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Meropenem 2 g Injection, Powder, For Solution, 6 vials — NDC 44567-0402-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Meropenem 2 g Injection, Powder, For Solution, 6 vials — NDC 44567-402-06 (Billing 44567-0402-06)

by WG Critical Care, LLC · 6 VIAL in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

This is a package of 6 vials of Meropenem 2 g Injection, Powder, For Solution from WG Critical Care, LLC, marketed since Sep 2023 and currently FDA-listed. It is this product's only package size.

NDC 44567-0402-06
🏷️ FDA NDC (as labeled) 44567-402-06 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 44567-402-06
Product NDC 44567-402
11-digit billing NDC 44567040206
NCPDP billing unit EA — each (per item)
Application # NDA215212
SPL Set ID 240325ba-47a8-4ad1-bcab-6772069ee790
Established class (EPC) Penem Antibacterial
Chemical class Carbapenems
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-09-08
Route INTRAVENOUS
Dosage form INJECTION, POWDER, FOR SOLUTION
Substance MEROPENEM
TE code (Orange Book) AP · RLD · RS

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

GCN Seq No 084896
GCN 54303
HICL code 011254
Ingredient (HICL) Meropenem
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1S
Therapeutic class — specific (HIC3) Carbapenem/Penem Antibiotics
AHFS code 08:12.07.08
AHFS class Carbapenem Antibiotics
FDB label name MEROPENEM 2 GRAM VIAL
FDB brand name Meropenem
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 084896
  • GCN: 54303
  • HICL (First Databank): 011254
  • AHFS class code: 08:12.07.08
Why two NDCs? The FDA registers this code as 44567-402-06 — 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 → 44567-0402-06. 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.

Clinical

Label name MEROPENEM 2 GRAM VIAL Ingredient Meropenem
📖 What it is MedlinePlus · NLM

Meropenem injection is used to treat certain infections caused by bacteria. Meropenem injection is in a class of medications called carbapenem antibiotics. It works by killing bacteria. Antibiotics such as meropenem injection will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's an IV antibiotic for complicated skin infections, complicated infections inside the abdomen like appendicitis or peritonitis, and bacterial meningitis in children 3 months and...
  • A nurse or other professional gives it through a vein, usually every 8 hours, over about 15 to 30 minutes. Your dose depends on your infection and kidney function, so we follow you...
  • The common ones are diarrhea, nausea, vomiting, headache, rash and constipation. You might also notice redness or soreness where the IV goes in. Tell your care team if any bother y...
  • Get help for trouble breathing, facial swelling, a blistering or peeling rash, seizures, muscle pain with dark urine, or severe or watery diarrhea. Diarrhea can show up even weeks...
📖 Read our full Meropenem guide →
7
Nutrient depletion considerations

Meropenem may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Meropenem 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $26.07 —
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2183 $1.408 / J2183 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)44567-402-06
11-digit billing NDC44567-0402-06
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2183
DescriptorINJECTION, MEROPENEM (WG CRITICAL CARE), NOT THERAPEUTICALLY EQUIVALENT TO J2185, 100 MG
Billing units / pkg20 units
How the units are derivedThis package is 6 EA; the HCPCS unit is 100 MG, so one package = 20 billing units.
Medicare Part B spend (2025 (Q1-Q4))$30,935 · 460 claims · $67.25 per claim (all NDCs under J2183)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
44567-0402-06 You're viewing this Main listing 6 VIAL in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 2023-09-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Meropenem 2 gthis 44567-0402-06 WG 6 vials — AP FDA listed —
Meropenem 2 g 72078-0081-06 Mylan 6 injections — AP FDA listed —
Meropenem 2 g 81962-0002-08 BROOKS 6 injections — AP FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Sep 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerWG Critical Care, LLC
Application holderHQ SPECIALTY PHARMA CORP
FDA applicationNDA215212 (NDA)
Labeler code44567
First marketedSep 2023
Product typeHuman Prescription Drug
Portfolio85 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 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Meropenem for Injection is a penem antibacterial indicated for the treatment of bacterial meningitis in pediatric patients 3 months of age and older only. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and other antibacterial drugs, Meropenem for Injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.2 )

1.1Bacterial Meningitis (Pediatric Patients 3 Months of Age and Older Only) Meropenem for Injection is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae , Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae, in pediatric patients 3 months of age and older. Meropenem for injection has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.

1.2Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and other antibacterial drugs, Meropenem for Injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 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 • Pediatric patients 3 months of age and older with bacterial meningitis ( 2.1 ) Recommended Meropenem for Injection Dosage Schedule for Pediatric Patients 3 Months of Age and Older with Bacterial Meningitis and Normal Renal Function (2.1) Type of Infection Dose (mg/kg) Up to a Maximum Dose Dosing Interval Bacterial Meningitis 40 2 grams Every 8 hours - Intravenous infusion is to be given over approximately 15 minutes to 30 minutes. - There is no experience with the use of Meropenem for Injection in pediatric patients with renal impairment.

2.1Recommended Dosage in Pediatric Patients 3 Months of Age and Older with Bacterial Meningitis • For pediatric patients 3 months of age and older with bacterial meningitis, the Meropenem for Injection recommended dosage is 40 mg/kg every 8 hours (maximum dosage is 2 grams every 8 hours). • For pediatric patients weighing over 50 kg administer Meropenem for Injection at a dosage of 2 grams every 8 hours for bacterial meningitis. • Administer diluted Meropenem for Injection as an intravenous infusion over approximately 15 minutes to 30 minutes [see Dosage and Administration ( 2.2 )] . • There is limited safety data available to support the administration of a 40 mg/kg (up to a maximum of 2 grams) intravenous bolus injection. • There is no experience with the use of Meropenem for Injection in pediatric patients with renal impairment [see Clinical Pharmacology ( 12.3 )] .

2.2Preparation and Administration of Meropenem for Injection Preparation Instructions for Intravenous Infusion (Reconstitution and Dilution) • Reconstitute Meropenem for Injection vial (2 grams) with Sterile Water for Injection according to the instructions in Table 1 below. • Shake well to dissolve and let stand until clear. Table 1: Volume of Sterile Water for Injection for Reconstitution of Injection Vials Vial Size Amount of Diluent Added (mL) Approximate Withdrawable Volume (mL) Approximate Average Concentration (mg/mL) 2 grams 40 mL 40 mL 50 mg/mL • Add the resulting reconstituted solution to an intravenous container and further dilute with an appropriate infusion fluid [see Dosage and Administration ( 2.3 ) and ( 2.4 )] . • Discard unused portion. • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

When reconstituted, the solution varies from colorless to yellow depending on the concentration. • Do not use flexible container in series connections. Administration Instructions for Meropenem Intravenous Infusion Solution • Injection vials may be directly reconstituted with a compatible infusion fluid. • Alternatively, an injection vial may be reconstituted, then the resulting solution added to an intravenous container and further diluted with an appropriate infusion fluid [ see Dosage and Administration ( 2.3 ) and ( 2.4 )] . • After reconstitution and/or dilution of Meropenem for Injection, administer the appropriate dose of diluted Meropenem solution as an intravenous infusion over approximately 15 minutes to 30 minutes [see Dosage and Administration ( 2.1 )].

2.3Compatibility Compatibility of Meropenem for Injection with other drugs has not been established. Meropenem for Injection should not be mixed with or physically added to solutions containing other drugs.

2.4Stability and Storage Reconstituted Solution with Sterile Water for Injection Use the reconstituted solution with Sterile Water for Injection immediately. However, re-constituted solutions of Meropenem for Injection maintain satisfactory potency under the conditions described below. Do not freeze reconstituted solutions of Meropenem for Injection.

Reconstituted Solution Diluted with Sodium Chloride Injection, 0.9 % Solutions prepared for infusion (meropenem concentrations ranging from 1 mg/mL to 20 mg/mL) reconstituted with Water for Injection and further diluted with Sodium Chloride Injection 0.9% or reconstituted wit… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 43 words ▾

3 DOSAGE FORMS AND STRENGTHS For Injection: 2 grams of meropenem as a white to light yellow powder in a single-dose vial for reconstitution. Meropenem for Injection: 2 grams of meropenem as a powder in a single-dose vial for reconstitution ( 3 )

⛔ Contraindications 63 words ▾

4 CONTRAINDICATIONS Meropenem for injection is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta (β)-lactams. Known hypersensitivity to product components or other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta (β)-lactams. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactams. ( 5.1 ) • Severe cutaneous adverse reactions have been reported in patients receiving meropenem for injection. ( 5.2 ) • Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue meropenem for injection and initiate appropriate therapy.

( 5.3 ) • Seizures and other adverse CNS experiences have been reported during treatment. ( 5.4 ) • Co-administration of meropenem for injection with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures. ( 5.5 , 7.2 ) • Clostridioides difficile -associated diarrhea (ranging from mild diarrhea to fatal colitis) has been reported.

Evaluate if diarrhea occurs. ( 5.6 ) • In patients with renal dysfunction, thrombocytopenia has been observed ( 5.9 )

5.1Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with β-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another β-lactam.

Before initiating therapy with meropenem for injection, it is important to inquire about previous hypersensitivity reactions to penicillins, cephalosporins, other β-lactams, and other allergens. If an allergic reaction to meropenem for injection occurs, discontinue the drug immediately.

5.2Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme (EM) and acute generalized exanthematous pustulosis (AGEP) have been reported in patients receiving meropenem for injection [ see Adverse Reactions ( 6.2 ) ]. If signs and symptoms suggestive of these reactions appear, meropenem should be withdrawn immediately and an alternative treatment should be considered.

5.3Rhabdomyolysis Rhabdomyolysis has been reported with the use of meropenem [see Adverse Reactions ( 6.2 )] . If signs or symptoms of rhabdomyolysis such as muscle pain, tenderness or weakness, dark urine, or elevated creatine phosphokinase are observed, discontinue meropenem for injection and initiate appropriate therapy.

5.4Seizure Potential Seizures and other adverse CNS experiences have been reported during treatment with meropenem for injection. These experiences have occurred most commonly in patients with CNS disorders (e.g., brain lesions or history of seizures) or with bacterial meningitis and/or compromised renal function [ see Adverse Reactions ( 6.1 ) and Drug Interactions ( 7.2 ) ]. During clinical investigations, 2904 immunocompetent adult patients were treated for non-CNS infections with the overall seizure rate being 0.7% (based on 20 patients with this adverse event).

All meropenem-treated patients with seizures had pre-existing contributing factors. Among these included a prior history of seizures or CNS abnormality and concomitant medications with seizure potential. Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity.

Continue anti-convulsant therapy in patients with known seizure disorders. If focal tremors, myoclonus, or seizures occur, evaluate neurologically, placed on anti-convulsant therapy if not already instituted, and re-examine the dosage of meropenem for injection to determine whether it should be decreased or discontinued.

5.5Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid The concomitant use of meropenem and valproic acid or divalproex sodium is generally not recommended. Case re… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following are discussed in greater detail in other sections of labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Rhabdomyolysis [see Warnings and Precautions ( 5.3 )] • Seizure Potential [see Warnings and Precautions ( 5.4 )] • Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid [see Warnings and Precautions ( 5.5 )] • Clostridioides difficile – Associated Diarrhea [see Warnings and Precautions ( 5.6 )] • Development of Drug-Resistant Bacteria [see Warnings and Precautions ( 5.7 )] • Overgrowth of Nonsusceptible Organisms [see Warnings and Precautions ( 5.8 )] • Thrombocytopenia [see Warnings and Precautions ( 5.9 )] • Potential for Neuromotor Impairment [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (incidence ≥ 1%) are diarrhea, rash (mostly diaper area moniliasis), oral moniliasis, and glossitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care, LLC at 1-866-562-4708 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 reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Pediatric Patients with Bacterial Meningitis Meropenem for injection was studied in 321 pediatric patients (3 months to less than 17 years of age) with bacterial meningitis at a dosage of 40 mg/kg every 8 hours.

The most common adverse reactions and their rates of occurrence were as follows: Diarrhea 4.7% Rash (mostly diaper area moniliasis) 3.1% Oral Moniliasis 1.9% Glossitis 1% In these studies, the rates of seizure activity during therapy were comparable between patients with no CNS abnormalities who received meropenem for injection and those who received comparator agents (either cefotaxime or ceftriaxone). In the meropenem for injection-treated group, 12/15 patients with seizures had late onset seizures (seizures that occurred on day 3 or later) versus 7/20 patients in the comparator arm.

The meropenem for injection group had a statistically higher number of patients than the comparator with transient elevation of liver enzymes. Adverse Reactions from Studies of Meropenem for Injection in Other Serious Bacterial Infections (not bacterial meningitis) The following adverse reactions occurred in studies of 2,904 immunocompetent adult patients who received meropenem for injection (500 mg or 1 gram every 8 hours) for the treatment of other serious bacterial infections (not bacterial meningitis). This meropenem for injection product is indicated only for the treatment of bacterial meningitis caused by certain organisms in pediatric patients 3 months of age and older [see Indications and Usage ( 1.1 )].

Many patients in these studies were severely ill and had multiple background diseases, physiological impairments and were receiving multiple other drug therapies. In the seriously ill patient population, it was not possible to determine the relationship between observed adverse events and therapy with meropenem for injection. Deaths in 5 patients were assessed as possibly related to meropenem for injection; 36 (1.2%) patients had meropenem for injection discontinued because of adverse events.

Local Adverse Reactions Local adverse reactions that were reported with meropenem for injection were as follows: Inflammation at the injection site (2.4%), injection site reaction (0.9%), phlebitis/thrombophlebitis (0.8%), pain at the injection site (0.4%), and edema at the injection site (0.2%). Systemic Adverse Reactions Systemic adverse reactions that occurred in greater than 1% of the meropenem for injection-treated patients were diarrhea (4.8%), nausea/vomiting (3.6%), headache (2.3%), rash (1.9%), sepsis (1.6%), cons… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 218 words ▾

7 DRUG INTERACTIONS • Co-administration of meropenem for injection with probenecid inhibits renal excretion of meropenem and therefore Meropenem for Injection is not recommended ( 7.1 ) • The concomitant use of Meropenem for Injection and valproic acid or divalproex sodium is generally not recommended. Antibacterial drugs other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. ( 5.4 , 7.2 )

7.1Probenecid Probenecid competes with meropenem for active tubular secretion, resulting in increased plasma concentrations of meropenem. Co-administration of probenecid with meropenem is not recommended.

7.2Valproic Acid Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Although the mechanism of this interaction is unknown, data from in vitro and animal studies suggest that carbapenems may inhibit the hydrolysis of valproic acid’s glucuronide metabolite (VPA-g) back to valproic acid, thus decreasing the serum concentrations of valproic acid.

If administration of meropenem for injection is necessary, then supplemental anti-convulsant therapy should be considered [ see Warnings and Precautions ( 5.4 ) ].

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are insufficient human data to establish whether there is a drug-associated risk of major birth defects or miscarriages with meropenem in pregnant women. No fetal toxicity or malformations were observed in pregnant rats and Cynomolgus monkeys administered intravenous meropenem during organogenesis at doses up to 2.4 and 2.3 times the maximum recommended human dose (MRHD) based on body surface area comparison, respectively. In rats administered intravenous meropenem in late pregnancy and during the lactation period, there were no adverse effects on offspring at doses equivalent to approximately 3.2 times the MRHD based on body surface area comparison ( see Data ).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Meropenem administered to pregnant rats during organogenesis (Gestation Day 6 to Gestation Day 17) in intravenous doses of 240, 500, and 750 mg/kg/day was associated with mild maternal weight loss at all doses, but did not produce malformations or fetal toxicity. The no-observed-adverse-effect-level (NOAEL) for fetal toxicity in this study was considered to be the high dose of 750 mg/kg/day (equivalent to approximately 2.4 times the MRHD of 1 gram every 8 hours based on body surface area comparison). Meropenem administered intravenously to pregnant Cynomolgus monkeys during organogenesis from Day 20 to 50 after mating at doses of 120, 240, and 360 mg/kg/day did not produce maternal or fetal toxicity at the NOAEL dose of 360 mg/kg/day (approximately 2.3 times the MRHD based on body surface area comparison).

In a peri-postnatal study in rats described in the published literature 1 , intravenous meropenem was administered to dams from Gestation Day 17 until Lactation Day 21 at doses of 240, 500, and 1000 mg/kg/day. There were no adverse effects in the dams and no adverse effects in the first generation offspring (including developmental, behavioral, and functional assessments and reproductive parameters) except that female offspring exhibited lowered body weights which continued during gestation and nursing of the second generation offspring.

Second generation offspring showed no meropenem-related effects. The NOAEL value was considered to be 1000 mg/kg/day (approximately 3.2 times the MRHD based on body surface area comparisons).

8.2Lactation Risk Summary Meropenem has been reported to be excreted in human milk. No information is available on the effects of meropenem on the breast-fed child or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for meropenem for injection and any potential adverse effects on the breast-fed child from meropenem for injection or from the underlying maternal conditions.

8.4Pediatric Use The safety and effectiveness of Meropenem for Injection have been established for pediatric patients 3 months of age and older for the treatment of bacterial meningitis caused by Haemophilus influenzae , Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae , and the information on this use is discussed throughout the labeling. The safety and effectiveness of Meropenem for Injection have not been established in pediatric patients younger than 3 months of age.

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are insufficient human data to establish whether there is a drug-associated risk of major birth defects or miscarriages with meropenem in pregnant women. No fetal toxicity or malformations were observed in pregnant rats and Cynomolgus monkeys administered intravenous meropenem during organogenesis at doses up to 2.4 and 2.3 times the maximum recommended human dose (MRHD) based on body surface area comparison, respectively. In rats administered intravenous meropenem in late pregnancy and during the lactation period, there were no adverse effects on offspring at doses equivalent to approximately 3.2 times the MRHD based on body surface area comparison ( see Data ).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Meropenem administered to pregnant rats during organogenesis (Gestation Day 6 to Gestation Day 17) in intravenous doses of 240, 500, and 750 mg/kg/day was associated with mild maternal weight loss at all doses, but did not produce malformations or fetal toxicity. The no-observed-adverse-effect-level (NOAEL) for fetal toxicity in this study was considered to be the high dose of 750 mg/kg/day (equivalent to approximately 2.4 times the MRHD of 1 gram every 8 hours based on body surface area comparison). Meropenem administered intravenously to pregnant Cynomolgus monkeys during organogenesis from Day 20 to 50 after mating at doses of 120, 240, and 360 mg/kg/day did not produce maternal or fetal toxicity at the NOAEL dose of 360 mg/kg/day (approximately 2.3 times the MRHD based on body surface area comparison).

In a peri-postnatal study in rats described in the published literature 1 , intravenous meropenem was administered to dams from Gestation Day 17 until Lactation Day 21 at doses of 240, 500, and 1000 mg/kg/day. There were no adverse effects in the dams and no adverse effects in the first generation offspring (including developmental, behavioral, and functional assessments and reproductive parameters) except that female offspring exhibited lowered body weights which continued during gestation and nursing of the second generation offspring.

Second generation offspring showed no meropenem-related effects. The NOAEL value was considered to be 1000 mg/kg/day (approximately 3.2 times the MRHD based on body surface area comparisons).

🧒 Pediatric Use 75 words ▾

8.4Pediatric Use The safety and effectiveness of Meropenem for Injection have been established for pediatric patients 3 months of age and older for the treatment of bacterial meningitis caused by Haemophilus influenzae , Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae , and the information on this use is discussed throughout the labeling. The safety and effectiveness of Meropenem for Injection have not been established in pediatric patients younger than 3 months of age.

🆘 Overdosage 158 words ▾

10 OVERDOSAGE In mice and rats, large intravenous doses of meropenem (2200 mg/kg to 4000 mg/kg) have been associated with ataxia, dyspnea, convulsions, and mortalities. Intentional overdosing of meropenem for injection is unlikely, although accidental overdosing might occur if large doses are given to patients with reduced renal function. The largest dose of meropenem administered in clinical trials has been 2 grams given intravenously every 8 hours.

At this dosage, no adverse pharmacological effects or increased safety risks have been observed. Limited postmarketing experience indicates that if adverse events occur following overdosage, they are consistent with the adverse event profile described in the Adverse Reactions section and are generally mild in severity and resolve on withdrawal or dose reduction. Consider symptomatic treatments.

In individuals with normal renal function, rapid renal elimination takes place. Meropenem and its metabolite are readily dialyzable and effectively removed by hemodialysis; however, no information is available on the use of hemodialysis to treat overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Meropenem is an antibacterial drug [ see Microbiology ( 12.4 ) ].

12.2Pharmacodynamics The percentage of time of a dosing interval that unbound plasma concentration of meropenem exceeds the meropenem minimum inhibitory concentration (MIC) against the infecting organism has been shown to best correlate with efficacy in animal and in vitro models of infection.

12.3Pharmacokinetics Plasma Concentrations At the end of a 30-minute intravenous infusion of a single dose of meropenem for injection in healthy volunteers, mean peak plasma concentrations of meropenem are approximately 49 mcg/mL (range 39 to 58) for the 1 gram dose. Following intravenous doses of 500 mg, mean plasma concentrations of meropenem usually decline to approximately 1 mcg/mL at 6 hours after administration. No accumulation of meropenem in plasma was observed with regimens using 1 gram administered every 6 hours in healthy volunteers with normal renal function.

Distribution The plasma protein binding of meropenem is approximately 2%. After a single intravenous dose of meropenem for injection, the highest mean concentrations of meropenem were found in tissues and fluids at 1 hour (0.5 hours to 1.5 hours) after the start of infusion, except where indicated in the tissues and fluids listed in Table 2 below. Table 2: Meropenem Concentrations in Selected Tissues (Highest Concentrations Reported) Tissue Intravenous Dose (gram) Number of Samples Mean [mcg/mL or mcg/(gram)] at 1 hour unless otherwise noted Range [mcg/mL or mcg/(gram)] Endometrium 0.5 7 4.2 1.7 to

10.2Myometrium 0.5 15 3.8 0.4 to

8.1Ovary 0.5 8 2.8 0.8 to

4.8Cervix 0.5 2 7 5.4 to

8.5Fallopian tube 0.5 9 1.7 0.3 to

3.4Skin 0.5 22 3.3 0.5 to

12.6Interstitial fluid obtained from blister fluid 0.5 9 5.5 3.2 to

8.6Skin 1 10 5.3 1.3 to

16.7Interstitial fluid 1 5 26.3 20.9 to

37.4Colon 1 2 2.6 2.5 to

2.7Bile 1 7 14.6 (3 hours) 4 to

25.7 Gall bladder 1 1 -

3.9Peritoneal fluid 1 9 30.2 7.4 to

54.6Lung 1 2 4.8 (2 hours) 1.4 to

8.2Bronchial mucosa 1 7 4.5 1.3 to

11.1Muscle 1 2 6. 1 (2 hours) 5.3 to

6.9Fascia 1 9 8.8 1.5 to 20 Heart valves 1 7 9.7 6.4 to

12.1Myocardium 1 10 15.5 5.2 to

25.5CSF (inflamed) 20 mg/kg in pediatric patients of age 5 months to 8 years 40 mg/kg in pediatric patients of age 1 month to 15 years (Meropenem for Injection is not approved for use in pediatric patients younger than 3 months of age) 8 5 1.1 (2 hours) 3.3 (3 hours) 0.2 to 2.8 0.9 to

6.5CSF (uninflamed) 1 4 0.2 (2 hours) 0.1 to

0.3Elimination In subjects with normal renal function, the elimination half-life of meropenem is approximately 1 hour. The elimination half-life for meropenem was approximately 1.5 hours in pediatric patients 3 months to 2 years of age. Metabolism There is one metabolite of meropenem that is microbiologically inactive.

Excretion Meropenem is primarily excreted unchanged by the kidneys. Approximately 70% (50% to 75%) of the dose is excreted unchanged within 12 hours. A further 28% is recovered as the microbiologically inactive metabolite.

Fecal elimination represents only approximately 2% of the dose. The measured renal clearance and the effect of probenecid show that meropenem undergoes both filtration and tubular secretion. Urinary concentrations of meropenem in excess of 10 mcg/mL are maintained for up to 5 hours after a 500 mg dose.

Specific Populations Patients with Hepatic Impairment A pharmacokinetic study with meropenem for injection in patients with hepatic impairment has shown no effects of liver disease on the pharmacokinetics of meropenem. Patients with Renal Impairment Pharmacokinetic (PK) studies with meopenem for injection in adult patients with renal impairment have shown that the reduction in plasma clearance of meropenem correlates with creatinine clearance. The effect of renal impairment on the PK of meropenem has not been studied in the pediatric patients.

Therefore, there is no experience in pediatric patients with renal… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 16 words ▾

12.1Mechanism of Action Meropenem is an antibacterial drug [ see Microbiology ( 12.4 ) ].

📦 How Supplied / Storage and Handling 95 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Meropenem for Injection is supplied in a single-dose vial containing meropenem as a white to light yellow powder to deliver 2 grams of meropenem for intravenous administration after reconstitution. The dry powder should be stored at 20º C to 25ºC (68º F to 77ºF). Brief exposure to 15ºC to 30ºC (59ºF to 86ºF) is permitted [see USP Controlled Room Temperature].

NDC 44567-402-01 2 gram single-dose injection vial NDC 44567-402-06 2 gram single-dose injection vial packaged in a carton of 6 The container closure is not made with natural rubber latex.

📋 Description 153 words ▾

11 DESCRIPTION Meropenem for Injection contains meropenem a synthetic carbapenem antibacterial. Meropenem is (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C 17 H 25 N 3 O 5 S•3H 2 O with a molecular weight of 437.52.

Its structural formula is: Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. Meropenem for Injection is a white to pale yellow sterile powder for intravenous administration. Each vial contains meropenem equivalent to 2 grams and 416 mg of sodium carbonate, anhydrous.

When re-constituted as instructed Meropenem for Injection will deliver 2 grams of meropenem (on anhydrous basis) and approximately 180 mg of sodium as sodium carbonate (7.8 mEq) [see Dosage and Administration ( 2.2 )]. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Antibacterial Resistance Patients should be counseled that antibacterial drugs including Meropenem for Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Meropenem 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 Meropenem for Injection or other antibacterial drugs in the future [see Warnings and Precautions ( 5.7 )] . Diarrhea Counsel patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug.

If this occurs, patients should contact their physician as soon as possible [ see Warnings and Precautions ( 5.6 ) ]. Risk of Breakthrough Seizures Counsel patients to inform their physician if they are taking valproic acid or divalproex sodium. Valproic acid concentrations in the blood may drop below the therapeutic range upon co-administration with Meropenem for Injection.

If treatment with Meropenem for Injection is necessary and continued, alternative or supplemental anti-convulsant medication to prevent and/or treat seizures may be needed [ see Warnings and Precautions ( 5.4 ) ]. Potential of Neuromotor Impairment Patients receiving Meropenem for Injection on an outpatient basis must be alerted of adverse events such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. Until it is reasonably well established that Meropenem for Injection is well tolerated, patients should not operate machinery or motorized vehicles [ see Warnings and Precautions ( 5.10 ) ].

Manufactured for: WG Critical Care, LLC Paramus, NJ 07652 Made in Italy

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Plasma Concentrations At the end of a 30-minute intravenous infusion of a single dose of meropenem for injection in healthy volunteers, mean peak plasma concentrations of meropenem are approximately 49 mcg/mL (range 39 to 58) for the 1 gram dose. Following intravenous doses of 500 mg, mean plasma concentrations of meropenem usually decline to approximately 1 mcg/mL at 6 hours after administration. No accumulation of meropenem in plasma was observed with regimens using 1 gram administered every 6 hours in healthy volunteers with normal renal function.

Distribution The plasma protein binding of meropenem is approximately 2%. After a single intravenous dose of meropenem for injection, the highest mean concentrations of meropenem were found in tissues and fluids at 1 hour (0.5 hours to 1.5 hours) after the start of infusion, except where indicated in the tissues and fluids listed in Table 2 below. Table 2: Meropenem Concentrations in Selected Tissues (Highest Concentrations Reported) Tissue Intravenous Dose (gram) Number of Samples Mean [mcg/mL or mcg/(gram)] at 1 hour unless otherwise noted Range [mcg/mL or mcg/(gram)] Endometrium 0.5 7 4.2 1.7 to

10.2Myometrium 0.5 15 3.8 0.4 to

8.1Ovary 0.5 8 2.8 0.8 to

4.8Cervix 0.5 2 7 5.4 to

8.5Fallopian tube 0.5 9 1.7 0.3 to

3.4Skin 0.5 22 3.3 0.5 to

12.6Interstitial fluid obtained from blister fluid 0.5 9 5.5 3.2 to

8.6Skin 1 10 5.3 1.3 to

16.7Interstitial fluid 1 5 26.3 20.9 to

37.4Colon 1 2 2.6 2.5 to

2.7Bile 1 7 14.6 (3 hours) 4 to

25.7 Gall bladder 1 1 -

3.9Peritoneal fluid 1 9 30.2 7.4 to

54.6Lung 1 2 4.8 (2 hours) 1.4 to

8.2Bronchial mucosa 1 7 4.5 1.3 to

11.1Muscle 1 2 6. 1 (2 hours) 5.3 to

6.9Fascia 1 9 8.8 1.5 to 20 Heart valves 1 7 9.7 6.4 to

12.1Myocardium 1 10 15.5 5.2 to

25.5CSF (inflamed) 20 mg/kg in pediatric patients of age 5 months to 8 years 40 mg/kg in pediatric patients of age 1 month to 15 years (Meropenem for Injection is not approved for use in pediatric patients younger than 3 months of age) 8 5 1.1 (2 hours) 3.3 (3 hours) 0.2 to 2.8 0.9 to

6.5CSF (uninflamed) 1 4 0.2 (2 hours) 0.1 to

0.3Elimination In subjects with normal renal function, the elimination half-life of meropenem is approximately 1 hour. The elimination half-life for meropenem was approximately 1.5 hours in pediatric patients 3 months to 2 years of age. Metabolism There is one metabolite of meropenem that is microbiologically inactive.

Excretion Meropenem is primarily excreted unchanged by the kidneys. Approximately 70% (50% to 75%) of the dose is excreted unchanged within 12 hours. A further 28% is recovered as the microbiologically inactive metabolite.

Fecal elimination represents only approximately 2% of the dose. The measured renal clearance and the effect of probenecid show that meropenem undergoes both filtration and tubular secretion. Urinary concentrations of meropenem in excess of 10 mcg/mL are maintained for up to 5 hours after a 500 mg dose.

Specific Populations Patients with Hepatic Impairment A pharmacokinetic study with meropenem for injection in patients with hepatic impairment has shown no effects of liver disease on the pharmacokinetics of meropenem. Patients with Renal Impairment Pharmacokinetic (PK) studies with meopenem for injection in adult patients with renal impairment have shown that the reduction in plasma clearance of meropenem correlates with creatinine clearance. The effect of renal impairment on the PK of meropenem has not been studied in the pediatric patients.

Therefore, there is no experience in pediatric patients with renal impairment [see Dosage and Administration ( 2.3 )] . Drug Interaction Studies Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem. Following administration of probenecid with meropenem, the mean systemic exposure increased 56% and the mean elimination half-life increased 38% [see Drug Interactions ( 7.1 )] .

🧬 Pharmacodynamics 43 words ▾

12.2Pharmacodynamics The percentage of time of a dosing interval that unbound plasma concentration of meropenem exceeds the meropenem minimum inhibitory concentration (MIC) against the infecting organism has been shown to best correlate with efficacy in animal and in vitro models of infection.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES

14.1Bacterial Meningitis Four hundred forty-six patients (397 pediatric patients 3 months to less than 17 years of age) were enrolled in 4 separate clinical trials and randomized to treatment with meropenem for injection (n = 225) at a dosage of 40 mg/kg every 8 hours or a comparator drug, i.e., cefotaxime (n = 187) or ceftriaxone (n = 34), at the approved dosing regimens. A comparable number of patients were found to be clinically evaluable (ranging from 61 to 68%) and with a similar distribution of pathogens isolated on initial CSF culture.

A patient was defined as clinically not cured if any one of the following three criteria were met: 1 At the 5-7 week post-completion of therapy visit, the patient had any one of the following: moderate to severe motor, behavior or development deficits; hearing loss of greater than 60 decibels in one or both ears; or blindness. 2 During therapy the patient’s clinical status necessitated the addition of other antibacterial drugs. 3 Either during or post-therapy, the patient developed a large subdural effusion needing surgical drainage, or a cerebral abscess, or a bacteriologic relapse.

Using these criteria, the following efficacy rates were obtained, per organism (noted in Table 3). The values represent the number of patients clinically cured/number of clinically evaluable patients, with the percent cure in parentheses. Sequelae were the most common reason patients were assessed as clinically not cured.

Table 3: Efficacy rates by Pathogen in the Clinically Evaluable Population with Bacterial Meningitis Microorganisms Meropenem for Injection Comparator S. pneumoniae 17/24 (71) 19/30 (63) H. influenzae (+) (+) β-lactamase-producing 8/10 (80) 6/6 (100) H. influenzae (-/NT) (-/NT) non-β-lactamase-producing or not tested 44/59 (75) 44/60 (73) N. meningitidis 30/35 (86) 35/39 (90) Total (including others) 102/131 (78) 108/140 (77) Five patients were found to be bacteriologically not cured, 3 in the comparator group (1 relapse and 2 patients with cerebral abscesses) and 2 in the meropenem for injection group (1 relapse and 1 with continued growth of Pseudomonas aeruginosa ).

With respect to hearing loss, 263 of the 271 evaluable patients had at least one hearing test performed post-therapy. Table 4 shows the degree of hearing loss between the meropenem for injection-treated patients and comparator-treated patients. Table 4: Hearing Loss at Post-Therapy in the Evaluable Population Treated with Meropenem Degree of Hearing Loss (in one or both ears) Meropenem for Injection n = 128 Comparator n = 135 No loss 61% 56% 20 to 40 decibels 20% 24% Greater than 40 to 60 decibels 8% 7% Greater than 60 decibels 9% 10%

🧪 Nonclinical Toxicology 134 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenesis studies have not been performed. Mutagenesis Genetic toxicity studies were performed with meropenem using the bacterial reverse mutation test, the Chinese hamster ovary HGPRT assay, cultured human lymphocytes cytogenic assay, and the mouse micronucleus test. There was no evidence of mutagenic potential found in any of these tests.

Impairment of Fertility In fertility studies, intravenous meropenem was administered to male rats beginning 11 weeks before mating and throughout mating and to female rats from 2 weeks before mating through Gestation Day 7 at doses of 240, 500, and 1000 mg/kg/day. There was no evidence of impaired fertility at doses up to 1000 mg/kg/day (on the basis of body surface area comparison, approximately 3.2 times to the MRHD of 1 gram every 8 hours).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 131 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenesis studies have not been performed. Mutagenesis Genetic toxicity studies were performed with meropenem using the bacterial reverse mutation test, the Chinese hamster ovary HGPRT assay, cultured human lymphocytes cytogenic assay, and the mouse micronucleus test. There was no evidence of mutagenic potential found in any of these tests.

Impairment of Fertility In fertility studies, intravenous meropenem was administered to male rats beginning 11 weeks before mating and throughout mating and to female rats from 2 weeks before mating through Gestation Day 7 at doses of 240, 500, and 1000 mg/kg/day. There was no evidence of impaired fertility at doses up to 1000 mg/kg/day (on the basis of body surface area comparison, approximately 3.2 times to the MRHD of 1 gram every 8 hours).

📚 References 23 words ▾

15 REFERENCES 1. Kawamura S, AW Russell, SJ Freeman, and RA Siddall, 1992, Reproductive and Developmental Toxicity of Meropenem in Rats, Chemotherapy, 40:S238-250.

📄 Recent Major Changes 8 words ▾

Warnings and Precautions, Rhabdomyolysis ( 5.3 ) 12/2024

📄 Package Label / Principal Display Panel 30 words ▾

PRINCIPAL DISPLAY PANEL NDC 44567-402-01 Meropenem for Injection, USP 2 grams per vial For Intravenous Infusion Only Single-Dose Vial – Discard Unused Portion Rx only meropenem 2 gram vial label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
281
Units reimbursed last 4 qtrs
4.2K
Gross reimbursed last 4 qtrs
$110.3K
Avg / prescription
$392.58
Avg / unit
$26.0689
Latest quarter Q1 2026
48Rx
Fee-for-service vs managed care ⓘ
60% FFS 40% MCO
Fee-for-service · 168 Rx Managed care · 113 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 503 units · 5.0 per 100k residents MI New York: 1,003 units · 5.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 153 units · 1.2 per 100k residents IL Indiana: no data reported IN Ohio: 768 units · 6.5 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 950 units · 2.4 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 204 units · 3.3 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 148 units · 7.0 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 503 units · 2.2 per 100k residents FL
Units reimbursed · per 100k residents
1.27.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Mexico 7.0 /100k
2 Ohio 6.5 /100k
3 New York 5.1 /100k
4 Michigan 5.0 /100k
5 Maryland 3.3 /100k
6 California 2.4 /100k
7 Florida 2.2 /100k
8 Illinois 1.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Meropenem — the program that covers self-administered drugs. 16 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 Meropenem. 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
$4.4M
Claims incl. refills
25.4K
Beneficiaries
10.1K
Spend / beneficiary
$436.11
Spend / claim
$173.24
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by WG Critical Care, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
WG Critical Care, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2183 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.
← 44567-0401-10 · WG 44567-0410-24 · WG →
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.