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Acetaminophen 1000 mg/100mL Injection — NDC 55579-0110-01 package photo
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Acetaminophen 1000 mg/100mL Injection — NDC 55579-110-01 (Billing 55579-0110-01)

by Solupharm Pharmazeutische Erzeugnisse GmbH · 24 BOTTLE in 1 BOTTLE / 100 mL in 1 BOTTLE

This is a package of Acetaminophen 1000 mg/100mL Injection from Solupharm Pharmazeutische Erzeugnisse GmbH, marketed since Dec 2020 and currently FDA-listed. It is this product's only package size.

NDC 55579-0110-01
🏷️ FDA NDC (as labeled) 55579-110-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
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) 55579-110-01
Product NDC 55579-110
11-digit billing NDC 55579011001
RxCUI 483017
UNII 362O9ITL9D
Application # ANDA202605
SPL Set ID adeebc6c-c82f-40dc-b813-1b02244984ce
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-12-07
Route INTRAVENOUS
Dosage form INJECTION
Substance ACETAMINOPHEN
TE code (Orange Book) AP1 · RLD · RS
Quick answers
  • RxCUI (RxNorm): 483017
Why two NDCs? The FDA registers this code as 55579-110-01 — 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 → 55579-0110-01. 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

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

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
55579-0110-01 You're viewing this Main listing 24 BOTTLE in 1 BOTTLE / 100 mL in 1 BOTTLE 2023-03-01 — 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/100mLthis 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/mL 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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2020
On the market since
Dec 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

Inactive Ingredients / Excipients

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

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

  • UNII 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 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 94255I6E2T
    Sodium phosphate dibasic dihydrate is a salt that helps control the acidity level of a medicine. It acts as a buffer and pH regulator to keep the medication stable and effective.

3 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

LabelerSolupharm Pharmazeutische Erzeugnisse GmbH
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA202605 (ANDA)
Labeler code55579
First marketedDec 2020
Product typeHuman Prescription Drug
Portfolio10 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 114 words ▾

ACETAMINOPHEN injection for intravenous use 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 (1) 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.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • ACETAMINOPHEN injection for intravenous use may be given as a single or repeated dose. (2.1) • ACETAMINOPHEN injection for intravenous use should be administered only as a 15-minute intravenous infusion. (2.4) Adults and Adolescents Weighing 50 kg and Over: • 1000 mg every 6 hours or 650 mg every 4 hours to a maximum of 4000 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) Neonates and Infants: • Neonates including premature neonates born at ≥ 32 weeks gestational age to 28 days chronological age, 12.5 mg/kg every 6 hours to a maximum of 50 mg/kg per day.

Minimum dosing interval of 6 hours. (2.4) • Infants (29 days to 2 years of age): 15 mg/kg every 6 hours to a maximum of 60 mg/kg per day. Minimum dosing interval of 6 hours.

(2.4) (2)

2.1General Dosing Information Acetaminophen injection 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 1-3 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 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of acetaminophen injection of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 4000 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 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 1000 mg 1000 mg 4000 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 3750 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 3750 mg)

2.4Recommended Dosage For Treatment of Fever in Neonates and Infants Neonates, including premature neonates born at 32 weeks g… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 55 words ▾

3 DOSAGE FORMS AND STRENGTHS Acetaminophen injection is a sterile, clear, colorless to slightly yellowish, non-pyrogenic, preservative free, isotonic formulation of acetaminophen intended for intravenous infusion. Each 100 mL glass vial contains 1000 mg acetaminophen (10 mg/mL). • Injection for intravenous infusion. • Each 100 mL glass vial contains 1000 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 IV formulation. (4) • In patients with severe hepatic impairment or severe active liver disease. (4) 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)].

⚠️ 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 injection for intravenous use 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 for intravenous use 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 acetaminophen 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 injection immediately if symptoms associated with allergy or hypersensitivity occur. Do not use acetaminophen injection in patients with acetaminophen allergy.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS ACETAMINOPHEN injection for intravenous use 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 (1) (1) The most common adverse reactions in patients treated with ACETAMINOPHEN injection for intravenous use were nausea, vomiting, headache, and insomnia in adult patients; nausea, vomiting, constipation, and pruritus in pediatric patients.

(6.1) (6) To report SUSPECTED ADVERSE REACTIONS, contact Hikma at us.hikma@ primevigilance.com or call 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. (6)

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 1020 adult patients have received acetaminophen injection in clinical trials, including 37.3% (n=380) who received 5 or more doses, and 17.0% (n=173) who received more than 10 doses. Most patients were treated with acetaminophen injection 1000 mg every 6 hours.

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

Table 4. Treatment-Emergent Adverse Reactions Occurring in 3% of Acetaminophen Injection-treated Adult Patients and at a Greater Frequency than Placebo in Placebo-Controlled, Repeated Dose Studies System Organ Class – Preferred Term Acetaminophen Injection (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) * Pyrexia adverse reaction frequency data is included in order to alert healthcare practitioners that the antipyretic effects of Acetaminophen Injection may mask fever.

Other Adverse Reactions Observed During Clinical Studies of Acetaminophen Injection in Adults The following additional treatment-emergent adverse reactions were reported by adult subjects treated with acetaminophen injection in all clinical trials (n=1020) 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 I nvestigations: 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 483 pediatric patients (72 neonates, 167 infants, 171 children, and 73 adolescents) have received acetaminophen injection in active-controlled (n=250) and open-label clinical trials (n=225), including 43.9% (n=212) who received 5 or more doses and 31.2% (n=153) who received more than 10 doses.

Pediatric patients received acetaminophen injection 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 tr… [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 4000 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)

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 4000 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 injection in patients on oral anticoagulants, more frequent assessment of INR may be appropriate in such circumstances.

👥 Use in Specific Populations ~3 min read ▾

USE IN SPECIFIC POPULATIONS • Pediatric Use: The effectiveness of ACETAMINOPHEN injection for intravenous use 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 injection for intravenous use in pediatric patients 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 injection for intravenous use 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) Revised: 05/2022 (8) Revised: 2/2023

8.1Pregnancy Risk Summary Published epidemiological studies with oral acetaminophen use during pregnancy have not reported a clear association with acetaminophen use and 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 definitely 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 skeleta… [Excerpted — this section continues on DailyMed.]

🧬 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 injection up to 3000 mg and repeated doses of 1000 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 injection have been studied in patients and healthy subjects up to 60 years old. The pharmacokinetic profile of acetaminophen injection has been demonstrated to be dose proportional in adults following administration of single doses of 500, 650, and 1000 mg. The maximum concentration (Cmax) occurs at the end of the 15-minute intravenous infusion of acetaminophen injection.

Compared to the same dose of oral acetaminophen, the Cmax following administration of acetaminophen injection is up to 70% higher, while overall exposure (area under the concentration time curve [AUC]) is very similar. Pharmacokinetic parameters of acetaminophen injection (AUC, Cmax, terminal elimination half-life [T½], 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 1000 mg in adults are summarized in Table 5.

Table 5. Acetaminophen Injection Pharmacokinetic Parameters Subpopulations AUC0-6h (μg × h/ mL) Cmax (μg/mL) T½ (h) CL (L/h/kg) Vss (L/kg) Children 38 (8) 29 (7) 3.0 (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 concentrations of acetaminophen injection observed in neonates greater than 32 weeks gestational age at birth treated with 12.5 mg/kg dose are similar to infants, children and adolescents treated with a 15 mg/kg dose, and similar to adults treated with a 1000 mg dose.

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.

📦 How Supplied / Storage and Handling 83 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Acetaminophen injection is supplied in a 100 mL glass vial containing 1000 mg acetaminophen (10 mg/mL) in cartons of 24 vials. NDC 24201-110-24 Acetaminophen injection should be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. For single-dose only.

The product should be used within 6 hours after opening. Do not refrigerate or freeze. Manufactured for: Hikma Berkeley Heights, NJ 07922 Made in Germany Novaplus is a registered trademark of Vizient, Inc.

Revised: 05/2022

📋 Description 98 words ▾

11 DESCRIPTION Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16.

Its structural formula is: Acetaminophen injection is a sterile, clear, colorless to slightly yellowish, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 5.5 and an osmolality of approximately 290 mOsm/kg. Each 100 mL contains 1000 mg acetaminophen, USP, 3850 mg D-mannitol, USP, 25 mg cysteine hydrochloride, monohydrate, USP, and 13 mg disodium phosphate dihydrate, USP. pH may have been adjusted with hydrochloric acid and/or sodium hydroxide.

Structure

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES

14.1Adult Acute Pain The efficacy of acetaminophen injection 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 injection 1000 mg vs. placebo every 6 hours for 24 hours in 101 patients with moderate to severe pain following total hip or knee replacement. Acetaminophen injection 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 injection 1000 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 injection experienced a statistically significant greater reduction in pain intensity over 24 hours compared to placebo.

14.2Adult Fever The efficacy of acetaminophen injection 1000 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 injection was demonstrated through 6 hours in comparison to placebo.

The mean temperature over time is shown in Figure 1. Figure 1: Mean Temperature (°C) Over Time Structure2

14.3Pediatric Acute Pain and Fever Acetaminophen injection was studied in pediatric patients in three 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 6000 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 1500 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 F1 females as well as reduced ovary weights in F2 females.

📄 Recent Major Changes 10 words ▾

Dosage and Administration (2.5) 11/2016 Dosage and Administration (2.4) 01/2017

📄 Package Label / Principal Display Panel 4 words ▾

Package Labeling: Label 2

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

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

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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.
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Solupharm Pharmazeutische Erzeugnisse GmbH 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.
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← 55570-0540-10 · Jost 55579-0306-05 · Solupharm →
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