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Ceftaroline Fosamil 600 mg/20mL Injection, Powder, Lyophilized, For Solution — NDC 60505-6125-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ceftaroline Fosamil 600 mg/20mL Injection, Powder, Lyophilized, For Solution — NDC 60505-6125-1 (Billing 60505-6125-01)

by Apotex Corp. · 10 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE

This is a package of Ceftaroline Fosamil 600 mg/20mL Injection, Powder, Lyophilized, For Solution from Apotex Corp., marketed since Feb 2026 and currently FDA-listed. It is this product's only package size.

NDC 60505-6125-01
🏷️ FDA NDC (as labeled) 60505-6125-1 billing pads the package 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 →

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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 60505-6125-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
60505 labeler · 6125 product · 1 package
Package marketed since
Feb 12, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6050561251 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 60505-6125-1
Product NDC 60505-6125
11-digit billing NDC 60505612501
NCPDP billing unit EA — each (per item)
RxCUI 1040008, 1040014
UNII 7P6FQA5D21
Application # ANDA208075
SPL Set ID 3cee3c08-ed60-06c5-ac49-103b7ad2ef5f
Established class (EPC) Cephalosporin Antibacterial
Chemical class Cephalosporins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-12
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance CEFTAROLINE FOSAMIL
TE code (Orange Book) AP · RLD · RS

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

GPI-14 02500030102130
GCN Seq No 066811
GCN 29214
HICL code 037243
Ingredient (HICL) Ceftaroline Fosamil Acetate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W9
Therapeutic class — intermediate (HIC2) Antibiotics (Continued 1)
HIC3 code W9G
Therapeutic class — specific (HIC3) Cephalosporin Antibiotics - 5Th Generation
AHFS code 08:12.06.20
AHFS class 5Th Generation Cephalosporin Antibiotics
FDB label name CEFTAROLINE FOSAMIL 600 MG VL
FDB brand name Ceftaroline Fosamil
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066811
  • GCN: 29214
  • GPI-14 (Medi-Span): 02500030102130
  • HICL (First Databank): 037243
  • AHFS class code: 08:12.06.20
  • RxCUI (RxNorm): 1040008
Why two NDCs? The FDA registers this code as 60505-6125-1 — a 5-4-1 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 package segment → 60505-6125-01. 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 Other cephalosporins and penems class.

Drug family (ATC) Other cephalosporins and penems
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 CEFTAROLINE FOSAMIL 600 MG VL Ingredient Ceftaroline Fosamil Acetate

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 mLPer 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 · Q2 2026 $232.54 $46,508.96 / 200 ml
Medicare Part B allowsASP · J0712 $4.390 / J0712 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)60505-6125-1
11-digit billing NDC60505-6125-01
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ0712
DescriptorInjection, ceftaroline fosamil, 10 mg
Billing units / pkg600 units
How the units are derivedThis package is 1; the HCPCS unit is 10 MG, so one package = 600 billing units.
Medicare Part B spend (2026 (Q1))$80,030 · 122 claims · $655.99 per claim (all NDCs under J0712)
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
60505-6125-01 You're viewing this Main listing 10 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE 2026-02-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Teflaro 600 mg/20mL 00456-0600-10 Allergan, 10 vials — AP FDA listed —
Ceftaroline Fosamil 600 mg/20mLthis 60505-6125-01 Apotex 10 vials — AP FDA listed —
Ceftaroline Fosamil 600 mg/20mL 60505-4947-01 Apotex 10 vials — AP 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

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.

1 inactive ingredient 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

LabelerApotex Corp.
Application holderAPOTEX INC
FDA applicationANDA208075 (ANDA)
Labeler code60505
First marketedFeb 2026
Product typeHuman Prescription Drug
Portfolio306 products on file

More NDCs from Apotex Corp. labeler code 60505

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 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

1. INDICATIONS AND USAGE Ceftaroline fosamil for injection is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) ( 1.1 ) Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftaroline fosamil for injection and other antibacterial drugs, ceftaroline fosamil for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

( 1.3 )

1.1Acute Bacterial Skin and Skin Structure Infections Ceftaroline fosamil for injection is indicated in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes , Streptococcus agalactiae , Escherichia coli , Klebsiella pneumoniae, and Klebsiella oxytoca [see Dosage and Administration (2.2) and Use in Specific Populations ( 8.4 )].

1.2Community-Acquired Bacterial Pneumonia Ceftaroline fosamil for injection is indicated in adult and pediatric patients 2 months of age and older for the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

1.3Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftaroline fosamil for injection and other antibacterial drugs, ceftaroline fosamil for injection should be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to ceftaroline. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

⏱️ Dosage and Administration ~3 min read ▾

2. DOSAGE AND ADMINISTRATION Dosage of Ceftaroline Fosamil for Injection by Indication in Adult and Pediatric Patients ( 2.1 , 2.2) Indication Age Range Dosage Infusion Time Duration Acute Bacterial Skin and Skin Structure Infections (ABSSSI) 18 years and older 600 mg every 12 hours 5 to 60 minutes 5 to 14 days ≥2 years to <18 years (> 33 kg) 400 mg every 8 hours OR 600 mg every 12 hours 5 to 60 minutes 5 to 14 days ≥2 years to <18 years (≤33kg) 12 mg/kg every 8 hours 5 to 60 minutes 5 to 14 days 2 months to <2 years 8 mg/kg every 8 hours 5 to 60 minutes 5 to 14 days 0* to <2 months 6 mg/kg every 8 hours 30 to 60 minutes 5 to 14 days *Gestational age 34 weeks and older and postnatal age 12 days and older Indication Age Range Dosage Infusion Time Duration Community Acquired Bacterial Pneumonia (CABP) 18 years and older 600 mg every12 hours 5 to 60 minutes 5 to 7 days ≥2 years to < 18 years (> 33 kg) 400 mg every 8 hours OR 600 mg every12 hours 5 to 60 minutes 5 to 14 days ≥2 years to < 18 years (≤ 33kg) 12 mg/kg every8 hours 5 to 60 minutes 5 to 14 days 2 months to < 2 years 8 mg/kg every8 hours 5 to 60 minutes 5 to 14 days Dosage adjustment is required in adult patients with creatinine clearance (CrCl) <50 mL/min and in End-stage Renal Disease (ESRD) including hemodialysis ( 2.3 ) There is insufficient information to recommend a dosage regimen for pediatric patients with CrCL <50 mL/min/1.73 m 2 ( 2.3 )

2.1Recommended Dosage in Adult Patients The recommended dosage of ceftaroline fosamil for injection is 600 mg administered every 12 hours by intravenous (IV) infusion over 5 to 60 minutes in patients ≥18 years of age. The duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress. The recommended dosage and administration by infection is described in Table 1.

Table 1: Dosage of Ceftaroline Fosamil for Injection by Indication in Adults Indication Dosage Frequency Infusion Time Recommended Duration of Treatment Acute Bacterial Skin and Skin Structure Infections (ABSSSI) 600 mg Every 12 hours 5 to 60 minutes 5-14 days Community-Acquired Bacterial Pneumonia (CABP) 600 mg Every 12 hours 5 to 60 minutes 5-7 days

2.2Recommended Dosage in Pediatric Patients The recommended dosage of ceftaroline fosamil for injection in pediatric patients is based on the age and weight of the child. The duration of therapy should be guided by the severity, site of infection and the patient’s clinical and bacteriological progress. Pediatric Patients 2 Months of Age and Older For pediatric patients 2 months of age and older, ceftaroline fosamil for injection is administered every 8 hours by intravenous infusion over 5 to 60 minutes.

Ceftaroline fosamil for injection dosing regimen is dependent on the type of infection (ABSSSI, CABP). See dosing Table 2 below. Table 2: Dosage of Ceftaroline Fosamil for Injection by Indication in Pediatric Patients 2 Months of Age and Older Indication Age Range Dosage and Frequency Infusion time Recommended Duration of Treatment Acute Bacterial Skin and Skin Structure Infections (ABSSSI) OR Community-Acquired Bacterial Pneumonia (CABP) 2 months to < 2 years 8 mg/kg every 8 hours 5 to 60 minutes 5-14 days ≥ 2 years to < 18 years (≤ 33 kg) 12 mg/kg every 8 hours ≥ 2 years to < 18 years (> 33 kg) 400 mg every 8 hours OR 600 mg every 12 hours Pediatric Patients Less Than 2 Months of Age Ceftaroline fosamil for injection are administered every 8 hours by intravenous infusion over 30 to 60 minutes for patients less than 2 months of age.

Ceftaroline fosamil for injection dosing regimen is only recommended for patients with ABSSSI. See dosing Table 3 below. Concentrations of ceftaroline fosamil in the cerebrospinal fluid have not been evaluated [see Use in Specific Populations ( 8.4 )].

There is no information for dosing ceftaroline fosamil for injection in infants less than 34 weeks gestational age and less than 12 days postnatal age. Table 3: Dosage of Ceft… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 83 words ▾

3. DOSAGE FORMS AND STRENGTHS For Injection: Ceftaroline fosamil for injection is supplied as 600 mg or 400 mg of sterile ceftaroline fosamil (equivalent to 653 mg and 435 mg, respectively, of ceftaroline fosamil monoacetate) powder in single-dose, 20 mL clear glass vials. The powder is constituted and further diluted for intravenous injection.

For Injection: 600 mg or 400 mg of sterile ceftaroline fosamil powder in single-dose 20 mL vials. The powder is constituted and further diluted for intravenous injection. ( 3 )

⛔ Contraindications 44 words ▾

4. CONTRAINDICATIONS Ceftaroline fosamil for injection is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis has been reported with ceftaroline. Known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5. WARNINGS AND PRECAUTIONS Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterial drugs, including ceftaroline. If a hypersensitivity reaction occurs, discontinue ceftaroline fosamil for injection.

( 5.1 ) Clostridiodes difficile -associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ceftaroline fosamil for injection. Evaluate if diarrhea occurs. ( 5.2 ) Neurological adverse reactions have been reported in patients treated with cephalosporins, including ceftaroline.

If neurological adverse reactions occur, consider discontinuing ceftaroline fosamil for injection or making appropriate dosage adjustments in patients with renal impairment. ( 2.3 , 5.3 ) Direct Coombs’ test seroconversion has been reported with ceftaroline. If anemia develops during or after therapy, a diagnostic workup for drug- induced hemolytic anemia should be performed and consideration given to discontinuation of ceftaroline fosamil for injection.

( 5.4 )

5.1Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with ceftaroline fosamil for injection is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. Maintain clinical supervision if this product is to be given to a penicillin- or other beta-lactam-allergic patient, because cross sensitivity among beta-lactam antibacterial agents has been clearly established.

If an allergic reaction to ceftaroline fosamil for injection occurs, discontinue ceftaroline fosamil for injection and institute appropriate treatment and supportive measures.

5.2Clostridioides difficile - Associated Diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including ceftaroline fosamil for injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, antibacterials not directed against C. difficile should be discontinued, if possible. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated [see Adverse Reactions ( 6.1 )].

5.3Neurological Adverse Reactions Neurological adverse reactions have been reported during postmarketing surveillance in patients treated with cephalosporins, including ceftaroline fosamil for injection. These reactions include encephalopathy and seizures [see Adverse Reactions ( 6.2 )] . Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment.

The neurological adverse reactions were reversible and resolved after discontinuation of ceftaroline fosamil for injection or after hemodialysis. If neurological adverse reactions associated with ceftaroline fosamil for injection therapy occur, consider discontinuing ceftaroline fosamil for injection or making appropriate dosage adjustments in patients with renal impairment [see Dosage and Administration ( 2.3 )] .

5.4Direct Coombs' Test Seroconversion Seroconversion from a negative to a positive direct Coombs’ test result occurred in 120/1,114 (10.8%) o… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6. ADVERSE REACTIONS The following serious adverse reactions are described in greater detail in the Warnings and Precautions section Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Clostridioides difficile -Associated diarrhea [see Warnings and Precautions ( 5.2 )] Neurological Adverse Reactions [see Warnings and Precautions ( 5.3 )] Direct Coombs’ Test Seroconversion [see Warnings and Precautions ( 5.4 )] The most common adverse reactions occurring in >2 % of adult patients and ≥3% of pediatric patients are diarrhea, nausea, and rash.

Additional adverse reactions that occurred in ≥3% of pediatric patients include vomiting and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be compared directly to rates from clinical trials of another drug and may not reflect rates observed in practice. Adult Patients Ceftaroline fosamil for injection was evaluated in four controlled comparative Phase 3 clinical trials (two in ABSSSI and two in CABP) which included 1,300 adult patients treated with ceftaroline fosamil for injection (600 mg administered by IV over 1 hour every 12h) and 1,297 patients treated with comparator (vancomycin plus aztreonam or ceftriaxone) for a treatment period up to 21 days.

The median age of patients treated with ceftaroline fosamil for injection was 54 years, ranging between 18 and 99 years old. Patients treated with ceftaroline fosamil for injection were predominantly male (63%) and Caucasian (82%). Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation In the four pooled adult Phase 3 clinical trials, serious adverse reactions (SARs) occurred in 98/1,300 (7.5%) of patients receiving ceftaroline fosamil for injection and 100/1,297 (7.7%) of patients receiving comparator drugs.

Treatment discontinuation due to adverse reactions occurred in 35/1,300 (2.7%) of patients receiving ceftaroline fosamil for injection and 48/1,297 (3.7%) of patients receiving comparator drugs with the most common adverse reactions leading to discontinuation being hypersensitivity for both treatment groups at a rate of 0.3% in the ceftaroline fosamil for injection group and 0.5% in comparator group. Most Common Adverse Reactions No adverse reactions occurred in greater than 5% of adult patients receiving ceftaroline fosamil for injection.

The most common adverse reactions occurring in > 2% of patients receiving ceftaroline fosamil for injection in the pooled adult phase 3 clinical trials were diarrhea, nausea, and rash. Table 6 lists adverse reactions occurring in ≥ 2% of patients receiving ceftaroline fosamil for injection in the pooled adult Phase 3 clinical trials. Table 6: Adverse Reactions Occurring in ≥ 2% of Patients Receiving Ceftaroline Fosamil for Injection in the Pooled Adult Phase 3 Clinical Trials Adverse Reactions Pooled Phase 3 Clinical Trials (four trials, two in ABSSSI and two in CABP) Ceftaroline Fosamil for Injection (N=1,300) Pooled Comparators a (N=1,297) Gastrointestinal Disorders Diarrhea 5 % 3 % Nausea 4 % 4 % Constipation 2 % 2 % Vomiting 2 % 2 % Laboratory Investigations Increased transaminases 2% 3 % Metabolism and Nutrition disorders Hypokalemia 2 % 3 % Skin and Subcutaneous Tissue Disorders Rash 3% 2% Vascular Disorders Phlebitis 2% 1% a Comparators included vancomycin 1 gram IV every 12h plus aztreonam 1 gram IV every 12h in the Phase 3 ABSSSI trials, and ceftriaxone 1 gram IV every 24h in the Phase 3 CABP trials.

Other Adverse Reactions Observed During Clinical Trials of Ceftaroline Fosamil for Injection Following is a list of additional adverse reactions reported by the 1,740 adult patients who received ceftaroline fosamil for injection in any clinical trial with incidences less than 2%. Blood and lymphatic s… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8. USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate studies with ceftaroline fosamil in pregnant women that informed any drug associated risks. Th e background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies within the general population.

In developmental toxicity studies conducted in animals, no malformations or other adverse developmental effects were observed in offspring of rats exposed to ceftaroline fosamil at up to 4 times the maximum recommended human dose (MRHD) during the period of organogenesis through lactation. In rabbits exposed to ceftaroline fosamil during organogenesis at levels approximately equal to the MRHD, no drug-induced fetal malformations were observed despite maternal toxicity. Data Animal Data Developmental toxicity studies performed with ceftaroline fosamil in rats at IV doses up to 300 mg/kg demonstrated no maternal toxicity and no effects on the fetus.

A separate toxicokinetic study showed that ceftaroline exposure in rats (based on AUC) at this dose level was approximately 4 times the exposure in humans given 600 mg every 12 hours. There were no drug-induced malformations in the offspring of rabbits given IV doses of 25, 50, and 100 mg/kg, despite maternal toxicity. Signs of maternal toxicity appeared secondary to the sensitivity of the rabbit gastrointestinal system to broad-spectrum antibacterials and included changes in fecal output in all groups and dose-related reductions in body weight gain and food consumption at > 50 mg/kg; these were associated with an increase in spontaneous abortion at 50 and 100 mg/kg.

The highest dose was also associated with maternal moribundity and mortality. An increased incidence of a common rabbit skeletal variation, angulated hyoid alae, was also observed at the maternally toxic doses of 50 and 100 mg/kg. A separate toxicokinetic study showed that ceftaroline exposure in rabbits (based on AUC) was approximately 0.4 times the exposure in humans given 600 mg every 12 hours at 25 mg/kg and 0.7 times the human exposure at 50 mg/kg.

Ceftaroline fosamil did not affect the postnatal development or reproductive performance of the offspring of rats given IV doses up to 450 mg/kg/day. Results from a toxicokinetic study conducted in pregnant rats with doses up to 300 mg/kg suggest that exposure was ≥ 4 times the exposure in humans given 600 mg every 12 hours.

8.2Lactation Risk Summary No data is available regarding the presence of ceftaroline in human milk, the effects of ceftaroline on breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ceftaroline fosamil and any potential adverse effects on the breastfed child from ceftaroline fosamil or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of ceftaroline fosamil for injection in the treatment of ABSSSI have been established in pediatric patients (at least 34 weeks gestational age and 12 days postnatal age). The safety and effectiveness of ceftaroline fosamil for injection in the treatment of CABP have been established in the age groups 2 months to less than 18 years old. Use of ceftaroline fosamil for injection in these age groups is supported by evidence from adequate and well-controlled studies of ceftaroline fosamil for injection in adults with additional pharmacokinetic and safety data in pediatric patients 2 months of age and older with ABSSSI or CABP [see Clinical Studies ( 14.1 and 14.2)].

Use of ceftaroline fosamil for injection in pediatric patients less than 2 months of age was supported by pharmacokinetic and safety data in 11 infants at least 34 weeks gestational age and 12 days postnatal age. In these infants, concentrations of ceftaroline fosamil for injection in the c… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no adequate studies with ceftaroline fosamil in pregnant women that informed any drug associated risks. Th e background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies within the general population.

In developmental toxicity studies conducted in animals, no malformations or other adverse developmental effects were observed in offspring of rats exposed to ceftaroline fosamil at up to 4 times the maximum recommended human dose (MRHD) during the period of organogenesis through lactation. In rabbits exposed to ceftaroline fosamil during organogenesis at levels approximately equal to the MRHD, no drug-induced fetal malformations were observed despite maternal toxicity. Data Animal Data Developmental toxicity studies performed with ceftaroline fosamil in rats at IV doses up to 300 mg/kg demonstrated no maternal toxicity and no effects on the fetus.

A separate toxicokinetic study showed that ceftaroline exposure in rats (based on AUC) at this dose level was approximately 4 times the exposure in humans given 600 mg every 12 hours. There were no drug-induced malformations in the offspring of rabbits given IV doses of 25, 50, and 100 mg/kg, despite maternal toxicity. Signs of maternal toxicity appeared secondary to the sensitivity of the rabbit gastrointestinal system to broad-spectrum antibacterials and included changes in fecal output in all groups and dose-related reductions in body weight gain and food consumption at > 50 mg/kg; these were associated with an increase in spontaneous abortion at 50 and 100 mg/kg.

The highest dose was also associated with maternal moribundity and mortality. An increased incidence of a common rabbit skeletal variation, angulated hyoid alae, was also observed at the maternally toxic doses of 50 and 100 mg/kg. A separate toxicokinetic study showed that ceftaroline exposure in rabbits (based on AUC) was approximately 0.4 times the exposure in humans given 600 mg every 12 hours at 25 mg/kg and 0.7 times the human exposure at 50 mg/kg.

Ceftaroline fosamil did not affect the postnatal development or reproductive performance of the offspring of rats given IV doses up to 450 mg/kg/day. Results from a toxicokinetic study conducted in pregnant rats with doses up to 300 mg/kg suggest that exposure was ≥ 4 times the exposure in humans given 600 mg every 12 hours.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of ceftaroline fosamil for injection in the treatment of ABSSSI have been established in pediatric patients (at least 34 weeks gestational age and 12 days postnatal age). The safety and effectiveness of ceftaroline fosamil for injection in the treatment of CABP have been established in the age groups 2 months to less than 18 years old. Use of ceftaroline fosamil for injection in these age groups is supported by evidence from adequate and well-controlled studies of ceftaroline fosamil for injection in adults with additional pharmacokinetic and safety data in pediatric patients 2 months of age and older with ABSSSI or CABP [see Clinical Studies ( 14.1 and 14.2)].

Use of ceftaroline fosamil for injection in pediatric patients less than 2 months of age was supported by pharmacokinetic and safety data in 11 infants at least 34 weeks gestational age and 12 days postnatal age. In these infants, concentrations of ceftaroline fosamil for injection in the cerebrospinal fluid were not evaluated [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14.2 )]. Results from the clinical studies in pediatric patients show that ceftaroline fosamil for injection demonstrated a safety profile that was comparable with treatment of ABSSSI and CABP in adults at the clinical dosages studied.

Safety and effectiveness of ceftaroline fosamil for injection in pediatric patients less than 34 weeks gestational age and less than 12 days postnatal age for the treatment of ABSSSI have not been established. Safety and effectiveness of ceftaroline fosamil for injection in pediatric patients below the age of 2 months for the treatment of CABP have not been established as no data are available.

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Of the 1,300 adult patients treated with ceftaroline fosamil for injection in the Phase 3 ABSSSI and CABP trials, 397 (30.5%) were ≥ 65 years of age. The clinical cure rates in the ceftaroline fosamil for injection group (Clinically Evaluable [CE] Population) were similar in patients ≥ 65 years of age compared with patients < 65 years of age in both the ABSSSI and CABP trials. The adverse reaction profiles in patients ≥ 65 years of age and in patients < 65 years of age were similar.

The percentage of patients in the ceftaroline fosamil for injection group who had at least one adverse reaction was 52.4% in patients ≥ 65 years of age and 42.8% in patients < 65 years of age for the two indications combined. Ceftaroline is excreted primarily by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group and it may be useful to monitor renal function.

Elderly subjects had greater ceftaroline exposure relative to non-elderly subjects when administered the same single dose of ceftaroline fosamil for injection. However, higher exposure in elderly subjects was mainly attributed to age-related changes in renal function. Dosage adjustment for elderly patients should be based on renal function [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )].

🆘 Overdosage 117 words ▾

10. OVERDOSAGE Ceftaroline fosamil for injection overdosage has occurred in patients with renal impairment. Reactions have included neurological sequelae, including encephalopathy [see Dosage and Administration (2.3), Warnings and Precautions ( 5.3 ) and Adverse Reactions (6.2)].

In the event of overdose, ceftaroline fosamil for injection should be discontinued and general supportive treatment given. Ceftaroline can be removed by hemodialysis. In subjects with ESRD administered 400 mg of ceftaroline fosamil for injection, the mean total recovery of ceftaroline in the dialysate following a 4-hour hemodialysis session started 4 hours after dosing was 76.5 mg (21.6% of the dose).

However, no information is available on the use of hemodialysis to treat overdosage [see Clinical Pharmacology ( 12.3 )] .

🧬 Clinical Pharmacology ~3 min read ▾

12. CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ceftaroline is a cephalosporin antibacterial drug [see Microbiology ( 12.4 )] .

12.2Pharmacodynamics As with other beta-lactam antimicrobial agents, the time that unbound plasma concentration of ceftaroline exceeds the minimum inhibitory concentration (MIC) of the infecting organism has been shown to best correlate with efficacy in a neutropenic murine thigh infection model with S. aureus and S. pneumoniae . Exposure-response analysis of Phase 2/3 ABSSSI trials supports the recommended dosage regimen of ceftaroline fosamil for injection 600 mg every 12 hours by IV infusion over 1 hour. For Phase 3 CABP trials, an exposure-response relationship could not be identified due to the limited range of ceftaroline exposures in the majority of patients.

Cardiac Electrophysiology In a randomized, positive- and placebo-controlled crossover thorough QTc study, 54 healthy subjects were each administered a single dose of ceftaroline fosamil for injection 1,500 mg, placebo, and a positive control by IV infusion over 1 hour. At the 1,500 mg dose of ceftaroline fosamil for injection, no significant effect on QTc interval was detected at peak plasma concentration or at any other time.

12.3Pharmacokinetics The mean pharmacokinetic parameters of ceftaroline in healthy adults (n=6) with normal renal function after single and multiple 1-hour IV infusions of 600 mg ceftaroline fosamil administered every 12 hours are summarized in Table 8. Pharmacokinetic parameters were similar for single and multiple dose administration. Table 8: Mean (Standard Deviation) Pharmacokinetic Parameters of Ceftaroline IV in Healthy Adults Parameter Single 600 mg Dose Administered as a 1-Hour Infusion (n=6) Multiple 600 mg Doses Administered Every 12 Hours as 1-Hour Infusions for 14 Days (n=6) C max (mcg/mL) 19.0 (0.71) 21.3 (4.10) T max (h) a 1 .00 (0.92-1.25) 0.92 (0.92-1.08) AUC (mcg•h/mL) b 56.8 (9.31) 56.3 (8.90) T 1/2 (h) 1.60 (0.38) 2.66 (0.40) CL (L/h) 9.58 (1.85) 9.60 (1.40) a Reported as median (range) b AUC 0-∞ , for single-dose administration; AUC 0-tau , for multiple-dose administration; C max , maximum observed concentration; T max , time of C max ; AUC 0-∞ , area under concentration-time curve from time 0 to infinity; AUC 0-tau , area under concentration-time curve over dosing interval (0-12 hours); T 1/2 , terminal elimination half-life; CL, plasma clearance The C max and AUC of ceftaroline increase approximately in proportion to dose within the single dose range of 50 to 1,000 mg.

No appreciable accumulation of ceftaroline is observed following multiple IV infusions of 600 mg administered every 12 hours for up to 14 days in healthy adults with normal renal function. The systemic exposure (AUC), T 1/2 , and clearance of ceftaroline were similar following administration of 600 mg ceftaroline fosamil in a volume of 50 mL to healthy subjects every 8 hours for 5 days as a 5-minute or 60-minute infusion, and the T max of ceftaroline occurred about 5 minutes after the end of the ceftaroline fosamil infusion for both infusion durations.

The mean (SD) C max of ceftaroline was 32.5 (4.82) mcg/mL for the 5-minute infusion duration (n=11) and 17.4 (3.87) mcg/mL for the 60-minute infusion duration (n=12). Distribution The average binding of ceftaroline to human plasma proteins is approximately 20% and decreases slightly with increasing concentrations over 1 to 50 mcg/mL (14.5 to 28%). The median (range) steady-state volume of distribution of ceftaroline in healthy adult males (n=6) following a single 600 mg IV dose of radiolabeled ceftaroline fosamil was

20.3L (18.3 to

21.6L), similar to extracellular fluid volume. Elimination Metabolism Ceftaroline fosamil is the water-soluble prodrug of the bioactive ceftaroline. Ceftaroline fosamil is converted into bioactive ceftaroline in plasma by a phosphatase enzyme and concentrations of the prodrug are measurable in plasma primarily during IV infusion. Hydrolysis of the… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 16 words ▾

12.1Mechanism of Action Ceftaroline is a cephalosporin antibacterial drug [see Microbiology ( 12.4 )] .

📦 How Supplied / Storage and Handling 71 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING Ceftaroline Fosamil for Injection is supplied in single-dose, clear glass vials containing: 400 mg - individual vial (NDC 60505-6124-0) and carton containing 10 vials (NDC 60505-6124-1) 600 mg - individual vial (NDC 60505-6125-0) and carton containing 10 vials (NDC 60505-6125-1) Ceftaroline fosamil for injection vials (unreconstituted) should be stored at 25°C (77°F); excursions permitted to 15ºC to 30ºC (59°F to 86°F) [See USP Controlled Room Temperature].

📋 Description 186 words ▾

11. DESCRIPTION Ceftaroline fosamil for injection is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β- lactams). Chemically, the prodrug, ceftaroline fosamil monoacetate is (6 R ,7 R )-7-{(2 Z )-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4- yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate.

Its molecular weight is 744.74. The molecular formula is C 22 H 21 N 8 O 8 PS 4 . CH 3 COOH.

Figure 1: Chemical structure of ceftaroline fosamil Ceftaroline fosamil for injection vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 653 mg and 435 mg, respectively, of ceftaroline fosamil monoacetate). The powder for injection is formulated from ceftaroline fosamil monoacetate, a yellow white to light yellow powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 264 mg/vial as buffering agent.

Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 396 mg/vial as buffering agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration ( 2.3 )] .

The pH of the constituted solution is 4.8 to 6.5.

💬 Information for Patients ~2 min read ▾

17. PATIENT COUNSELING INFORMATION Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. They should inform their healthcare provider about any previous hypersensitivity reactions to ceftaroline fosamil for injection, other beta-lactams (including cephalosporins) or other allergens.

Advise patients that neurological adverse reactions could occur with ceftaroline fosamil for injection use. Instruct patients or their caregivers to inform their healthcare provider at once of any neurological signs and symptoms, including encephalopathy (disturbance of consciousness including somnolence, lethargy, confusion, and slow thinking), and seizures for immediate treatment, dosage adjustment, or discontinuation of ceftaroline fosamil for injection. Patients should be counseled that antibacterial drugs including ceftaroline fosamil for injection should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold). When ceftaroline fosamil for injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ceftaroline fosamil for injection or other antibacterial drugs in the future.

Advise patients that diarrhea is a common problem caused by antibacterial drugs, including ceftaroline fosamil for injection and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, patients should contact their healthcare provider.

Ceftaroline Fosamil for Injection 400 mg and 600 mg Manufactured by: Manufactured for: Qilu Pharmaceutical Co., Ltd. Apotex Corp. High Tech Zone Weston, Florida Jinan, 250101, China USA, 33326 Manufactured by: QILU Antibiotics Pharmaceutical Co., Ltd.

Jinan, 250105, China All registered trademarks in this document are the property of their respective owners. Revised: March 2026 Rev. 1

🍼 Nursing Mothers 66 words ▾

8.2Lactation Risk Summary No data is available regarding the presence of ceftaroline in human milk, the effects of ceftaroline on breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ceftaroline fosamil and any potential adverse effects on the breastfed child from ceftaroline fosamil or from the underlying maternal condition.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The mean pharmacokinetic parameters of ceftaroline in healthy adults (n=6) with normal renal function after single and multiple 1-hour IV infusions of 600 mg ceftaroline fosamil administered every 12 hours are summarized in Table 8. Pharmacokinetic parameters were similar for single and multiple dose administration. Table 8: Mean (Standard Deviation) Pharmacokinetic Parameters of Ceftaroline IV in Healthy Adults Parameter Single 600 mg Dose Administered as a 1-Hour Infusion (n=6) Multiple 600 mg Doses Administered Every 12 Hours as 1-Hour Infusions for 14 Days (n=6) C max (mcg/mL) 19.0 (0.71) 21.3 (4.10) T max (h) a 1 .00 (0.92-1.25) 0.92 (0.92-1.08) AUC (mcg•h/mL) b 56.8 (9.31) 56.3 (8.90) T 1/2 (h) 1.60 (0.38) 2.66 (0.40) CL (L/h) 9.58 (1.85) 9.60 (1.40) a Reported as median (range) b AUC 0-∞ , for single-dose administration; AUC 0-tau , for multiple-dose administration; C max , maximum observed concentration; T max , time of C max ; AUC 0-∞ , area under concentration-time curve from time 0 to infinity; AUC 0-tau , area under concentration-time curve over dosing interval (0-12 hours); T 1/2 , terminal elimination half-life; CL, plasma clearance The C max and AUC of ceftaroline increase approximately in proportion to dose within the single dose range of 50 to 1,000 mg.

No appreciable accumulation of ceftaroline is observed following multiple IV infusions of 600 mg administered every 12 hours for up to 14 days in healthy adults with normal renal function. The systemic exposure (AUC), T 1/2 , and clearance of ceftaroline were similar following administration of 600 mg ceftaroline fosamil in a volume of 50 mL to healthy subjects every 8 hours for 5 days as a 5-minute or 60-minute infusion, and the T max of ceftaroline occurred about 5 minutes after the end of the ceftaroline fosamil infusion for both infusion durations.

The mean (SD) C max of ceftaroline was 32.5 (4.82) mcg/mL for the 5-minute infusion duration (n=11) and 17.4 (3.87) mcg/mL for the 60-minute infusion duration (n=12). Distribution The average binding of ceftaroline to human plasma proteins is approximately 20% and decreases slightly with increasing concentrations over 1 to 50 mcg/mL (14.5 to 28%). The median (range) steady-state volume of distribution of ceftaroline in healthy adult males (n=6) following a single 600 mg IV dose of radiolabeled ceftaroline fosamil was

20.3L (18.3 to

21.6L), similar to extracellular fluid volume. Elimination Metabolism Ceftaroline fosamil is the water-soluble prodrug of the bioactive ceftaroline. Ceftaroline fosamil is converted into bioactive ceftaroline in plasma by a phosphatase enzyme and concentrations of the prodrug are measurable in plasma primarily during IV infusion.

Hydrolysis of the beta-lactam ring of ceftaroline occurs to form the microbiologically inactive, open-ring metabolite ceftaroline M-1. The mean (SD) plasma ceftaroline M-1 to ceftaroline AUC 0-∞ ratio following a single 600 mg IV infusion of ceftaroline fosamil in healthy adults (n=6) with normal renal function is 28% (3.1%). When incubated with pooled human liver microsomes, ceftaroline was metabolically stable (< 12% metabolic turnover), indicating that ceftaroline is not a substrate for hepatic CYP450 enzymes.

Excretion Ceftaroline and its metabolites are primarily eliminated by the kidneys. Following administration of a single 600 mg IV dose of radiolabeled ceftaroline fosamil to healthy male adults (n=6), approximately 88% of radioactivity was recovered in urine and 6% in feces within 48 hours. Of the radioactivity recovered in urine approximately 64% was excreted as ceftaroline and approximately 2% as ceftaroline M-1.

The mean (SD) renal clearance of ceftaroline was 5.56 (0.20) L/h, suggesting that ceftaroline is predominantly eliminated by glomerular filtration. Specific Populations Patients with Renal Impairment Following administration of a single 600 mg IV dose of ceftaroline fosamil for injection, the geometric mean AUC 0-∞ o… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 167 words ▾

12.2Pharmacodynamics As with other beta-lactam antimicrobial agents, the time that unbound plasma concentration of ceftaroline exceeds the minimum inhibitory concentration (MIC) of the infecting organism has been shown to best correlate with efficacy in a neutropenic murine thigh infection model with S. aureus and S. pneumoniae . Exposure-response analysis of Phase 2/3 ABSSSI trials supports the recommended dosage regimen of ceftaroline fosamil for injection 600 mg every 12 hours by IV infusion over 1 hour. For Phase 3 CABP trials, an exposure-response relationship could not be identified due to the limited range of ceftaroline exposures in the majority of patients.

Cardiac Electrophysiology In a randomized, positive- and placebo-controlled crossover thorough QTc study, 54 healthy subjects were each administered a single dose of ceftaroline fosamil for injection 1,500 mg, placebo, and a positive control by IV infusion over 1 hour. At the 1,500 mg dose of ceftaroline fosamil for injection, no significant effect on QTc interval was detected at peak plasma concentration or at any other time.

🔬 Clinical Studies ~3 min read ▾

14. CLINICAL STUDIES

14.1Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Adult Patients A total of 1,396 adults with clinically documented complicated skin and skin structure infection were enrolled in two identical randomized, multi-center, multinational, double-blind, non-inferiority trials (Trials 1 and 2) comparing ceftaroline fosamil for injection (600 mg administered IV over 1 hour every 12 hours) to vancomycin plus aztreonam (1 g vancomycin administered IV over 1 hour followed by 1 g aztreonam administered IV over 1 hour every 12 hours).

Treatment duration was 5 to 14 days. A switch to oral therapy was not allowed. The Modified Intent-to-Treat (MITT) population included all patients who received any amount of study drug according to their randomized treatment group.

The Clinically Evaluable (CE) population included patients in the MITT population who demonstrated sufficient adherence to the protocol. To evaluate the treatment effect of ceftaroline, an analysis was conducted in 797 patients with ABSSSI (such as deep/extensive cellulitis or a wound infection [surgical or traumatic]) for whom the treatment effect of antibacterials may be supported by historical evidence. This analysis evaluated responder rates based on achieving both cessation of lesion spread and absence of fever on Study Day 3 in the following subgroup of patients: Patients with lesion size ≥ 75 cm 2 and having one of the following infection types: Major abscess with ≥ 5 cm of surrounding erythema Wound infection Deep/extensive cellulitis The results of this analysis are shown in Table 9.

Table 9: Clinical Responders at Study Day 3 from Two Adult Phase 3 ABSSSI Trials Ceftaroline Fosamil for Injection n/N (%) Vancomycin/ Aztreonam n/N (%) Treatment Difference (2-sided 95% CI) ABSSSI Trial 1 148/200 (74.0) 135/209 (64.6) 9.4 (0.4, 18.2) ABSSSI Trial 2 148/200 (74.0) 128/188 (68.1) 5.9 (-3.1, 14.9) The protocol-specified analyses included clinical cure rates at the Test of Cure (TOC) (visit 8 to 15 days after the end of therapy) in the co-primary CE and MITT populations (Table 10) and clinical cure rates at TOC by pathogen in the Microbiologically Evaluable (ME) population (Table 11).

However, there are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at a TOC time point. Therefore, comparisons of ceftaroline fosamil for injection to vancomycin plus aztreonam based on clinical response rates at TOC cannot be utilized to establish non-inferiority. Table 10: Clinical Cure Rates at TOC from Two Adult Phase 3 ABSSSI Trials Ceftaroline Fosamil for Injection n/N (%) Vancomycin/ Aztreonam n/N (%) Treatment Difference (2-sided 95% CI) Trial 1 CE 288/316 (91.1) 280/300 (93.3) -2.2 (-6.6, 2.1) MITT 304/351 (86.6) 297/347 (85.6) 1.0 (-4.2, 6.2) Trial 2 CE 271/294 (92.2) 269/292 (92.1) 0.1 (-4.4., 4.5) MITT 291/342 (85.1) 289/338 (85.5) -0.4 (-5.8, 5.0) Table 11: Clinical Cure Rates at TOC by Pathogen from Two Adult Integrated Phase 3 ABSSSI Trials Ceftaroline Fosamil for Injection n/N (%) Vancomycin/Aztreonam n/N (%) Gram-positive: MSSA (methicillin-susceptible) MRSA (methicillin-resistant) 212/228 (93.0%) 142/152 (93.4%) 225/238 (94.5%) 115/122 (94.3%) Streptococcus pyogenes 56/56 (100%) 56/58 (96.6%) Streptococcus agalactiae 21/22 (95.5%) 18/18 (100%) Gram-negative: Escherichia coli 20/21 (95.2%) 19/21 (90.5%) Klebsiella pneumoniae 17/18 (94.4%) 13/14 (92.9%) Klebsiella oxytoca 10/12 (83.3%) 6/6 (100%) Of the 693 patients in the MITT population in the ceftaroline fosamil for injection arm in the two ABSSSI trials, 20 patients had baseline S. aureus bacteremia (nine MRSA and eleven MSSA).

Thirteen of these twenty patients (65%) were clinical responders for ABSSSI at Study Day 3 and 18/20 (90%) were considered clinical success for ABSSSI at TOC. Pediatric Patients The ABSSSI pediatric trial was a randomized, parallel-group, active controlled trial in pediatric patients 2 months to < 18 y… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 148 words ▾

13. NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies have not been conducted with ceftaroline. Ceftaroline fosamil did not show evidence of mutagenic activity in in vitro tests that included a bacterial reverse mutation assay and the mouse lymphoma assay. Ceftaroline was not mutagenic in an in vitro mammalian cell assay.

In vivo , ceftaroline fosamil did not induce unscheduled DNA synthesis in rat hepatocytes and did not induce the formation of micronucleated erythrocytes in mouse or rat bone marrow. Both ceftaroline fosamil and ceftaroline were clastogenic in the absence of metabolic activation in an in vitro chromosomal aberration assays, but not in the presence of metabolic activation. IV injection of ceftaroline fosamil had no adverse effects on fertility of male and female rats given up to 450 mg/kg.

This is approximately 4-fold higher than the maximum recommended human dose based on body surface area.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 145 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies have not been conducted with ceftaroline. Ceftaroline fosamil did not show evidence of mutagenic activity in in vitro tests that included a bacterial reverse mutation assay and the mouse lymphoma assay. Ceftaroline was not mutagenic in an in vitro mammalian cell assay.

In vivo , ceftaroline fosamil did not induce unscheduled DNA synthesis in rat hepatocytes and did not induce the formation of micronucleated erythrocytes in mouse or rat bone marrow. Both ceftaroline fosamil and ceftaroline were clastogenic in the absence of metabolic activation in an in vitro chromosomal aberration assays, but not in the presence of metabolic activation. IV injection of ceftaroline fosamil had no adverse effects on fertility of male and female rats given up to 450 mg/kg.

This is approximately 4-fold higher than the maximum recommended human dose based on body surface area.

📄 Recent Major Changes 3 words ▾

RECENT MAJOR CHANGES

📄 Package Label / Principal Display Panel 176 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION Representative sample of labeling (see HOW SUPPLIED section for complete listing): PRINCIPAL DISPLAY PANEL - 400 mg/vial - Vial Label APOTEX CORP., NDC No. 60505-6124-0 Ceftaroline Fosamil for Injection 400 mg/vial Rx Only High Tech Zone Antibiotic Site

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION Representative sample of labeling (see HOW SUPPLIED section for complete listing): PRINCIPAL DISPLAY PANEL - 400 mg/vial - Carton Label APOTEX CORP., NDC No. 60505-6124-1 Ceftaroline Fosamil for Injection 400 mg/vial Rx Only High Tech Zone Antibiotic Site

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION Representative sample of labeling (see HOW SUPPLIED section for complete listing): PRINCIPAL DISPLAY PANEL - 600 mg/vial - Vial Label APOTEX CORP., NDC No. 60505-6125-0 Ceftaroline Fosamil for Injection 600 mg/vial Rx Only High Tech Zone Antibiotic Site

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION Representative sample of labeling (see HOW SUPPLIED section for complete listing): PRINCIPAL DISPLAY PANEL - 600 mg/vial - Carton Label APOTEX CORP., NDC No. 60505-6125-1 Ceftaroline Fosamil for Injection 600 mg/vial Rx Only High Tech Zone Antibiotic Site

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 Ceftaroline Fosamil — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Ceftaroline Fosamil. 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.
Total Part D spend
$172.5K
Claims incl. refills
50
Beneficiaries
26
Spend / beneficiary
$6,633.75
Spend / claim
$3,449.55
💵 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.

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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 J0712 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.
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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.