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Meropenem and Sodium Chloride 500 mg/50mL Injection, Solution — NDC 00264-3183-11 package photo
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Meropenem and Sodium Chloride 500 mg/50mL Injection, Solution — NDC 0264-3183-11 (Billing 00264-3183-11)

by B. Braun Medical Inc. · 24 CONTAINER in 1 CASE / 50 mL in 1 CONTAINER

This is a package of Meropenem and Sodium Chloride 500 mg/50mL Injection, Solution from B. Braun Medical Inc., marketed since Apr 2015 and currently FDA-listed. It is this product's only package size.

NDC 00264-3183-11
🏷️ FDA NDC (as labeled) 0264-3183-11 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 0264-3183-11 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0264 labeler · 3183 product · 11 package
Package marketed since
Apr 30, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0264318311 0
Medicaid fills, this package
302 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0264-3183-11
Product NDC 0264-3183
11-digit billing NDC 00264318311
NCPDP billing unit EA — each (per item)
RxCUI 1722934, 1722939
UNII FV9J3JU8B1
Application # NDA202106
SPL Set ID 3b952a55-6ef7-45c8-be21-16eefe37ec2e
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 2015-04-30
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance MEROPENEM

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

GPI-14 16150050052120
GPI class Meropenem-Sodium Chloride
GCN Seq No 074032
GCN 38554
HICL code 018858
Ingredient (HICL) Meropenem-0.9% Sodium Chloride
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-0.9% NACL 500 MG/50
FDB brand name Meropenem-0.9% Nacl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 074032
  • GCN: 38554
  • GPI-14 (Medi-Span): 16150050052120
  • HICL (First Databank): 018858
  • AHFS class code: 08:12.07.08
  • RxCUI (RxNorm): 1722934
Why two NDCs? The FDA registers this code as 0264-3183-11 — a 4-4-2 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 labeler segment → 00264-3183-11. 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 Penem Antibacterial class.

Pharmacologic class Penem Antibacterial
Drug family (ATC) Carbapenems
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 MEROPENEM-0.9% NACL 500 MG/50 Ingredient Meropenem-0.9% Sodium Chloride
📖 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 →

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 $0.5952 $714.24 / 1200 ml
Medicare drug plans payPart D · Q2 2026 $3.77 $4,519.20 / 1200 ml
Medicare Part B allowsASP · J2184 $1.867 / J2184 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)0264-3183-11
11-digit billing NDC00264-3183-11
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ2184
DescriptorINJECTION, MEROPENEM (B. BRAUN) NOT THERAPEUTICALLY EQUIVALENT TO J2185, 100 MG
Billing units / pkg5 units
How the units are derivedThis package is 24 EA; the HCPCS unit is 100 MG, so one package = 5 billing units.
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
00264-3183-11 You're viewing this Main listing 24 CONTAINER in 1 CASE / 50 mL in 1 CONTAINER 2015-04-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Meropenem 500 mg/20mL 00143-9430-10 Hikma 10 vials — AP FDA listed —
Meropenem and Sodium Chloride 500 mg/50mLthis 00264-3183-11 B. 50 ml — — FDA listed —
Meropenem 500 mg/10mL 00409-0222-10 Hospira, 10 vials — AP FDA listed —
Meropenem 500 mg/10mL 00409-1390-51 Hospira, 10 vials — AP FDA listed —
Meropenem 500 mg/20mL 00781-3000-95 Sandoz 10 vials — AP FDA listed —
Meropenem 500 mg/20mL 25021-0160-20 Sagent 10 vials — AP FDA listed —
Meropenem 500 mg 44567-0145-10 WG 10 vials — AP FDA listed —
Meropenem 500 mg 44567-0400-10 WG 10 vials — AP FDA listed —
Meropenem 500 mg/20mL 44647-0032-10 Savior 10 vials — AP FDA listed —
Meropenem 500 mg/20mL 51810-0502-02 Qilu 10 vials — AP FDA listed —
Meropenem 500 mg 55150-0207-20 Eugia 10 vials — AP FDA listed —
Meropenem 500 mg/10mL 63323-0507-21 Fresenius 10 vials — AP FDA listed —
Meropenem 500 mg/20mL 68083-0146-10 Gland 10 vials — AP FDA listed —
Meropenem 500 mg/20mL 70121-1454-07 Amneal 10 vials — AP FDA listed —
Meropenem 500 mg 70594-0075-02 Xellia 10 vials — AP FDA listed —
Meropenem 500 mg/20mL 72485-0411-01 ARMAS 1 vial — AP FDA listed —
Meropenem 500 mg/20mL 72572-0412-10 Civica, 10 vials — AP FDA listed —
Meropenem 500 mg/20mL 72572-0415-10 Civica, 10 vials — AP FDA listed —
Meropenem 500 mg/20mL 81962-0000-01 BROOKS 1 vial — AP FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2015
On the market since
Apr 2015
📍
2026
Currently FDA-listed
11 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

🧪 Avoiding an ingredient? See Meropenem inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 45P3261C7T
    Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
  • 0.45 g / 50 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerB. Braun Medical Inc.
Application holderB BRAUN MEDICAL INC
FDA applicationNDA202106 (NDA)
Labeler code00264
First marketedApr 2015
Product typeHuman Prescription Drug
Portfolio94 products on file

More NDCs from B. Braun Medical Inc. labeler code 00264

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

1 INDICATIONS AND USAGE Meropenem for Injection and Sodium Chloride Injection is a penem antibacterial indicated for the treatment of: Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). ( 1.1 ) Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). ( 1.2 ) Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only).

( 1.3 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and Sodium Chloride Injection and other antibacterial drugs, Meropenem for Injection and Sodium Chloride Injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

1.1Complicated Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of age and older requiring the full adult dose only) Meropenem for Injection and Sodium Chloride Injection is indicated for the treatment of complicated skin and skin structure infections (cSSSI) due to Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae , viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species.

1.2Complicated Intra-abdominal Infections (Adult Patients and Pediatric Patients 3 Months of age and older requiring the full adult dose only) Meropenem for Injection and Sodium Chloride Injection is indicated for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species.

1.3Bacterial Meningitis (Pediatric Patients 3 Months of age and older requiring the full adult dose only) Meropenem for Injection and Sodium Chloride Injection is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae, Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae . Meropenem has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis. For information regarding use in pediatric patients (3 months of age and older) [see Indications and Usage ( 1.1 ), ( 1.2 ) or ( 1.3 ); Dosage and Administration ( 2.3 ), and Adverse Reactions ( 6.1 )].

1.4Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and Sodium Chloride Injection and other antibacterial drugs, Meropenem for Injection and Sodium Chloride 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 Use this formulation of meropenem only in patients who require the entire 500 mg or 1 gram dose and not any fraction thereof. ( 2.1 ) 500 mg every 8 hours by intravenous infusion over 15 to 30 minutes for complicated skin and skin structure infections (cSSSI) for adult patients. When treating infections caused by Pseudomonas aeruginosa , a dose of 1 gram every 8 hours is recommended ( 2.1 ).

1 gram every 8 hours by intravenous infusion over 15 to 30 minutes for intra-abdominal infections for adult patients. ( 2.1 ) Dosage should be reduced in adult patients with renal impairment. If less than a full dose (1 gram or 500 mg) is required, an alternative formulation should be used to avoid risk of overdose.

( 2.2 ) Recommended Meropenem for Injection Dosage Schedule for Adult Patients with Renal Impairment Creatinine Clearance (mL/min) Dose (dependent on type of infection) Dosing Interval greater than 50 Recommended dose (500 mg cSSSI and 1 gram Intra-abdominal infection) Every 8 hours 26-50 Recommended dose Every 12 hours 10-25 One-half recommended dose Every 12 hours less than 10 One-half recommended dose Every 24 hours Meropenem for Injection and Sodium Chloride Injection in the DUPLEX® Container is designed to deliver a 500 mg or 1 gram dose of Meropenem.

To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of Meropenem. Meropenem is not to be used in pediatric patients aged less than three months. There is no experience in pediatric patients with renal impairment.

Pediatric patients 3 months of age and older. ( 2.3 ) Recommended Meropenem for Injection Dosage Schedule for Pediatric Patients with Normal Renal Function Type of Infection Dose (mg/kg) Up to a Maximum Dose Dosing Interval Complicated skin and skin structure 20 mg/kg (or 1 gram for pediatric patients weighing over 50 kg) every 8 hours is recommended when treating complicated skin and skin structure infections caused by P. aeruginosa (2.3). 10 500 mg Every 8 hours Intra-abdominal 20 1 gram Every 8 hours Meningitis 40 2 grams Every 8 hours - Intravenous infusion is to be given over approximately 15 to 30 minutes. - There is no experience in pediatric patients with renal impairment.

2.1Adult Patients Meropenem for Injection and Sodium Chloride Injection in the DUPLEX® Container should be used only in patients who require the entire 500 mg or 1 gram dose and not any fraction thereof. The recommended dose of Meropenem for Injection and Sodium Chloride Injection is 500 mg given every 8 hours for skin and skin structure infections and 1 gram given every 8 hours for intra-abdominal infections. When treating complicated skin and skin structure infections caused by P. aeruginosa , a dose of 1 gram every 8 hours is recommended.

Meropenem for Injection and Sodium Chloride Injection should be administered by intravenous infusion over approximately 15 to 30 minutes.

2.2Use in Adult Patients with Renal Impairment Dosage should be reduced in patients with creatinine clearance of 50 mL/min or less. (See dosing table below.) Dosage should be reduced in renal failure if less than a full dose (1 gram or 500 mg) is required and an alternative formulation should be used to avoid risk of overdose. When only serum creatinine is available, the following formula (Cockcroft and Gault equation) 1 may be used to estimate creatinine clearance.

Males: Creatinine Clearance (mL/min) = Weight (kg) x (140 - age) 72 x serum creatinine (mg/dL) Females: 0.85 x above value Table 1: Recommended Meropenem for Injection Dosage Schedule for Adult Patients With Renal Impairment Creatinine Clearance (mL/min) Dose (dependent on type of infection) Dosing Interval greater than 50 Recommended dose (500 mg cSSSI and 1 gram Intra-abdominal infection) Every 8 hours 26-50 Recommended dose Every 12 hours 10-25 One-half recommended dose Every 12 hours less than 10 One-half recommended dose Every 24 hours There is… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 100 words ▾

3 DOSAGE FORMS AND STRENGTHS Single-dose DUPLEX ® (Dual-chamber) container: 500 mg meropenem for injection USP (as a blend of sterile meropenem trihydrate USP and sterile sodium carbonate USP/NF) and 50 mL of sodium chloride injection USP 1 gram meropenem for injection USP (as a blend of sterile meropenem trihydrate USP and sterile sodium carbonate USP/NF) and 50 mL of sodium chloride injection USP Single-dose DUPLEX ® Container consisting of: 500 mg Meropenem for Injection and 50 mL Sodium Chloride Injection 0.9% ( 3 ) 1 gram Meropenem for Injection and 50 mL Sodium Chloride Injection 0.9% ( 3 )

⛔ Contraindications 68 words ▾

4 CONTRAINDICATIONS Meropenem for Injection and Sodium Chloride 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-lactams. Known hypersensitivity to product components or anaphylactic reactions to beta-lactams. ( 4 ) Contraindicated where the administration of sodium or chloride could be clinically detrimental.

( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactams. ( 5.1 ) Severe cutaneous adverse reactions have been reported in patients receiving meropenem intravenous. Discontinue meropenem immediately if patients experience these signs and symptoms and consider alternative treatment.

( 5.2 ) Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue Meropenem for Injection and Sodium Chloride 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 ) Solutions containing sodium ions should be used with great care, if at all, in patients where the administration of sodium could be detrimental. ( 5.11 )

5.1Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-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 beta-lactam.

Before initiating therapy with Meropenem for Injection and Sodium Chloride Injection, it is important to inquire about previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams, and other allergens. If an allergic reaction to Meropenem for Injection and Sodium Chloride 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 [see Adverse Reactions (6.2) ] . If signs and symptoms suggestive of these reactions appear, Meropenem for Injection and Sodium Chloride Injection 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 Sodium Chloride 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 are included prior history of seizures or CNS abnormality and concomitant medications with seizure potential. Dosage adjustment is recommended in patients with advanced age and/or adult patients with creatinine clearance of 50 mL/min or less [see Dosage and Administration (2.2) ].

Close adherence to the recommended dosage regimens is urged, especia… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 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) ] High Sodium Load [see Warnings and Precautions (5.11) ] Most common adverse reactions (greater than or equal to 2%) are: headache, nausea, constipation, diarrhea, anemia, vomiting, and rash ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact B.

Braun Medical Inc. at 1-800-854-6851 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Adverse Reactions from Clinical Trials 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. Adult Patients: During clinical investigations, 2904 immunocompetent adult patients were treated for non-CNS infections with meropenem for injection (500 mg or 1000 mg every 8 hours). Deaths in 5 patients were assessed as possibly related to meropenem; 36 (1.2%) patients had meropenem discontinued because of adverse events.

Many patients in these trials 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. The following adverse reaction frequencies were derived from the clinical trials in the 2904 patients treated with meropenem for injection.

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% Edema at the injection site 0.2% Systemic Adverse Reactions Systemic adverse events that were reported with meropenem for injection occurring in greater than 1.0% of the patients were diarrhea (4.8%), nausea/vomiting (3.6%), headache (2.3%), rash (1.9%), sepsis (1.6%), constipation (1.4%), apnea (1.3%), shock (1.2%), and pruritus (1.2%).

Additional systemic adverse reactions that were reported with meropenem for injection and occurring in less than or equal to 1.0% but greater than 0.1% of the patients are listed below within each body system in order of decreasing frequency: Bleeding events were seen as follows: gastrointestinal hemorrhage (0.5%), melena (0.3%), epistaxis (0.2%), hemoperitoneum (0.2%). Body as a Whole: pain, abdominal pain, chest pain, fever, back pain, abdominal enlargement, chills, pelvic pain Cardiovascular: heart failure, heart arrest, tachycardia, hypertension, myocardial infarction, pulmonary embolus, bradycardia, hypotension, syncope Digestive System: oral moniliasis, anorexia, cholestatic jaundice/jaundice, flatulence, ileus, hepatic failure, dyspepsia, intestinal obstruction Hemic/Lymphatic: anemia, hypochromic anemia, hypervolemia Metabolic/Nutritional: peripheral edema, hypoxia Nervous System: insomnia, agitation, delirium, confusion, dizziness, seizure, nervousness, paresthesia, hallucinations, somnolence, anxiety, depression, asthenia [see Warnings and Precautions (5.4) and (5.10) ] Respiratory: respiratory disorder, dyspnea, pleural effus… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 208 words ▾

7 DRUG INTERACTIONS Co-administration of Meropenem for Injection with probenecid inhibits renal excretion of meropenem and is therefore not recommended. ( 7.1 ) The concomitant use of Meropenem 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. ( 5.5 , 7.2 )

7.1Probenecid Probenecid competes with meropenem for active tubular secretion, resulting in increased plasma concentrations of meropenem. Coadministration 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 (5.5) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatric use: Meropenem for Injection and Sodium Chloride Injection should not be used in pediatric patients who require less than the full adult dose of meropenem. ( 8.4 ) Renal Impairment: Dose adjustment is necessary, if creatinine clearance is 50 mL/min or less. ( 2.2 , 8.6 )

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 macaques administered intravenous meropenem during organogenesis at doses up to 3.2 and 2.3 times the maximum recommended human dose 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 maximum recommended human dose based on body surface area comparison [see Data] .

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Reproductive studies have been performed with meropenem in rats at doses of up to 1000 mg/kg/day and in cynomolgus monkeys at doses of up to 360 mg/kg/day (on the basis of body surface area comparisons, approximately 3.2 times and 2.3 times higher, respectively, than the maximum recommended human dose of 1 gram every 8 hours).

These studies revealed no evidence of harm to the fetus due to meropenem, although there were slight changes in fetal body weight at doses of 250 mg/kg/day (equivalent to approximately 0.8 times the maximum recommended human dose of 1 gram every 8 hours based on body surface area comparison) and above in rats. In a published study 2 , meropenem administered to pregnant rats from Gestation Day 6 to Gestation Day 17, 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 highest recommended human dose 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 Postpartum Day 21. 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 highest recommended clinical dose 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 breastfed –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 Sodium Chloride Injection in the DUPLEX® Container and any potential adverse effects on the breastfed-child from Meropenem for Injection and Sodium Chloride Injection in the DUPLEX® Container or from the underlying maternal conditions.

8.4Pediatric Use Meropenem for Injection and Sodium Chloride Injection in the DUPLEX® Container is designed to deliver a 500 mg or 1 gram dose of meropenem. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the fu… [Excerpted — this section continues on DailyMed.]

🤰 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 macaques administered intravenous meropenem during organogenesis at doses up to 3.2 and 2.3 times the maximum recommended human dose 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 maximum recommended human dose based on body surface area comparison [see Data] .

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Reproductive studies have been performed with meropenem in rats at doses of up to 1000 mg/kg/day and in cynomolgus monkeys at doses of up to 360 mg/kg/day (on the basis of body surface area comparisons, approximately 3.2 times and 2.3 times higher, respectively, than the maximum recommended human dose of 1 gram every 8 hours).

These studies revealed no evidence of harm to the fetus due to meropenem, although there were slight changes in fetal body weight at doses of 250 mg/kg/day (equivalent to approximately 0.8 times the maximum recommended human dose of 1 gram every 8 hours based on body surface area comparison) and above in rats. In a published study 2 , meropenem administered to pregnant rats from Gestation Day 6 to Gestation Day 17, 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 highest recommended human dose 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 Postpartum Day 21. 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 highest recommended clinical dose based on body surface area comparisons).

🧒 Pediatric Use 187 words ▾

8.4Pediatric Use Meropenem for Injection and Sodium Chloride Injection in the DUPLEX® Container is designed to deliver a 500 mg or 1 gram dose of meropenem. To prevent unintentional overdose, this product should not be used in pediatric patients who require less than the full adult dose of meropenem. Meropenem is not to be used in pediatric patients aged less than three months. [see Dosage and Administration (2.3) ].

Use of meropenem for injection in pediatric patients with bacterial meningitis is supported by evidence from adequate and well-controlled studies in the pediatric population. Use of meropenem for injection in pediatric patients with intra-abdominal infections is supported by evidence from adequate and well-controlled studies with adults with additional data from pediatric pharmacokinetics studies and controlled clinical trials in pediatric patients. Use of meropenem for injection in pediatric patients with complicated skin and skin structure infections is supported by evidence from an adequate and well-controlled study with adults and additional data from pediatric pharmacokinetics studies [see Indications and Usage (1) , Dosage and Administration (2.3) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) and Clinical Studies (14) ].

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Of the total number of subjects in clinical studies of meropenem for injection, approximately 1100 (30%) were 65 years of age and older, while 400 (11%) were 75 years and older. Additionally, in a study of 511 patients with complicated skin and skin structure infections, 93 (18%) were 65 years of age and older, while 38 (7%) were 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects; spontaneous reports and other reported clinical experience have not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Meropenem is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with renal impairment. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. A pharmacokinetic study with meropenem for injection in elderly patients has shown a reduction in the plasma clearance of meropenem that correlates with age-associated reduction in creatinine clearance [see Clinical Pharmacology (12.3) ].

Each 500 mg of Meropenem for Injection and Sodium Chloride Injection delivers 245.1 mg (10.7 mEq) of sodium and each 1 gram of Meropenem for Injection and Sodium Chloride Injection delivers 290.2 mg (12.6 mEq) of sodium. At the usual recommended doses of 500 mg or 1000 mg every 8 hours, patients would receive between 735 mg/day and 870 mg/day (32 mEq and 38 mEq) of sodium. The geriatric population may respond with a blunted natriuresis to salt loading.

This may be clinically important with regard to such diseases as congestive heart failure [see C ontraindications (4) and Warnings and Precautions (5.11) ].

🆘 Overdosage 161 words ▾

10 OVERDOSAGE In mice and rats, large intravenous doses of meropenem (2200-4000 mg/kg) have been associated with ataxia, dyspnea, convulsions, and mortalities. Intentional overdosing of Meropenem for Injection and Sodium Chloride 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 post-marketing 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. Symptomatic treatments should be considered.

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 23 mcg/mL (range 14-26) for the 500 mg dose and 49 mcg/mL (range 39-58) for the 1 gram dose. A 5-minute intravenous bolus injection of meropenem in healthy volunteers results in mean peak plasma concentrations of approximately 45 mcg/mL (range 18-65) for the 500 mg dose and 112 mcg/mL (range 83-140) 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 500 mg administered every 8 hours or 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 to 1.5 hours) after the start of infusion, except where indicated in the tissues and fluids listed in table 3 below. Table 3: Meropenem Concentrations in Selected Tissues (Highest Concentrations Reported) Tissue Intravenous Dose (gram) Number of Samples Mean [mcg/mL or mcg/(g)] at 1 hour unless otherwise noted Range [mcg/mL or mcg/(g)] Endometrium 0.5 7 4.2 1.7–10.2 Myometrium 0.5 15 3.8 0.4–8.1 Ovary 0.5 8 2.8 0.8–4.8 Cervix 0.5 2 7 5.4–8.5 Fallopian tube 0.5 9 1.7 0.3-3.4 Skin 0.5 22 3.3 0.5–12.6 Interstitial fluid obtained from blister fluid 0.5 9 5.5 3.2-8.6 Skin 1 10 5.3 1.3–16.7 Interstitial fluid 1 5 26.3 20.9–37.4 Colon 1 2 2.6 2.5–2.7 Bile 1 7 14.6 (3 hours) 4.0–25.7 Gall bladder 1 1 —

3.9Peritoneal fluid 1 9 30.2 7.4–54.6 Lung 1 2 4.8 (2 hours) 1.4–8.2 Bronchial mucosa 1 7 4.5 1.3–11.1 Muscle 1 2 6.1 (2 hours) 5.3–6.9 Fascia 1 9 8.8 1.5–20 Heart valves 1 7 9.7 6.4–12.1 Myocardium 1 10 15.5 5.2–25.5 CSF (inflamed) 20 mg/kg in pediatric patients of age 5 months to 8 years 8 1.1 (2 hours) 0.2-2.8 40 mg/kg in pediatric patients of age 1 month to 15 years 5 3.3 (3 hours) 0.9-6.5 CSF (uninflamed) 1 4 0.2 (2 hours) 0.1–0.3 Elimination In subjects with normal renal function, the elimination half-life of meropenem is approximately 1 hour.

Metabolism There is one metabolite of meropenem that is microbiologically inactive. Excretion Meropenem is primarily excreted unchanged by the kidneys. Approximately 70% (50 – 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 Renal Impairment Pharmacokinetic studies with meropenem for injection in patients with renal impairment have shown that the plasma clearance of meropenem correlates with creatinine clearance. Dosage adjustments are necessary in subjects with renal impairment (creatinine clearance 50 mL/min or less) [see Dosage and Administration (2.2 ) and Use In Specific Populations (8.6) ].

Meropenem is hemodialyzable. However, there is no information on the usefulness of hemodialysis to treat overdosage [see Overdosage (10) ]. Patients with Hepatic Impairment A pharmacokinetic… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 13 words ▾

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

📦 How Supplied / Storage and Handling 129 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Meropenem for Injection USP and Sodium Chloride Injection USP in the DUPLEX® Container is a flexible dual chamber single-dose container supplied in two concentrations. The diluent chamber contains approximately 50 mL of 0.9% Sodium Chloride Injection USP. After reconstitution, the delivered doses are equivalent to 500 Anhydrous basis. mg and 1 gram meropenem.

Meropenem for Injection USP and Sodium Chloride Injection USP is supplied sterile and nonpyrogenic in the DUPLEX ® Container packaged 24 units per case. NDC REF Dose Volume 0264-3183-11 3183-11 500 mg 50 mL 0264-3185-11 3185-11 1 gram 50 mL Store the unactivated unit at 20°C–25°C (68°F–77°F). Excursion permitted to 15°C-30°C. [See USP Controlled Room Temperature.] Protect from freezing.

Use only if prepared solution is clear and free from particulate matter.

📋 Description ~1 min read ▾

11 DESCRIPTION Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial drug for intravenous administration. Meropenem is (4 R ,5 S ,6 S )-3- [[(3 S ,5 S )-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1 R )-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 for injection is a white to pale yellow crystalline powder containing meropenem trihydrate and sodium carbonate. The constituted solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3.

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 USP and Sodium Chloride Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of meropenem (drug chamber) and 50 mL of sodium chloride (diluent) in the DUPLEX ® sterile container. When reconstituted as instructed, each 1 gram Meropenem for injection in the DUPLEX ® Container will deliver 1 gram of meropenem and a total sodium content of 290.2 mg (12.6 mEq).

Each 500 mg Meropenem for injection in the DUPLEX ® Container will deliver 500 mg of meropenem and a total sodium content of 245.1 mg (10.7 mEq) [see Dosage and Administration (2.4) ]. The osmolality of the reconstituted solution of Meropenem for Injection USP and Sodium Chloride Injection USP is approximately 356 mOsmol/kg for the 500 mg dose and approximately 417 mOsmol/kg for the 1 gram dose. The DUPLEX ® Container is a flexible dual chamber container.

After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP). structural formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Patients should be counseled that antibacterial drugs including Meropenem for Injection and Sodium Chloride Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Meropenem for Injection and Sodium Chloride 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 and Sodium Chloride Injection or other antibacterial drugs in the future. 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) ]. 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 and Sodium Chloride Injection.

If treatment with Meropenem for Injection and Sodium Chloride Injection is necessary and continued, alternative or supplemental anti-convulsant medication to prevent and/or treat seizures may be needed [see Warnings and Precautions (5.5) ]. Patients receiving Meropenem for Injection and Sodium Chloride 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 and Sodium Chloride Injection is well tolerated, patients should not operate machinery or motorized vehicles [see Warnings and Precautions (5.10) ].

Meropenem for Injection and Sodium Chloride Injection contains a high sodium load. Instruct patients to inform or report symptoms of difficulty breathing, swelling, or increased weight [see Warnings and Precautions (5.11) ].

🍼 Nursing Mothers 85 words ▾

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 breastfed –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 Sodium Chloride Injection in the DUPLEX® Container and any potential adverse effects on the breastfed-child from Meropenem for Injection and Sodium Chloride Injection in the DUPLEX® Container or from the underlying maternal conditions.

🧬 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 23 mcg/mL (range 14-26) for the 500 mg dose and 49 mcg/mL (range 39-58) for the 1 gram dose. A 5-minute intravenous bolus injection of meropenem in healthy volunteers results in mean peak plasma concentrations of approximately 45 mcg/mL (range 18-65) for the 500 mg dose and 112 mcg/mL (range 83-140) 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 500 mg administered every 8 hours or 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 to 1.5 hours) after the start of infusion, except where indicated in the tissues and fluids listed in table 3 below. Table 3: Meropenem Concentrations in Selected Tissues (Highest Concentrations Reported) Tissue Intravenous Dose (gram) Number of Samples Mean [mcg/mL or mcg/(g)] at 1 hour unless otherwise noted Range [mcg/mL or mcg/(g)] Endometrium 0.5 7 4.2 1.7–10.2 Myometrium 0.5 15 3.8 0.4–8.1 Ovary 0.5 8 2.8 0.8–4.8 Cervix 0.5 2 7 5.4–8.5 Fallopian tube 0.5 9 1.7 0.3-3.4 Skin 0.5 22 3.3 0.5–12.6 Interstitial fluid obtained from blister fluid 0.5 9 5.5 3.2-8.6 Skin 1 10 5.3 1.3–16.7 Interstitial fluid 1 5 26.3 20.9–37.4 Colon 1 2 2.6 2.5–2.7 Bile 1 7 14.6 (3 hours) 4.0–25.7 Gall bladder 1 1 —

3.9Peritoneal fluid 1 9 30.2 7.4–54.6 Lung 1 2 4.8 (2 hours) 1.4–8.2 Bronchial mucosa 1 7 4.5 1.3–11.1 Muscle 1 2 6.1 (2 hours) 5.3–6.9 Fascia 1 9 8.8 1.5–20 Heart valves 1 7 9.7 6.4–12.1 Myocardium 1 10 15.5 5.2–25.5 CSF (inflamed) 20 mg/kg in pediatric patients of age 5 months to 8 years 8 1.1 (2 hours) 0.2-2.8 40 mg/kg in pediatric patients of age 1 month to 15 years 5 3.3 (3 hours) 0.9-6.5 CSF (uninflamed) 1 4 0.2 (2 hours) 0.1–0.3 Elimination In subjects with normal renal function, the elimination half-life of meropenem is approximately 1 hour.

Metabolism There is one metabolite of meropenem that is microbiologically inactive. Excretion Meropenem is primarily excreted unchanged by the kidneys. Approximately 70% (50 – 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 Renal Impairment Pharmacokinetic studies with meropenem for injection in patients with renal impairment have shown that the plasma clearance of meropenem correlates with creatinine clearance. Dosage adjustments are necessary in subjects with renal impairment (creatinine clearance 50 mL/min or less) [see Dosage and Administration (2.2 ) and Use In Specific Populations (8.6) ].

Meropenem is hemodialyzable. However, there is no information on the usefulness of hemodialysis to treat overdosage [see Overdosage (10) ]. 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.

Geriatric Patients A pharmacokinetic study with meropenem for injection in elderly patients with renal impairment showed a reduction in plasma clearance of meropenem that correlates with age-associated reduction in creatinine clearance. Pediatric Patients The p… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Complicated Skin and Skin Structure Infections Adult patients with complicated skin and skin structure infections including complicated cellulitis, complex abscesses, perirectal abscesses, and skin infections requiring intravenous antimicrobials, hospitalization, and surgical intervention were enrolled in a randomized, multi-center, international, double-blind trial. The study evaluated meropenem at doses of 500 mg administered intravenously every 8 hours and imipenem-cilastatin at doses of 500 mg administered intravenously every 8 hours.

The study compared the clinical response between treatment groups in the clinically evaluable population at the follow-up visit (test-of-cure). The trial was conducted in the United States, South Africa, Canada, and Brazil. At enrollment, approximately 37% of the patients had underlying diabetes, 12% had underlying peripheral vascular disease and 67% had a surgical intervention.

The study included 510 patients randomized to meropenem and 527 patients randomized to imipenem-cilastatin. Two hundred and sixty one (261) patients randomized to meropenem and 287 patients randomized to imipenem-cilastatin were clinically evaluable. The success rates in the clinically evaluable patients at the follow-up visit were 86% (225/261) in the meropenem arm and 83% (238/287) in imipenem-cilastatin arm.

The success rates for clinically evaluable population are provided in Table 5. Table 5: Success Rates at Test-of-Cure Visit for Clinically Evaluable Population with Complicated Skin and Skin Structure Infections Population Meropenem for Injection n n=number of patients with satisfactory response. /N N=number of patients in the clinically evaluable population or respective subgroup within treatment groups. (%) Imipenem-cilastatin n /N (%) Total 225/261 (86) 238/287 (83) Diabetes mellitus 83/97 (86) 76/105 (72) No diabetes mellitus 142/164 (87) 162/182 (89) Less than 65 years of age 190/218 (87) 205/241 (85) 65 years of age and older 35/43 (81) 33/46 (72) Men 130/148 (88) 137/172 (80) Women 95/113 (84) 101/115 (88) The clinical efficacy rates by pathogen are provided in Table 6.

The values represent the number of patients clinically cured/number of clinically evaluable patients at the post-treatment follow-up visit, with the percent cure in parentheses (Fully Evaluable analysis set). Table 6: Clinical Efficacy Rates by Pathogen for Clinically Evaluable Population MICROORGANISMS Patients may have more than one pretreatment pathogen. Meropenem for Injection n n=number of patients with satisfactory response. /N N=number of patients in the clinically evaluable population or subgroup within treatment groups.

(%) %= Percent of satisfactory clinical response at follow-up evaluation. Imipenem-cilastatin n /N (%) Gram-positive aerobes Staphylococcus aureus, methicillin susceptible 82/88 (93) 84/100 (84) Streptococcus pyogenes (Group A) 26/29 (90) 28/32 (88) Streptococcus agalactiae (Group B) 12/17 (71) 16/19 (84) Enterococcus faecalis 9/12 (75) 14/20 (70) Viridans group streptococci 11/12 (92) 5/6 (83) Gram-negative aerobes Escherichia coli 12/15 (80) 15/21 (71) Pseudomonas aeruginosa 11/15 (73) 13/15 (87) Proteus mirabilis 11/13 (85) 6/7 (86) Anaerobes Bacteroides fragilis 10/11 (91) 9/10 (90) Peptostreptococcus spp.

10/13 (77) 14/16 (88) The proportion of patients who discontinued study treatment due to an adverse event was similar for both treatment groups (meropenem, 2.5% and imipenem-cilastatin, 2.7%).

14.2Complicated Intra-Abdominal Infections One controlled clinical study of complicated intra-abdominal infection was performed in the United States where meropenem was compared with clindamycin/tobramycin. Three controlled clinical studies of complicated intra-abdominal infections were performed in Europe; meropenem was compared with imipenem (two trials) and cefotaxime/metronidazole (one trial). Using strict evaluability criteria and microbiologic eradication and clinical cures at follow-up… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 99 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: Reproductive studies performed with meropenem in rats at doses up to 1000 mg/kg/day, (approximately 1.8 times the human exposure at a dose of 1 gram every 8 hours based on AUC) showed no evidence of fertility impairment.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 96 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: Reproductive studies performed with meropenem in rats at doses up to 1000 mg/kg/day, (approximately 1.8 times the human exposure at a dose of 1 gram every 8 hours based on AUC) showed no evidence of fertility impairment.

📚 References 36 words ▾

15 REFERENCES Cockcroft DW, MH Gault, 1976, Prediction of creatinine clearance from serum creatinine, Nephron, 16:31-41. 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 11 words ▾

RECENT MAJOR CHANGES Warnings and Precautions, Rhabdomyolysis ( 5.3 ) 12/2024

📄 Package Label / Principal Display Panel ~3 min read ▾

PRINCIPAL DISPLAY PANEL - 500 mg Meropenem for Injection USP and Sodium Chloride Injection USP 500 mg* 50 mL NDC 0264-3183-11 DUPLEX ® CONTAINER USE ONLY AFTER MIXING CONTENTS OF BOTH CHAMBERS. FOR INTRAVENOUS INFUSION ONLY SINGLE-DOSE * Contains sterile meropenem trihydrate USP equivalent to 500 mg of meropenem activity and sodium carbonate as a buffering agent. Hyperosmotic Sterile/Nonpyrogenic After reconstitution each 50 mL single-dose DUPLEX® unit contains Meropenem for Injection USP (equivalent to 500 mg meropenem) and a total sodium content of 245.1 mg (10.7 mEq).

Approximate osmolality: 356 mOsmol/kg Prior to Reconstitution: Store at 20°C-25°C (68°F-77°F). [See USP Controlled Room Temperature.] Use only if container and seals are intact. Do not peel foil strip until ready for use. After foil strip removal, product must be used within 7 days, but not beyond the labeled expiration date.

Protect from light after removal of foil strip. Reconstitution: Hold container with set port in a downward direction and fold the diluent chamber just below the solution meniscus. To activate seal, squeeze folded diluent chamber until seal between diluent and drug chamber opens, releasing diluent into drug chamber.

Agitate the reconstituted solution until the drug powder is completely dissolved. Fold the container a second time and squeeze until seal between drug chamber and set port opens. After Reconstitution: Use only if prepared solution is clear and free from particulate matter.

Use within 1 hour if stored at room temperature or within 15 hours if stored under refrigeration. Do not use in a series connection. Do not introduce additives into this container.

Prior to administration check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be impaired. Do not freeze.

Discard unused portion. Not made with natural rubber latex, PVC or DEHP. REF 3183-11 Rx only E113USMERO502 Manufactured for: B.

Braun Medical Inc. Prepared in Italy. API from Italy and Austria.

Y37-002-563 LD-440-4 EXP LOT 3183-11 Container Label

PRINCIPAL DISPLAY PANEL - 1 g Meropenem for Injection USP and Sodium Chloride Injection USP 1 g* 50 mL NDC 0264-3185-11 DUPLEX ® CONTAINER USE ONLY AFTER MIXING CONTENTS OF BOTH CHAMBERS. FOR INTRAVENOUS INFUSION ONLY SINGLE-DOSE * Contains sterile meropenem trihydrate USP equivalent to 1 g of meropenem activity and sodium carbonate as a buffering agent. Hyperosmotic Sterile/Nonpyrogenic After reconstitution each 50 mL single-dose DUPLEX® unit contains Meropenem for Injection USP (equivalent to 1 g meropenem) and a total sodium content of 290.2 mg (12.6 mEq).

Approximate osmolality: 417 mOsmol/kg Prior to Reconstitution: Store at 20°C-25°C (68°F-77°F). [See USP Controlled Room Temperature.] Use only if container and seals are intact. Do not peel foil strip until ready for use. After foil strip removal, product must be used within 7 days, but not beyond the labeled expiration date.

Protect from light after removal of foil strip. Reconstitution: Hold container with set port in a downward direction and fold the diluent chamber just below the solution meniscus. To activate seal, squeeze folded diluent chamber until seal between diluent and drug chamber opens, releasing diluent into drug chamber.

Agitate the reconstituted solution until the drug powder is completely dissolved. Fold the container a second time and squeeze until seal between drug chamber and set port opens. After Reconstitution: Use only if prepared solution is clear and free from particulate matter.

Use within 1 hour if stored at room temperature or within 15 hours if stored under refrigeration. Do not use in a series connection. Do not introduce additives into this container.

Prior to administration check for minute leaks by squeezing container firmly. If leaks are found, discard container and solution as sterility may be impaired. Do not freeze.

Discard unused portion. Not made with natural rubber latex,… [Excerpted — this section continues on DailyMed.]

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
302
Units reimbursed last 4 qtrs
92.5K
Gross reimbursed last 4 qtrs
$55.1K
Avg / prescription
$182.34
Avg / unit
$0.5952
Latest quarter Q1 2026
53Rx
Fee-for-service vs managed care ⓘ
29% FFS 71% MCO
Fee-for-service · 88 Rx Managed care · 214 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: no data reported MI New York: 1,011 units · 5.2 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: 48,300 units · 385 per 100k residents IL Indiana: no data reported IN Ohio: 12,150 units · 103 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported 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: no data reported MD Connecticut: no data reported CT Rhode Island: 249 units · 22.7 per 100k residents RI Arizona: no data reported AZ New Mexico: no data reported 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: 8,051 units · 561 per 100k residents HI Texas: no data reported TX Florida: 22,750 units · 101 per 100k residents FL
Units reimbursed · per 100k residents
5.2561
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 Hawaii 561 /100k
2 Illinois 385 /100k
3 Ohio 103 /100k
4 Florida 101 /100k
5 Rhode Island 22.7 /100k
6 New York 5.2 /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.

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) ✓ 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 B. Braun Medical Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
B. Braun Medical Inc. 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 J2184 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.
← 00264-3155-11 · B. 00264-3185-11 · B. →
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.