itself: Propofol is contraindicated — do not receive it if you have a history of anaphylaxis (severe allergic reaction) to eggs, egg products, soybeans, or soy products
  • High blood triglycerides, pancreatitis, or lipid metabolism disorders: Use with caution; propofol is formulated in a fat (lipid) emulsion and can raise blood fat levels further
  • Epilepsy (seizure disorder): There is a risk of seizures during recovery from propofol anesthesia
  • Increased pressure in the brain (intracranial hypertension): Requires very careful, slow dosing to prevent dangerous blood pressure drops that reduce blood flow to the brain
  • Pregnancy: Propofol crosses the placenta and can cause temporary sedation and low muscle tone in the newborn; Diprivan is specifically not recommended for obstetric use or cesarean deliveries
  • Breastfeeding: Propofol passes into breast milk; discuss timing of breastfeeding after receiving propofol with your care team
  • Children under 3 years: Not approved for anesthesia induction below age 3; not approved for ICU or MAC sedation in any pediatric patients
  • Older adults and debilitated patients: More sensitive to blood pressure and breathing effects; require lower doses and slower infusion rates, with continuous monitoring
  • Liver or kidney disease: The pharmacokinetics of propofol do not appear to be significantly different in patients with chronic liver cirrhosis or chronic kidney impairment, but acute liver or kidney failure has not been fully studied
🚑If you take too much▾

Too much propofol is likely to cause severe depression of breathing and heart function. If overdose occurs, propofol must be stopped immediately. Breathing support with oxygen and artificial ventilation is the first response. If blood pressure and heart function drop, treatment may include repositioning the patient with legs elevated, giving IV fluids, and administering medications to support blood pressure and heart rate.

📡Pharmacodynamics — effects in the body▾

Propofol's effects on the body depend closely on the concentration of drug in the blood — higher concentrations, especially from rapid or large bolus doses, are more likely to cause dangerous drops in blood pressure and breathing suppression. During anesthesia induction, blood pressure can fall by more than 30%. Propofol also lowers pressure inside the eye (intraocular pressure) and, when combined with low carbon dioxide levels (hypocarbia), reduces blood flow to the brain and lowers pressure inside the skull — effects that are clinically useful in certain neurosurgical settings. It does not significantly trigger the release of histamine and has not been shown to cause malignant hyperthermia (a dangerous reaction to some anesthetics involving extreme muscle activity and high body temperature).

🔬Pharmacokinetics — how your body processes it▾

After an IV injection, propofol reaches the brain within about 40 seconds and induces anesthesia rapidly. It is then quickly redistributed from the brain into other body tissues, which is why it wears off fast after short use. The drug is primarily broken down (metabolized) in the liver into inactive byproducts that are cleared through the kidneys. With prolonged infusions — such as 10 days of ICU sedation — propofol accumulates in fat and muscle tissue, slowing recovery when the infusion is stopped. Older adults develop higher peak blood levels for the same dose compared to younger adults, which explains why they need lower doses. Children aged 3–12 years process propofol similarly to adults.

📦How to store it▾

Store between 4° to 25°C (40° to 77°F). Do not freeze.

📄 Written from Propofol’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Propofol — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is propofol used for? Why am I getting it? ▾
Propofol is a fast-acting anesthetic and sedation drug given through an IV. Most commonly, you'd receive it to put you to sleep and keep you comfortable during surgery, or to keep you calm and sedated if you're on a breathing machine in the ICU. It works very quickly — usually within about 40 seconds — and wears off relatively fast when it's stopped, which is one reason it's widely used in surgical and critical care settings.
Will I feel anything when it's given? Will I remember anything? ▾
Most people don't feel much more than a brief burning or stinging sensation in the vein where it's injected — that's one of the more common things patients notice. Within seconds you'll feel very drowsy and then unconscious. You generally won't remember anything that happens while you're under propofol, which is entirely expected and the whole point of an anesthetic.
What side effects should I know about after receiving propofol? ▾
The most common effects — like a drop in blood pressure, slowed heart rate, or a brief pause in breathing right after injection — happen while you're being monitored and are managed by your care team in real time. After you wake up, you might notice some itching, a skin rash, dizziness, or nausea. Serious reactions like a severe allergic response are rare but possible, so you'll be watched closely the entire time.
I'm allergic to eggs. Can I still receive propofol? ▾
This is really important to tell your care team before any procedure. Propofol is formulated in a lipid (fat) emulsion that contains egg and soy components, and it is contraindicated — meaning it should not be used — if you have a history of a severe allergic reaction (anaphylaxis) to eggs, egg products, soybeans, or soy products. Your anesthesiologist needs to know about this allergy so they can plan a safe alternative.
Is propofol safe if I'm pregnant or breastfeeding? ▾
Propofol does cross the placenta, meaning it can reach your baby during delivery, and there are reports of temporary sedation and low muscle tone in newborns after exposure. Diprivan specifically is not recommended for use during obstetric procedures, including cesarean sections. If you're breastfeeding, propofol does appear in breast milk; talk to your care team about the best timing for resuming breastfeeding after you've received it.
Are there medications I take at home that could interact with propofol? ▾
Yes — several common medications can interact with propofol. If you take valproate (a seizure or mood medication), it can raise propofol levels in your blood, increasing the depth of sedation and strain on your heart and breathing. Other sedatives, opioid pain medications, and sleep aids can all add to propofol's sedative and blood-pressure-lowering effects. Make sure your anesthesia team has a complete and current list of everything you take, including supplements, before your procedure.
Is Propofol available over the counter? ▾
Propofol is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Propofol first available? ▾
Propofol has been available in the United States since at least 1989, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Propofol? ▾
Propofol is supplied by 34 manufacturers listed in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Hospira, Inc., NorthStar Rx LLC.

💬 Answers drafted from Propofol’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

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💊 How Propofol comes

Propofol is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Into a vein
Brands Diprivan Propofol Injectable Emulsion Propofol Lipuro
How this form is used
What it may be used for
  • Propofol Injectable Emulsion and Diprivan are used to induce (start) general anesthesia in patients 3 years of age and older
  • Propofol Injectable Emulsion and Diprivan are used to maintain general anesthesia in patients 2 months of age and older
  • Diprivan is used for monitored anesthesia care (MAC) sedation and sedation combined with regional anesthesia in adults
  • Diprivan and Propofol Injectable Emulsion are used for continuous ICU sedation in intubated, mechanically ventilated adult patients
Important instructions
  • Propofol Injectable Emulsion and Diprivan are given only as an intravenous infusion or injection by trained medical professionals — never self-administered
  • Propofol Injectable Emulsion vials must be shaken well before use, used for a single patient only, and any unused portion discarded within 12 hours of opening
  • Diprivan and Propofol Injectable Emulsion doses are adjusted continuously based on the patient's clinical response; vital signs are monitored throughout
  • Propofol Injectable Emulsion must be prepared under strict sterile technique immediately before use, with the vial rubber stopper disinfected prior to access
Available strengths 1 strength
10 mg/mL
97 FDA-listed product records ⓘ

Oral solution

By mouth
Available strengths 2 strengths
1 kg/kg 2 kg/2 kg
7 FDA-listed product records ⓘ

📊 Propofol across the U.S. market

How Propofol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2
Dose forms ⓘ
34
Manufacturers
5
Brand names
109
FDA-listed product records ⓘ
1989
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Fresenius Kabi USA, LLC14%
Hospira, Inc.10%
NorthStar Rx LLC8%
Pfizer Laboratories Div Pfizer Inc8%
Civica, Inc8%
Dr. Reddy's Laboratories, Inc.6%
Other makers46%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Propofol is used

A general measure of how commonly Propofol is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Propofol is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

520,319
Medicaid prescriptions filled (Q1–Q4 2025)
$55.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Propofol prescribed? Of the 1,596 medications we measure, Propofol ranks #258 by Medicaid prescriptions — more than 84% of them.

Where Propofol ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #258 of 1,596
#253 Chlorthalidone 561,590 Rx #254 Bisacodyl 542,387 Rx #255 Metronidazole Vaginal 541,965 Rx #256 Methotrexate 533,549 Rx #257 Labetalol 525,457 Rx #258 Propofol 520,319 Rx #259 Pioglitazone 511,848 Rx #260 Dextromethorphan / Gua... 511,044 Rx #261 Clobazam 496,684 Rx #262 Prednisolone Ophthalmi... 496,500 Rx #263 Mometasone Topical 494,371 Rx

Utilization by Propofol product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 20 mL / 10 mg/mL injection is the most-dispensed Propofol product — about 76% of these Medicaid prescriptions.

20 ML propofol 10 MG/ML Injection Most dispensed

393,137 Medicaid prescriptions (Q1–Q4 2025) 76% of Propofol prescriptions shown $38.7M gross reimbursement (before rebates) ≈ $99 per prescription (gross)

Summed across the 18 of 41 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1808224

100 ML propofol 10 MG/ML Injection

63,532 Medicaid prescriptions (Q1–Q4 2025) 12% of Propofol prescriptions shown $8.3M gross reimbursement (before rebates) ≈ $131 per prescription (gross)

Summed across the 12 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1808217

50 ML propofol 10 MG/ML Injection

56,907 Medicaid prescriptions (Q1–Q4 2025) 11% of Propofol prescriptions shown $7.2M gross reimbursement (before rebates) ≈ $127 per prescription (gross)

Summed across the 13 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1808222

10 ML propofol 10 MG/ML Injection

6,313 Medicaid prescriptions (Q1–Q4 2025) 1% of Propofol prescriptions shown $853,597 gross reimbursement (before rebates) ≈ $135 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1808234

Other Propofol products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

430 Medicaid prescriptions (Q1–Q4 2025) <1% of Propofol prescriptions shown $14,475 gross reimbursement (before rebates) ≈ $34 per prescription (gross)

Summed across the 1 of 23 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Propofol, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 46 of 134 listed Propofol NDCs with Medicaid activity.

🔍 Compare Propofol products

A representative set of FDA-listed product records for Propofol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 109 of 109 products — FDA National Drug Code Directory. See every product, package size and price: browse all 109 Propofol NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Propofol RxCUI 8782 2 dose forms · 7 strengths
  1. Dose form (SCDF) Injectable Suspension RxCUI 377483 In current FDA listings
    Clinical drug / strength (SCD) lipid emulsion 10 MG/ML RxCUI 2561291 10 MG/ML RxCUI 312674

Look up RxCUI 8782 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Diprivan Propovan Propoven Propofol Injectable Emulsion Propofol Lipuro

🏭 Manufacturers & labelers

Fresenius Kabi USA, LLC 15 Hospira, Inc. 11 NorthStar Rx LLC 9 Pfizer Laboratories Div Pfizer Inc 9 Civica, Inc 9 Dr. Reddy's Laboratories, Inc. 6 HF Acquisition Co LLC, DBA HealthFirst 6 Hikma Pharmaceuticals USA Inc. 6 Civica, Inc. 3 Meitheal Pharmaceuticals Inc. 3 Sagent Pharmaceuticals 3 Amneal Pharmaceuticals Private Limited 3 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 3 Remedyrepack Inc. 2 SI Group, Inc. 2 Porton Pharma Solutions Ltd 1 Harman Finochem Limited 1 Professional Compounding Centers of America 1 Professional Compounding Centers of America dba PCCA 1 Neuland Laboratories Limited 1 La Mesta Chimie Fine Sas 1 Henry Schein, Inc. 1 A-S Medication Solutions 1 Genixus 1

…and 10 more on the FDA NDC directory.

RxNorm drug class

Propofol belongs to the General Anesthetic class.

Pharmacologic class General Anesthetic
Drug family (ATC) Other general anesthetics

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 18, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Propofol.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Propofol after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
18
NDC products indexed
109
Distinct labelers/manufacturers represented
34
Linked representative label ⓘ
Fresenius Kabi USA, LLC
Linked label effective
Apr 18, 2024
Composite sections available
24
Linked SPL Set ID
5cec3b97-5183-4a9d-accd-21e76c99d3dd
Linked SPL Document ID
8d8838c0-3c0c-4732-ade1-12f76001c50b
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 18 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Fresenius Kabi USA, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.