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Acetaminophen 10 mg/mL Injection — NDC 63323-434-00 (Billing 63323-0434-00)

by Fresenius Kabi USA, LLC · 20 BAG in 1 CASE / 100 mL in 1 BAG

This is a package of Acetaminophen 10 mg/mL Injection from Fresenius Kabi USA, LLC, marketed since Dec 2020 and currently FDA-listed. It is this product's only package size.

NDC 63323-0434-00
🏷️ FDA NDC (as labeled) 63323-434-00 billing pads the product 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 Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 63323-434-00 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63323 labeler · 434 product · 00 package
Package marketed since
Dec 6, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6332343400 7
Medicaid fills, this package
26,945 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Acetaminophen (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 21, 2025 — Defective Container (Kenvue Brands LLC) · FDA recall D-0121-2026
Class II · Aug 20, 2025 — Discoloration (Baxter Healthcare Corporation) · FDA recall D-0596-2025
Class II · May 22, 2025 — cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). (Aurobindo Pharma USA Inc) · FDA recall D-0471-2025
Class I · Jul 8, 2024 — Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) (Hikma Pharmaceuticals USA Inc.) · FDA recall D-0635-2024
Class II · May 20, 2024 — Discoloration: Brownish tablets (Contract Pharmacal Corporation) · FDA recall D-0566-2024
Class II · Nov 13, 2023 — Failed Impurities/Degradation Specifications (KINDER FARMS LLC) · FDA recall D-0143-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63323-434-00
Product NDC 63323-434
11-digit billing NDC 63323043400
NCPDP billing unit ML — per mL (volume)
RxCUI 483017
UNII 362O9ITL9D
Application # NDA204767
SPL Set ID a0cece43-256e-4adc-92f8-11a0f473bb83
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-12-06
Route INTRAVENOUS
Dosage form INJECTION
Substance ACETAMINOPHEN

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

GPI-14 64200010002070
GPI class Acetaminophen
GCN Seq No 073263
GCN 37643
HICL code 001866
Ingredient (HICL) Acetaminophen
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3E
Therapeutic class — specific (HIC3) Analgesic/Antipyretics,Non-Salicylate
AHFS code 28:08.16.00
AHFS class Non-Opioid Analgesics
FDB label name ACETAMINOPHEN 1000MG/100ML BAG
FDB brand name Acetaminophen
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 073263
  • GCN: 37643
  • GPI-14 (Medi-Span): 64200010002070
  • HICL (First Databank): 001866
  • AHFS class code: 28:08.16.00
  • RxCUI (RxNorm): 483017
Why two NDCs? The FDA registers this code as 63323-434-00 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63323-0434-00. 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 Anilides class.

Drug family (ATC) Anilides
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 ACETAMINOPHEN 1000MG/100ML BAG Ingredient Acetaminophen
📖 What it is MedlinePlus · NLM

Acetaminophen injection is used to relieve mild to moderate pain and to reduce fever. Acetaminophen injection is also used in combination with opioid (narcotic) medications to relieve moderate to severe pain. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves minor aches and pains, like headache, backache, toothache, muscle aches, cold aches, minor arthritis pain and menstrual cramps. It also reduces fever.
  • Follow your product label or prescriber exactly and never exceed the maximum daily amount. Remember that the limit counts every product with acetaminophen. Too much can seriously d...
  • Check the label first. Many combination products also contain acetaminophen, and you shouldn't use two together. If you aren't sure, ask me or your pharmacist.
  • Having 3 or more alcoholic drinks every day while using it raises the risk of liver damage. If you take warfarin, talk with your doctor or pharmacist first, since regular high dail...
📖 Read our full Acetaminophen guide →
1
Nutrient depletion considerations

Acetaminophen may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 $0.4983 $9.97 / 20 bags
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J0134 $0.050 / J0134 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)63323-434-00
11-digit billing NDC63323-0434-00
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ0134
DescriptorInjection, acetaminophen (fresenius kabi) not therapeutically equivalent to j0131, 10 mg
Billing units / pkg2,000 units
How the units are derivedThis package is 100; the HCPCS unit is 10 MG, so one package = 2000 billing units.
Medicare Part B spend (2026 (Q1))$35 · 12 claims · $2.88 per claim (all NDCs under J0134)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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
63323-0434-00 You're viewing this Main listing 20 BAG in 1 CASE / 100 mL in 1 BAG 2020-12-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acetaminophen 1000 mg/100mL 00143-9386-10 Hikma 100 ml — — FDA listed —
Acetaminophen 10 mg/mL 00264-4100-90 B. 100 ml — AP2 FDA listed —
Acetaminophen 10 mg/mL 00781-3156-95 Sandoz 10 vials — AP1 FDA listed —
Acetaminophen 10 mg/mL 00781-9274-95 Sandoz 10 vials — AP1 FDA listed —
Acetaminophen 10 mg/mL 24201-0100-24 Hikma 24 vials — AP1 FDA listed —
Acetaminophen 10 mg/mL 24201-0110-24 Hikma 24 vials — AP1 FDA listed —
Acetaminophen 10 mg/mL 25021-0705-82 Sagent 50 ml — AP2 FDA listed —
Acetaminophen 10 mg/mL 31722-0205-24 Camber 24 vials — AP1 FDA listed —
Acetaminophen 10 mg/mL 36000-0306-60 Baxter 100 ml — AP1 FDA listed —
Acetaminophen 10 mg/mL 44567-0340-10 WG 100 ml — AP1 FDA listed —
Acetaminophen 10 mg/mL 51662-1540-01 HF 100 ml — AP1 FDA listed —
Acetaminophen 10 mg/mL 55150-0307-24 Eugia 24 vials — AP1 FDA listed —
Acetaminophen 1000 mg/100mL 55579-0110-01 Solupharm 24 bottles — AP1 FDA listed —
Acetaminophen 10 mg/mL 55579-0405-24 Solupharm 24 vials — AP1 FDA listed —
Acetaminophen 10 mg/mLthis 63323-0434-00 Fresenius 100 ml — — FDA listed —
Acetaminophen 10 mg/mL 65145-0157-10 Caplin 10 pouches — AP1 FDA listed —
Acetaminophen 1000 mg/100mL 67457-0940-10 Mylan 100 ml — AP1 FDA listed —
Acetaminophen 10 mg/mL 68083-0648-01 Gland 100 ml — AP2 FDA listed —
Acetaminophen 10 mg/mL 70518-4184-02 REMEDYREPACK 25 vials — AP1 FDA listed —
Acetaminophen 10 mg/mL 72572-0050-10 Civica, 10 vials — AP1 FDA listed —
Acetaminophen 10 mg/mL 84549-0100-90 ProPharma 100 ml — AP2 FDA listed —
Acetaminophen 10 mg/mL 00264-4050-80 B. 50 ml — AP2 FDA listed —
Acetaminophen 10 mg/mL 36000-0372-40 Baxter 65 ml — AP1 FDA listed —
Acetaminophen 10 mg/mL 68083-0647-01 Gland 50 ml — AP2 FDA listed —
Acetaminophen 10 mg/mL 70069-0871-10 Somerset 10 pouches — 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

🏛️
2015
First FDA approval
Oct 2015
📍
2026
Currently FDA-listed
11 years listed
🛡️
2030
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 Apr 2030. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 28, 2015 RLD RS ⏳ ~3.5 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 8741959 — drug product
2015 2017 2019 2021 2023 2025 2027 2029
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 (1)
PatentTypeUse codeExpires
US 8741959 ↗ Drug product — Apr 19, 2030
Common questions
Is there a generic version of ACETAMINOPHEN 1000MG/100ML BAG?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for ACETAMINOPHEN 1000MG/100ML BAG. 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.

  • UNII ZT934N0X4W
    A naturally occurring amino acid salt used as a reducing agent and antioxidant in medications. It helps prevent ingredient breakdown and may improve product stability during storage.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • 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.

4 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

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationNDA204767 (NDA)
Labeler code63323
First marketedDec 2020
Product typeHuman Prescription Drug
Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 63323

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: Risk of Medication Errors and Hepatotoxicity Take care when prescribing, preparing, and administering Acetaminophen Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that: the dose in milligrams (mg) and milliliters (mL) is not confused; the dosing is based on weight for patients under 50 kg; infusion pumps are properly programmed; and the total daily dose of acetaminophen from all sources does not exceed maximum daily limits. Acetaminophen Injection contains acetaminophen.

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the maximum daily limits, and often involve more than one acetaminophen-containing product [see Warnings and Precautions ( 5.1 )]. WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY See full prescribing information for complete boxed warning Take care when prescribing, preparing, and administering Acetaminophen Injection to avoid dosing errors which could result in accidental overdose and death.

Acetaminophen Injection contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

( 5.1 )

🎯 Indications and Usage 119 words ▾

1 INDICATIONS AND USAGE Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older the reduction of fever in adult and pediatric patients 2 years and older. Acetaminophen Injection is indicated for the Management of mild to moderate pain in adult and pediatric patients 2 years and older ( 1 ) Management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older ( 1 ) Reduction of fever in adult and pediatric patients 2 years and older ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Acetaminophen Injection may be given as a single or repeated dose. ( 2.1 ) Acetaminophen Injection should be administered only as a 15-minute intravenous infusion. ( 2.4 ) Adults and Adolescents Weighing 50 kg and Over : 1,000 mg every 6 hours or 650 mg every 4 hours to a maximum of 4,000 mg per day.

Minimum dosing interval of 4 hours. ( 2.2 ) Adults and Adolescents Weighing Under 50 kg: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg per day. Minimum dosing interval of 4 hours.

( 2.2 ) Children: Children 2 to 12 years of age: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg per day. Minimum dosing interval of 4 hours. ( 2.3 )

2.1General Dosing Information Acetaminophen Injection, for intravenous use, may be given as a single or repeated dose for the treatment of acute pain or fever. No dose adjustment is required when converting between oral acetaminophen and acetaminophen injection dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of acetaminophen is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing acetaminophen.

Exceeding the maximum mg/kg daily dose of acetaminophen as described in Tables 1 and 2 may result in hepatic injury, including the risk of liver failure and death. To avoid the risk of overdose, ensure that the total amount of acetaminophen from all routes and from all sources does not exceed the maximum recommended dose.

2.2Recommended Dosage: Adults and Adolescents Adults and adolescents weighing 50 kg and over: the recommended dosage of acetaminophen injection is 1,000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of acetaminophen injection of 1,000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 4,000 mg per day (includes all routes of administration and all acetaminophen-containing products including combination products). Adults and adolescents weighing under 50 kg: the recommended dosage of acetaminophen injection is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of acetaminophen injection of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 75 mg/kg per day (includes all routes of administration and all acetaminophen-containing products including combination products).

Table 1. Dosing for Adults and Adolescents Age group Dose given every 4 hours Dose given every 6 hours Maximum single dose Maximum total daily dose of acetaminophen (by all routes) Adults and adolescents (13 years and older) weighing ≥ 50 kg 650 mg 1,000 mg 1,000 mg 4,000 mg in 24 hours Adults and adolescents (13 years and older) weighing < 50 kg 12.5 mg/kg 15 mg/kg 15 mg/kg (up to 750 mg) 75 mg/kg in 24 hours (up to 3,750 mg)

2.3Recommended Dosage: Children Children 2 to 12 years of age: the recommended dosage of acetaminophen injection is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of acetaminophen injection of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 75 mg/kg per day. Table 2. Dosing for Children Age group Dose given every 4 hours Dose given every 6 hours Maximum single dose Maximum total daily dose of acetaminophen (by all routes) Children 2 to 12 years of age 12.5 mg/kg 15 mg/kg 15 mg/kg (up to 750 mg) 75 mg/kg in 24 hours (up to 3,750 mg)

2.4Instructions for Intravenous Administration For adult and adolescent patients weighing ≥ 50 kg requiring 1,000 mg doses of acetaminophen injection, administer the dose by inserting an intravenous set through the administration spike port of the 100 mL bag. Acetaminophen Injection may be administered without further dilution. Examine the flexible bag contents before dose preparation or administering.

DO NOT USE if particulate matter or discoloration is observed. Administer the contents of the flexible b… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 54 words ▾

3 DOSAGE FORMS AND STRENGTHS Acetaminophen Injection is a sterile, clear, colorless, non-pyrogenic, preservative free, isotonic formulation of acetaminophen intended for intravenous infusion. Each 100 mL single-dose flexible bag contains 1,000 mg acetaminophen (10 mg/mL). Injection for intravenous infusion. Each 100 mL single-dose flexible bag contains 1,000 mg acetaminophen (10 mg/mL). ( 3 )

⛔ Contraindications 77 words ▾

4 CONTRAINDICATIONS Acetaminophen is contraindicated: in patients with known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation. in patients with severe hepatic impairment or severe active liver disease [see Warnings and Precautions ( 5.1 )]. Acetaminophen is contraindicated: In patients with known hypersensitivity to acetaminophen or to any of the excipients in the IV formulation. ( 4 ) In patients with severe hepatic impairment or severe active liver disease.

( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Administration of acetaminophen in doses higher than recommended (by all routes of administration and from all acetaminophen-containing products including combination products) may result in hepatic injury, including the risk of liver failure and death. ( 5.1 ) Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, in cases of alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment (creatinine clearance ≤ 30 mL/min).

( 5.1 ) Discontinue acetaminophen immediately at the first appearance of skin rash and if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy. ( 5.2 , 5.4 ) Take care when prescribing, preparing, and administering acetaminophen injection to avoid dosing errors which could result in accidental overdose and death.

( 5.3 )

5.1Hepatic Injury Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death [see Overdosage ( 10 )] . Do not exceed the maximum recommended daily dose of acetaminophen [see Dosage and Administration ( 2 )] . The maximum recommended daily dose of acetaminophen includes all routes of administration and all acetaminophen-containing products administered, including combination products.

Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance ≤ 30 mL/min) [see Use in Specific Populations ( 8.6 , 8.7 )] .

5.2Serious Skin Reactions Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

5.3Risk of Medication Errors Take care when prescribing, preparing, and administering acetaminophen injection in order to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that: the dose in milligrams (mg) and milliliters (mL) is not confused; the dosing is based on weight for patients under 50 kg; infusion pumps are properly programmed; and the total daily dose of acetaminophen from all sources does not exceed maximum daily limits [see Dosage and Administration ( 2 )] .

5.4Allergy and Hypersensitivity There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus. There were infrequent reports of life-threatening anaphylaxis requiring emergent medical attention.

Discontinue acetaminophen immediately if symptoms associated with allergy or hypersensitivity occur. Do not use acetaminophen in patients with acetaminophen allergy.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Hepatic Injury [see Warnings and Precautions ( 5.1 )] Serious Skin Reactions [see Warnings and Precautions ( 5.2 )] Allergy and Hypersensitivity [see Warnings and Precautions ( 5.4 )] The most common adverse reactions in patients treated with acetaminophen were nausea, vomiting, headache, and insomnia in adult patients; nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551- 7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice. Adult Population A total of 1,020 adult patients have received acetaminophen in clinical trials, including 37.3% (n=380) who received 5 or more doses, and 17% (n=173) who received more than 10 doses. Most patients were treated with acetaminophen 1,000 mg every 6 hours.

A total of 13.1% (n=134) received acetaminophen 650 mg every 4 hours. All adverse reactions that occurred in adult patients treated with either acetaminophen or placebo in repeated dose, placebo-controlled clinical trials at an incidence ≥ 3% and at a greater frequency than placebo are listed in Table 3 . The most common adverse events in adult patients treated with acetaminophen (incidence ≥ 5% and greater than placebo) were nausea, vomiting, headache, and insomnia.

Table 3. Treatment-Emergent Adverse Reactions Occurring in ≥ 3% of Acetaminophen- treated Adult Patients and at a Greater Frequency than Placebo in Placebo-Controlled, Repeated Dose Studies * Pyrexia adverse reaction frequency data is included in order to alert healthcare practitioners that the antipyretic effects of acetaminophen may mask fever. System Organ Class - Preferred Term Acetaminophen (N=402) n (%) Placebo (N=379) n (%) Gastrointestinal Disorders Nausea Vomiting 138 (34) 62 (15) 119 (31) 42 (11) General Disorders and Administration Site Conditions Pyrexia* 22 (5) 52 (14) Nervous System Disorders Headache 39 (10) 33 (9) Psychiatric Disorders Insomnia 30 (7) 21 (5) Other Adverse Reactions Observed During Clinical Studies of Acetaminophen in Adults The following additional treatment-emergent adverse reactions were reported by adult subjects treated with acetaminophen in all clinical trials (n=1,020) that occurred with an incidence of at least 1% and at a frequency greater than placebo (n=525).

Blood and lymphatic system disorders : anemia General disorders and administration site conditions : fatigue, infusion site pain, edema peripheral Investigations : aspartate aminotransferase increased, breath sounds abnormal Metabolism and nutrition disorders : hypokalemia Musculoskeletal and connective tissue disorders : muscle spasms, trismus Psychiatric disorders : anxiety Respiratory, thoracic and mediastinal disorders : dyspnea Vascular disorders : hypertension, hypotension Pediatric Population A total of 355 pediatric patients (47 neonates, 64 infants, 171 children, and 73 adolescents) have received acetaminophen in active-controlled (n=250) and open-label clinical trials (n=225), including 59.7% (n=212) who received 5 or more doses and 43.1% (n=153) who received more than 10 doses.

Pediatric patients received acetaminophen doses up to 15 mg/kg on an every 4 hours, every 6 hours, or every 8 hours schedule. The maximum exposure was 7.7, 6.4, 6.8, and 7.1 days in neonates, infants, children, and adolescents, respectively. The most common adverse events (incidence ≥ 5%) in pediatric patients treated with acetaminophen were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.

Other Adverse Reactions Observed During Clinical Studies of Acetaminophen in Pediatrics The following additional trea… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 192 words ▾

7 DRUG INTERACTIONS Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 may alter the metabolism of acetaminophen and increase its hepatotoxic potential. ( 7.1 ) Chronic oral acetaminophen use at a dose of 4,000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant. ( 7.2 )

7.1Effects of Other Substances on Acetaminophen Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 may alter the metabolism of acetaminophen and increase its hepatotoxic potential. The clinical consequences of these effects have not been established. Effects of ethanol are complex, because excessive alcohol usage can induce hepatic cytochromes, but ethanol also acts as a competitive inhibitor of the metabolism of acetaminophen.

7.2Anticoagulants Chronic oral acetaminophen use at a dose of 4,000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant. As no studies have been performed evaluating the short-term use of acetaminophen in patients on oral anticoagulants, more frequent assessment of INR may be appropriate in such circumstances.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatric Use: The effectiveness of acetaminophen for the treatment of acute pain in pediatric patients younger than 2 years of age has not been established. The safety and effectiveness of acetaminophen in pediatric patients older than 2 years of age is supported by evidence from adequate and well-controlled studies in adults with additional safety and pharmacokinetic data for this age group. ( 8.4 ) Geriatric Use: No overall differences in safety or effectiveness were observed between geriatric and younger subjects.

( 8.5 ) Hepatic Impairment: Acetaminophen is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease. ( 4 , 5.1 , 8.6 ) Renal Impairment: In cases of severe renal impairment, longer dosing intervals and a reduced total daily dose of acetaminophen may be warranted. ( 5.1 , 8.7 )

8.1Pregnancy Risk Summary Prolonged experience with acetaminophen in pregnant women over several decades, based on published observational epidemiological studies and case reports, did not identify a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . Animal reproduction studies have not been conducted with IV acetaminophen. Reproductive and developmental studies in rats and mice from the published literature identified adverse events at clinically relevant doses with acetaminophen.

Treatment of pregnant rats with doses of acetaminophen approximately equal to the maximum human daily dose (MHDD) showed evidence of fetotoxicity and increases in bone variations in the fetuses. In another study, necrosis was observed in the liver and kidney of both pregnant rats and fetuses at doses approximately equal to the MHDD. In mice and rats treated with acetaminophen at doses within the clinical dosing range, cumulative adverse effects on reproductive capacity were reported.

In mice, a reduction in number of litters of the parental mating pair was observed as well as retarded growth, abnormal sperm in their offspring and reduced birth weight in the next generation. In rats, female fertility was decreased following in utero exposure to acetaminophen (see Data ) . The estimated background risk of major birth defects and miscarriages 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 2-4% and 15-20%, respectively. Data Human Data The results from a large population-based prospective cohort, including data from 26,424 women with live born singletons who were exposed to oral acetaminophen during the first trimester, indicate no increased risk for congenital malformations, compared to a control group of unexposed children.

The rate of congenital malformations (4.3%) was similar to the rate in the general population. A population-based, case-control study from the National Birth Defects Prevention Study showed that 11,610 children with prenatal exposure to acetaminophen during the first trimester had no increased risk of major birth defects compared to 4,500 children in the control group. Other epidemiological data showed similar results.

However, these studies cannot definitively establish the absence of any risk because of methodological limitations, including recall bias. Animal Data Studies in pregnant rats that received oral acetaminophen during organogenesis at doses up to 0.85 times the maximum human daily dose (MHDD = 4 grams/day, based on a body surface area comparison) showed evidence of fetotoxicity (reduced fetal weight and length) and a dose-related increase in bone variations (reduced ossification and rudimentary rib changes). Offspring had no evidence of external, visceral, or skeletal malformations.

When pregnant rat… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Prolonged experience with acetaminophen in pregnant women over several decades, based on published observational epidemiological studies and case reports, did not identify a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . Animal reproduction studies have not been conducted with IV acetaminophen. Reproductive and developmental studies in rats and mice from the published literature identified adverse events at clinically relevant doses with acetaminophen.

Treatment of pregnant rats with doses of acetaminophen approximately equal to the maximum human daily dose (MHDD) showed evidence of fetotoxicity and increases in bone variations in the fetuses. In another study, necrosis was observed in the liver and kidney of both pregnant rats and fetuses at doses approximately equal to the MHDD. In mice and rats treated with acetaminophen at doses within the clinical dosing range, cumulative adverse effects on reproductive capacity were reported.

In mice, a reduction in number of litters of the parental mating pair was observed as well as retarded growth, abnormal sperm in their offspring and reduced birth weight in the next generation. In rats, female fertility was decreased following in utero exposure to acetaminophen (see Data ) . The estimated background risk of major birth defects and miscarriages 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 2-4% and 15-20%, respectively. Data Human Data The results from a large population-based prospective cohort, including data from 26,424 women with live born singletons who were exposed to oral acetaminophen during the first trimester, indicate no increased risk for congenital malformations, compared to a control group of unexposed children.

The rate of congenital malformations (4.3%) was similar to the rate in the general population. A population-based, case-control study from the National Birth Defects Prevention Study showed that 11,610 children with prenatal exposure to acetaminophen during the first trimester had no increased risk of major birth defects compared to 4,500 children in the control group. Other epidemiological data showed similar results.

However, these studies cannot definitively establish the absence of any risk because of methodological limitations, including recall bias. Animal Data Studies in pregnant rats that received oral acetaminophen during organogenesis at doses up to 0.85 times the maximum human daily dose (MHDD = 4 grams/day, based on a body surface area comparison) showed evidence of fetotoxicity (reduced fetal weight and length) and a dose-related increase in bone variations (reduced ossification and rudimentary rib changes). Offspring had no evidence of external, visceral, or skeletal malformations.

When pregnant rats received oral acetaminophen throughout gestation at doses of 1.2 times the MHDD (based on a body surface area comparison), areas of necrosis occurred in both the liver and kidney of pregnant rats and fetuses. These effects did not occur in animals that received oral acetaminophen at doses 0.3 times the MHDD, based on a body surface area comparison. In a continuous breeding study, pregnant mice received 0.25, 0.5, or 1% acetaminophen via the diet (357, 715, or 1,430 mg/kg/day).

These doses are approximately 0.43, 0.87, and 1.7 times the MHDD, respectively, based on a body surface area comparison. A dose related reduction in body weights of fourth and fifth litter offspring of the treated mating pair occurred during lactation and post-weaning at all doses. Animals in the high dose group had a reduced number of litters per mating pair, male offspring with an increased percentage of abnormal sperm, and reduced birth weights in the next generation… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 133 words ▾

8.4Pediatric Use Treatment of Acute Pain The safety and effectiveness of acetaminophen for the treatment of acute pain in pediatric patients ages 2 years and older is supported by evidence from adequate and well- controlled studies of acetaminophen in adults and safety and pharmacokinetic data from adult and 355 pediatric patients across all age groups [see Dosage and Administration ( 2.3 ) and Pharmacokinetics ( 12.3 )] . The effectiveness of acetaminophen for the treatment of acute pain in pediatric patients younger than 2 years of age has not been established.

Treatment of Fever The safety and effectiveness of acetaminophen injection for the treatment of fever in pediatric patients is supported by adequate and well-controlled studies of acetaminophen injection in adults and clinical studies in 244 pediatric patients 2 years and older.

🧓 Geriatric Use 70 words ▾

8.5Geriatric Use Of the total number of subjects in clinical studies of acetaminophen, 15% were age 65 and over, while 5% were age 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE Signs and Symptoms In acute acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may also occur. Plasma acetaminophen levels > 300 mcg/mL at 4 hours after oral ingestion were associated with hepatic damage in 90% of patients; minimal hepatic damage is anticipated if plasma levels at 4 hours are < 150 mcg/mL or < 37.5 mcg/mL at 12 hours after ingestion.

Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Treatment If an acetaminophen overdose is suspected, obtain a serum acetaminophen assay as soon as possible, but no sooner than 4 hours following oral ingestion.

Obtain liver function studies initially and repeat at 24-hour intervals. Administer the antidote N-acetylcysteine (NAC) as early as possible. As a guide to treatment of acute ingestion, the acetaminophen level can be plotted against time since oral ingestion on a nomogram (Rumack-Matthew).

The lower toxic line on the nomogram is equivalent to 150 mcg/mL at 4 hours and 37.5 mcg/mL at 12 hours. If serum level is above the lower line, administer the entire course of NAC treatment. Withhold NAC therapy if the acetaminophen level is below the lower line.

For additional information, call a poison control center at 1-800-222-1222.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanism of the analgesic and antipyretic properties of acetaminophen is not established but is thought to primarily involve central actions.

12.2Pharmacodynamics Acetaminophen has been shown to have analgesic and antipyretic activities in animal and human studies. Single doses of acetaminophen up to 3,000 mg and repeated doses of 1,000 mg every 6 hours for 48 hours have not been shown to cause a significant effect on platelet aggregation. Acetaminophen does not have any immediate or delayed effects on small-vessel hemostasis.

Clinical studies of both healthy subjects and patients with hemophilia showed no significant changes in bleeding time after receiving multiple doses of oral acetaminophen.

12.3Pharmacokinetics Distribution The pharmacokinetics of acetaminophen have been studied in patients and healthy subjects up to 60 years old. The pharmacokinetic profile of acetaminophen has been demonstrated to be dose proportional in adults following administration of single doses of 500, 650, and 1,000 mg. The maximum concentration (Cmax) occurs at the end of the 15-minute intravenous infusion of acetaminophen.

Compared to the same dose of oral acetaminophen, the Cmax following administration of acetaminophen is up to 70% higher, while overall exposure (area under the concentration time curve [AUC]) is very similar. Pharmacokinetic parameters of acetaminophen (AUC, C max , terminal elimination half-life [T 1/2 ], systemic clearance [CL], and volume of distribution at steady state [Vss]) following administration of a single intravenous dose of 15 mg/kg in children and adolescents and 1,000 mg in adults are summarized in Table 4 .

Table 4. Acetaminophen Pharmacokinetic Parameters Subpopulations Mean (SD) AUC 0-6h (μg x h/mL) C max (μg/mL) T 1/2 (h) CL (L/h/kg) Vss (L/kg) Neonates 62 (11) 25 (4) 7 (2.7) 0.12 (0.04) 1.1 (0.2) Infants 57 (54) 29 (24) 4.2 (2.9) 0.29 (0.15) 1.1 (0.3) Children 38 (8) 29 (7) 3 (1.5) 0.34 (0.10) 1.2 (0.3) Adolescents 41 (7) 31 (9) 2.9 (0.7) 0.29 (0.08) 1.1 (0.3) Adults 43 (11) 28 (21) 2.4 (0.6) 0.27 (0.08) 0.8 (0.2) The pharmacokinetic exposure of acetaminophen observed in children and adolescents is similar to adults, but higher in neonates and infants.

Dosing simulations from pharmacokinetic data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a pharmacokinetic exposure similar to that observed in children age 2 years and older. At therapeutic levels, binding of acetaminophen to plasma proteins is low (ranging from 10% to 25%). Acetaminophen appears to be widely distributed throughout most body tissues except fat.

Metabolism and Excretion Acetaminophen is primarily metabolized in the liver by first-order kinetics and involves three principal separate pathways: Conjugation with glucuronide, conjugation with sulfate, and oxidation via the cytochrome P450 enzyme pathway, primarily CYP2E1, to form a reactive intermediate metabolite (N-acetyl-p-benzoquinone imine or NAPQI). With therapeutic doses, NAPQI undergoes rapid conjugation with glutathione and is then further metabolized to form cysteine and mercapturic acid conjugates. Acetaminophen metabolites are mainly excreted in the urine.

Less than 5% is excreted in the urine as unconjugated (free) acetaminophen and more than 90% of the administered dose is excreted within 24 hours.

🧬 Mechanism of Action 26 words ▾

12.1Mechanism of Action The precise mechanism of the analgesic and antipyretic properties of acetaminophen is not established but is thought to primarily involve central actions.

📦 How Supplied / Storage and Handling 180 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Acetaminophen Injection is supplied as follows: Product Code Unit of Sale Strength Unit of Use 434100 NDC 63323-434-00 Package of 20 Single-dose flexible bags 1,000 mg per 100 mL (10 mg per mL) NDC 63323-434-41 100 mL Single-dose flexible bag Do not remove unit from overwrap until ready for use. To open, tear outer wrap at the notch and remove solution bag. After removing the outer wrap, check the container for minute leaks by squeezing the solution bag firmly.

If leaks are found, discard the solution because the sterility may be impaired. A small amount of moisture may be present inside the outer wrap. Acetaminophen Injection should be stored at 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

For single use only. The product should be used within 24 hours after opening. Do not refrigerate or freeze.

The container is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Manufactured for: Lake Zurich, IL 60047 Made in Norway www.fresenius-kabi.com/us 451659D Fresenius Kabi Logo

📋 Description 89 words ▾

11 DESCRIPTION Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Its structural formula is: M.W.

151.16 Acetaminophen Injection, for intravenous use, is a sterile, clear, colorless, non-pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. Each 100 mL contains 1,000 mg of Acetaminophen, USP; 3,670 mg of mannitol, 10 mg of cysteine, and hydrochloric acid and sodium hydroxide as pH adjusters, in water for injection. Acetaminophen Injection has a pH between 5.0 and 6.3, and an osmolality of approximately 290 mOsm/kg.

Structural Formula

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Distribution The pharmacokinetics of acetaminophen have been studied in patients and healthy subjects up to 60 years old. The pharmacokinetic profile of acetaminophen has been demonstrated to be dose proportional in adults following administration of single doses of 500, 650, and 1,000 mg. The maximum concentration (Cmax) occurs at the end of the 15-minute intravenous infusion of acetaminophen.

Compared to the same dose of oral acetaminophen, the Cmax following administration of acetaminophen is up to 70% higher, while overall exposure (area under the concentration time curve [AUC]) is very similar. Pharmacokinetic parameters of acetaminophen (AUC, C max , terminal elimination half-life [T 1/2 ], systemic clearance [CL], and volume of distribution at steady state [Vss]) following administration of a single intravenous dose of 15 mg/kg in children and adolescents and 1,000 mg in adults are summarized in Table 4 .

Table 4. Acetaminophen Pharmacokinetic Parameters Subpopulations Mean (SD) AUC 0-6h (μg x h/mL) C max (μg/mL) T 1/2 (h) CL (L/h/kg) Vss (L/kg) Neonates 62 (11) 25 (4) 7 (2.7) 0.12 (0.04) 1.1 (0.2) Infants 57 (54) 29 (24) 4.2 (2.9) 0.29 (0.15) 1.1 (0.3) Children 38 (8) 29 (7) 3 (1.5) 0.34 (0.10) 1.2 (0.3) Adolescents 41 (7) 31 (9) 2.9 (0.7) 0.29 (0.08) 1.1 (0.3) Adults 43 (11) 28 (21) 2.4 (0.6) 0.27 (0.08) 0.8 (0.2) The pharmacokinetic exposure of acetaminophen observed in children and adolescents is similar to adults, but higher in neonates and infants.

Dosing simulations from pharmacokinetic data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a pharmacokinetic exposure similar to that observed in children age 2 years and older. At therapeutic levels, binding of acetaminophen to plasma proteins is low (ranging from 10% to 25%). Acetaminophen appears to be widely distributed throughout most body tissues except fat.

Metabolism and Excretion Acetaminophen is primarily metabolized in the liver by first-order kinetics and involves three principal separate pathways: Conjugation with glucuronide, conjugation with sulfate, and oxidation via the cytochrome P450 enzyme pathway, primarily CYP2E1, to form a reactive intermediate metabolite (N-acetyl-p-benzoquinone imine or NAPQI). With therapeutic doses, NAPQI undergoes rapid conjugation with glutathione and is then further metabolized to form cysteine and mercapturic acid conjugates. Acetaminophen metabolites are mainly excreted in the urine.

Less than 5% is excreted in the urine as unconjugated (free) acetaminophen and more than 90% of the administered dose is excreted within 24 hours.

🧬 Pharmacodynamics 85 words ▾

12.2Pharmacodynamics Acetaminophen has been shown to have analgesic and antipyretic activities in animal and human studies. Single doses of acetaminophen up to 3,000 mg and repeated doses of 1,000 mg every 6 hours for 48 hours have not been shown to cause a significant effect on platelet aggregation. Acetaminophen does not have any immediate or delayed effects on small-vessel hemostasis.

Clinical studies of both healthy subjects and patients with hemophilia showed no significant changes in bleeding time after receiving multiple doses of oral acetaminophen.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES

14.1Adult Acute Pain The efficacy of acetaminophen in the treatment of acute pain in adults was evaluated in two randomized, double-blind, placebo-controlled clinical trials in patients with postoperative pain. Pain Study 1 evaluated the analgesic efficacy of repeated doses of acetaminophen 1,000 mg vs. placebo every 6 hours for 24 hours in 101 patients with moderate to severe pain following total hip or knee replacement. Acetaminophen was statistically superior to placebo for reduction in pain intensity over 24 hours.

There was an attendant decrease in opioid consumption, the clinical benefit of which was not demonstrated. Pain Study 2 evaluated the analgesic efficacy of repeated doses of acetaminophen 1,000 mg every 6 hours or 650 mg every 4 hours for 24 hours versus placebo in the treatment of 244 patients with moderate to severe postoperative pain after abdominal laparoscopic surgery. Patients receiving acetaminophen experienced a statistically significant greater reduction in pain intensity over 24 hours compared to placebo.

14.2Adult Fever The efficacy of acetaminophen 1,000 mg in the treatment of adult fever was evaluated in one randomized, double-blind, placebo-controlled clinical trial. The study was a 6-hour, single-dose, endotoxin-induced fever study in 60 healthy adult males. A statistically significant antipyretic effect of acetaminophen was demonstrated through 6 hours in comparison to placebo.

The mean temperature over time is shown in Figure 1 . Figure 1: Mean Temperature (ºC) Over Time Figure 1

14.3Pediatric Acute Pain and Fever Acetaminophen was studied in 355 pediatric patients in two active-controlled trials and three open-label safety and pharmacokinetic trials [see Use in Specific Populations ( 8.4 )] .

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in mice and rats have been completed by the National Toxicology Program to evaluate the carcinogenic potential of acetaminophen. In 2-year feeding studies, F344/N rats and B6C3F1 mice were fed a diet containing acetaminophen up to 6,000 ppm. Female rats demonstrated equivocal evidence of carcinogenic activity based on increased incidences of mononuclear cell leukemia at 0.8 times the maximum human daily dose (MHDD) of 4 grams/day, based on a body surface area comparison.

In contrast, there was no evidence of carcinogenic activity in male rats (0.7 times) or mice (1.2-1.4 times the MHDD, based on a body surface area comparison). Mutagenesis Acetaminophen was not mutagenic in the bacterial reverse mutation assay (Ames test). In contrast, acetaminophen tested positive in the in vitro mouse lymphoma assay and the in vitro chromosomal aberration assay using human lymphocytes.

In the published literature, acetaminophen has been reported to be clastogenic when administered a dose of 1,500 mg/kg/day to the rat model (3.6 times the MHDD, based on a body surface area comparison). In contrast, no clastogenicity was noted at a dose of 750 mg/kg/day (1.8 times the MHDD, based on a body surface area comparison), suggesting a threshold effect. Impairment of Fertility In studies conducted by the National Toxicology Program, fertility assessments have been completed in Swiss mice via a continuous breeding study.

There were no effects on fertility parameters in mice consuming up to 1.7 times the MHDD of acetaminophen, based on a body surface area comparison. Although there was no effect on sperm motility or sperm density in the epididymis, there was a significant increase in the percentage of abnormal sperm in mice consuming 1.7 times the MHDD (based on a body surface area comparison) and there was a reduction in the number of mating pairs producing a fifth litter at this dose, suggesting the potential for cumulative toxicity with chronic administration of acetaminophen near the upper limit of daily dosing.

Published studies in rodents report that oral acetaminophen treatment of male animals at doses that are 1.2 times the MHDD and greater (based on a body surface area comparison) result in decreased testicular weights, reduced spermatogenesis, reduced fertility, and reduced implantation sites in females given the same doses. These effects appear to increase with the duration of treatment. In a published mouse study, oral administration of 50 mg/kg acetaminophen to pregnant mice from Gestation Day 7 to delivery (0.06 times the MHDD, based on a body surface area comparison) reduced the number of primordial follicles in female offspring and reduced the percentage of full term pregnancies and number of pups born to these females exposed to acetaminophen in utero.

In a published study, oral administration of 350 mg/kg acetaminophen to pregnant rats (0.85 times the MHDD, based on a body surface area comparison) from Gestation Day 13 to 21 (dams) reduced the number of germ cells in the fetal ovary, decreased ovary weight, and reduced the number of pups per litter in F 1 females as well as reduced ovary weights in F 2 females.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in mice and rats have been completed by the National Toxicology Program to evaluate the carcinogenic potential of acetaminophen. In 2-year feeding studies, F344/N rats and B6C3F1 mice were fed a diet containing acetaminophen up to 6,000 ppm. Female rats demonstrated equivocal evidence of carcinogenic activity based on increased incidences of mononuclear cell leukemia at 0.8 times the maximum human daily dose (MHDD) of 4 grams/day, based on a body surface area comparison.

In contrast, there was no evidence of carcinogenic activity in male rats (0.7 times) or mice (1.2-1.4 times the MHDD, based on a body surface area comparison). Mutagenesis Acetaminophen was not mutagenic in the bacterial reverse mutation assay (Ames test). In contrast, acetaminophen tested positive in the in vitro mouse lymphoma assay and the in vitro chromosomal aberration assay using human lymphocytes.

In the published literature, acetaminophen has been reported to be clastogenic when administered a dose of 1,500 mg/kg/day to the rat model (3.6 times the MHDD, based on a body surface area comparison). In contrast, no clastogenicity was noted at a dose of 750 mg/kg/day (1.8 times the MHDD, based on a body surface area comparison), suggesting a threshold effect. Impairment of Fertility In studies conducted by the National Toxicology Program, fertility assessments have been completed in Swiss mice via a continuous breeding study.

There were no effects on fertility parameters in mice consuming up to 1.7 times the MHDD of acetaminophen, based on a body surface area comparison. Although there was no effect on sperm motility or sperm density in the epididymis, there was a significant increase in the percentage of abnormal sperm in mice consuming 1.7 times the MHDD (based on a body surface area comparison) and there was a reduction in the number of mating pairs producing a fifth litter at this dose, suggesting the potential for cumulative toxicity with chronic administration of acetaminophen near the upper limit of daily dosing.

Published studies in rodents report that oral acetaminophen treatment of male animals at doses that are 1.2 times the MHDD and greater (based on a body surface area comparison) result in decreased testicular weights, reduced spermatogenesis, reduced fertility, and reduced implantation sites in females given the same doses. These effects appear to increase with the duration of treatment. In a published mouse study, oral administration of 50 mg/kg acetaminophen to pregnant mice from Gestation Day 7 to delivery (0.06 times the MHDD, based on a body surface area comparison) reduced the number of primordial follicles in female offspring and reduced the percentage of full term pregnancies and number of pups born to these females exposed to acetaminophen in utero.

In a published study, oral administration of 350 mg/kg acetaminophen to pregnant rats (0.85 times the MHDD, based on a body surface area comparison) from Gestation Day 13 to 21 (dams) reduced the number of germ cells in the fetal ovary, decreased ovary weight, and reduced the number of pups per litter in F 1 females as well as reduced ovary weights in F 2 females.

📄 Package Label / Principal Display Panel 143 words ▾

PACKAGE LABEL - PRINCIPAL DISPLAY – Acetaminophen 100 mL Bag Label Acetaminophen NDC 63323-434-41 Injection 434100 1,000 mg per 100 mL (10 mg per mL ) For Intravenous Infusion Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – Acetaminophen 100 mL Bag Label

PACKAGE LABEL - PRINCIPAL DISPLAY - Acetaminophen 100 mL Foil Overwrap To Open Overwrap - Tear at Notch Acetaminophen NDC 63323-434-41 Injection 434100 1,000 mg per 100 mL (10 mg per mL ) For Intravenous Infusion Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY - Acetaminophen 100 mL Foil Overwrap PACKAGE LABEL - PRINCIPAL DISPLAY - Acetaminophen 100 mL Foil Overwrap

PACKAGE LABEL - PRINCIPAL DISPLAY - Acetaminophen 100 mL Case Label NDC 63323-434-00 434100 Acetaminophen Injection 1,000 mg per 100 mL (10 mg per mL ) 100 mL x 20 PACKAGE LABEL - PRINCIPAL DISPLAY - Acetaminophen 100 mL Case Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
26.9K
Units reimbursed last 4 qtrs
2.6M
Gross reimbursed last 4 qtrs
$1.29M
Avg / prescription
$47.74
Avg / unit
$0.4983
Latest quarter Q1 2026
5.2KRx
Fee-for-service vs managed care ⓘ
18% FFS 82% MCO
Fee-for-service · 4,750 Rx Managed care · 22,195 Rx
State Medicaid map
Alaska: no data reported AK Maine: 805 units · 57.7 per 100k residents ME Washington: 46,030 units · 589 per 100k residents WA Idaho: 28,858 units · 1,469 per 100k residents ID Montana: 34,277 units · 3,028 per 100k residents MT North Dakota: 1,100 units · 140 per 100k residents ND Minnesota: 10,421 units · 182 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 161,083 units · 823 per 100k residents NY Vermont: 29,381 units · 4,541 per 100k residents VT New Hampshire: 23,601 units · 1,683 per 100k residents NH Oregon: 40,126 units · 948 per 100k residents OR Nevada: 56,600 units · 1,772 per 100k residents NV Wyoming: no data reported WY South Dakota: 6,301 units · 686 per 100k residents SD Iowa: 100,767 units · 3,142 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 125,796 units · 1,067 per 100k residents OH Pennsylvania: 218,756 units · 1,688 per 100k residents PA New Jersey: 529,329 units · 5,698 per 100k residents NJ Massachusetts: 146,051 units · 2,086 per 100k residents MA California: 376,872 units · 967 per 100k residents CA Utah: 2,131 units · 62.4 per 100k residents UT Colorado: no data reported CO Nebraska: 8,700 units · 440 per 100k residents NE Missouri: 46,300 units · 747 per 100k residents MO Kentucky: 60,438 units · 1,335 per 100k residents KY West Virginia: no data reported WV Virginia: 9,176 units · 105 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: 3,400 units · 311 per 100k residents RI Arizona: no data reported AZ New Mexico: 22,507 units · 1,065 per 100k residents NM Kansas: 900 units · 30.6 per 100k residents KS Arkansas: no data reported AR Tennessee: 75,946 units · 1,066 per 100k residents TN North Carolina: 14,882 units · 137 per 100k residents NC South Carolina: no data reported SC Delaware: 53,100 units · 5,150 per 100k residents DE Oklahoma: 32,959 units · 813 per 100k residents OK Louisiana: 73,805 units · 1,614 per 100k residents LA Mississippi: 34,992 units · 1,190 per 100k residents MS Alabama: no data reported AL Georgia: 16,574 units · 150 per 100k residents GA D.C.: 7,100 units · 1,046 per 100k residents DC Hawaii: no data reported HI Texas: 53,912 units · 177 per 100k residents TX Florida: 128,514 units · 568 per 100k residents FL
Units reimbursed · per 100k residents
30.65,698
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Jersey 5,698 /100k
2 Delaware 5,150 /100k
3 Vermont 4,541 /100k
4 Iowa 3,142 /100k
5 Montana 3,028 /100k
6 Massachusetts 2,086 /100k
7 Nevada 1,772 /100k
8 Pennsylvania 1,688 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Acetaminophen — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Acetaminophen. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$34K
Claims incl. refills
277
Beneficiaries
145
Spend / beneficiary
$234.25
Spend / claim
$122.62
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The 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 Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC 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 J0134 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.
← 63323-0426-05 · Fresenius 63323-0450-50 · Fresenius →
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.