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Zaynich zidebactam dihydrate and cefepime hydrochloride 1 g; 2 g Injection, Powder, For Solution, 1 vial — NDC 87706-0866-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Zaynich zidebactam dihydrate and cefepime hydrochloride 1 g; 2 g Injection, Powder, For Solution, 1 vial — NDC 87706-866-01 (Billing 87706-0866-01)

by Wockhardt Suisse USA LLC · 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

This is a package of 1 vial of Zaynich zidebactam dihydrate and cefepime hydrochloride 1 g; 2 g Injection, Powder, For Solution from Wockhardt Suisse USA LLC, marketed since May 2026 and currently FDA-listed. It is this product's only package size.

NDC 87706-0866-01
🏷️ FDA NDC (as labeled) 87706-866-01 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 Aug 27, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 87706-866-01
Product NDC 87706-866
11-digit billing NDC 87706086601
RxCUI 2744819, 2744824
UNII TE54T8WC4T, I8X1O0607P
UPC 0387706866001
Application # NDA220787
SPL Set ID c84e652e-5e76-4568-8812-bd5fa34803b6
Established class (EPC) Cephalosporin Antibacterial
Chemical class Cephalosporins
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-29
Route INTRAVENOUS
Dosage form INJECTION, POWDER, FOR SOLUTION
Substance ZIDEBACTAM DIHYDRATE; CEFEPIME HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 2744819
Why two NDCs? The FDA registers this code as 87706-866-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 87706-0866-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Cephalosporin Antibacterial class.

Pharmacologic class Cephalosporin Antibacterial
Drug family (ATC) Fourth-generation cephalosporins
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Cefepime and zidebactam injection is used to treat urinary tract infections (UTI) caused by specific bacteria. Cefepime is in a class of antibiotics called cephalosporins. It works by killing bacteria. Zidebactam is in a class called beta-lactamase inhibitors. It works by preventing bacteria from destroying cefepime. Antibiotics such as cefepime and zidebactam injection will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

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

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
87706-0866-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2026-05-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zaynich 1 g/1; 2 gthis 87706-0866-01 Wockhardt 1 vial — — 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

🏛️
2026
First FDA approval
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🛡️
2036
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2036. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 29, 2026 RLD RS ⏳ ~9.7 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9132133 — method of use (U-4558)
US 9827235 — method of use (U-4558)
US 9834557 — drug substance
US 9657021 — drug substance
US 8853197 — drug substance
US 9381200 — drug product
US 8822450 — drug substance
Exclusivity NCE
Exclusivity GAIN
2026 2028 2030 2032 2034 2036
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (7)
PatentTypeUse codeExpires
US 9132133 ↗ Method of use U-4558 Aug 24, 2032
US 9827235 ↗ Method of use U-4558 Aug 24, 2032
US 9834557 ↗ Drug substance — Oct 12, 2033
US 9657021 ↗ Drug substance — Oct 12, 2033
US 8853197 ↗ Drug substance — Aug 24, 2032
US 9381200 ↗ Drug product — Aug 24, 2032
US 8822450 ↗ Drug substance — Aug 24, 2032
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)May 29, 2031
GAINQualified Infectious Disease Product (+5-year)May 29, 2036
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until May 2036 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

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

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

  • UNII 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.

1 inactive ingredient listed in the exact product block matched to this NDC.

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerWockhardt Suisse USA LLC
Application holderWOCKHARDT BIO AG
FDA applicationNDA220787 (NDA)
Labeler code87706
First marketedMay 2026
Product typeHuman Prescription Drug
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 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 218 words ▾

1 INDICATIONS AND USAGE ZAYNICH is a combination of cefepime, a cephalosporin antibacterial, and zidebactam, a beta-lactamase inhibitor and non-beta-lactam antibacterial indicated for the treatment of adult patients with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible microorganisms. ( 1.1 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZAYNICH and other antibacterial drugs, ZAYNICH should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

( 1.2 )

1.1Complicated Urinary Tract Infections, including Pyelonephritis ZAYNICH is indicated for the treatment of adult patients with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae complex, and Pseudomonas aeruginosa .

1.2Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZAYNICH and other antibacterial drugs, ZAYNICH should be used only 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 Recommended dosage is ZAYNICH 3 grams (2 grams cefepime and 1 gram zidebactam) every 8 hours by intravenous infusion over 1 hour for 7 to 10 days in adult patients with an estimated glomerular filtration rate (eGFR) greater than or equal to 60 mL/min. ( 2.1 ) Dosage adjustment is recommended in adult patients with renal impairment who have an eGFR less than 60 mL/min. ( 2.2 ) Administer each intravenous infusion over 1 hour for patients with renal impairment.

( 2.2 ) Recommended Dosage of ZAYNICH in Adult Patients with Renal Impairment ( 2.2 ) eGFR As calculated using 4-variable Modification of Diet in Renal Disease (MDRD) formula. (mL/min) Dose The total duration of treatment is for 7 to 10 days. Dosing Interval 60 to 89 ZAYNICH 3 grams Provides 2 grams cefepime and 1 gram zidebactam.

Every 8 hours 30 to 59 ZAYNICH 1.5 grams Provides 1 gram cefepime and 0.5 grams zidebactam. Every 8 hours 15 to 29 ZAYNICH 1.5 grams Every 12 hours 8 to 14 (with or without intermittent hemodialysis (IHD)) On hemodialysis days, recommended dose should be administered after a hemodialysis session. On days, when hemodialysis is not performed, administer recommended dose 24 hours after the previous dose.

ZAYNICH 1.5 grams Every 24 hours See Full Prescribing Information for instructions for reconstituting supplied dry powder and subsequent required dilution. ( 2.3 ) See Full Prescribing Information for drug compatibilities. ( 2.4 )

2.1Recommended Dosage The recommended dosage of ZAYNICH is 3 grams (2 grams cefepime and 1 gram zidebactam) administered every 8 hours by intravenous (IV) infusion over 1 hour in adult patients with an eGFR greater than or equal to 60 mL/min. The duration of treatment is 7 days to 10 days.

2.2Recommended Dosage in Adult Patients with Renal Impairment Table 1 shows the recommended intravenous dosage of ZAYNICH for patients with varying degrees of renal function. Dosage adjustment of ZAYNICH is recommended in adult patients with renal impairment who have an eGFR of less than 60 mL/min, including patients receiving intermittent hemodialysis (IHD) [ see Use in Specific Populations ( 8.6 ) ]. The duration of treatment is 7 days to 10 days.

Administer each intravenous infusion over 1 hour. Table 1: Recommended Dosage of ZAYNICH in Adult Patients with Renal Impairment eGFR As calculated using the 4-variable Modification of Diet in Renal Disease (MDRD) formula. (mL/min) Dose The total duration of treatment is for 7 to 10 days.

Dosing Interval 60 to 89 ZAYNICH 3 grams Provides 2 grams cefepime and 1 gram zidebactam. Every 8 hours 30 to 59 ZAYNICH 1.5 grams Provides 1 gram cefepime and 0.5 grams zidebactam. Every 8 hours 15 to 29 ZAYNICH 1.5 grams Every 12 hours 8 to 14 (with or without IHD) On hemodialysis days, recommended dose should be administered after a hemodialysis session.

On days, when hemodialysis is not performed, administer 24 hours after the previous dose. ZAYNICH 1.5 grams Every 24 hours

2.3Preparation and Administration Instructions for ZAYNICH Preparation ZAYNICH is supplied as a sterile dry powder in a single-dose vial that must be reconstituted and further diluted prior to intravenous infusion as outlined below. ZAYNICH does not contain preservatives. Aseptic techniques must be used for reconstitution and dilution.

Prepare the required dose for intravenous infusion using the steps described below: 1. Reconstitute the powder in the ZAYNICH vial with 10 mL of 0.9% Sodium Chloride Injection, or 5% Dextrose Injection, or Lactated Ringer's solution from a 100 mL infusion bag or with 10 mL of sterile Water for Injection. 2.

Mix gently to dissolve the content. The reconstituted ZAYNICH solution will have a resultant concentration of approximately 240 mg/mL. The final volume is approximately 13 mL.

3. The reconstituted ZAYNICH solution is not for direct injection and must be further diluted, prior to administration as described in Step 4 below. 4.

The reconstituted solution should be used i… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 67 words ▾

3 DOSAGE FORMS AND STRENGTHS ZAYNICH 3 grams (cefepime and zidebactam) for injection is supplied as a sterile white to pale yellow powder for reconstitution in a single-dose vial, containing 2 grams cefepime and 1 gram zidebactam. ZAYNICH 3 grams (cefepime and zidebactam) for injection is supplied as a sterile powder for reconstitution in single-dose vials, containing 2 grams cefepime and 1 gram zidebactam. ( 3 )

⛔ Contraindications 64 words ▾

4 CONTRAINDICATIONS ZAYNICH is contraindicated in patients with a known history of serious hypersensitivity to the components of ZAYNICH (cefepime and zidebactam) or other beta-lactam antibacterial drugs [ see Warnings and Precautions ( 5.1 ) ]. ZAYNICH is contraindicated in patients with a known history of serious hypersensitivity to the components of ZAYNICH (cefepime and zidebactam) or other beta-lactam antibacterial drugs. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions : Serious hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with ZAYNICH. If an allergic reaction to ZAYNICH occurs, discontinue the drug and institute appropriate supportive measures. ( 5.1 ) Neurotoxicity: Neurotoxicity has been reported during treatment with cefepime, a component of ZAYNICH.

Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment of cefepime. If neurotoxicity occurs, discontinue ZAYNICH and institute appropriate supportive measures. ( 5.2) Clostridioides difficile Infection: Clostridioides difficile infection has been reported with nearly all systemic antibacterial agents, including ZAYNICH.

Evaluate if diarrhea occurs. ( 5.3 )

5.1Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with ZAYNICH. Serious and occasionally fatal hypersensitivity reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs [ see Contraindications ( 4 ) and Adverse Reactions ( 6.1 , 6.2 ) ]. Before therapy with ZAYNICH is instituted, carefully inquire about previous hypersensitivity reactions to cefepime, cephalosporins, penicillins, or other beta-lactams because cross-hypersensitivity among beta-lactam antibacterial drugs has been reported.

If an allergic reaction to ZAYNICH occurs, discontinue the drug and institute appropriate supportive measures.

5.2Neurotoxicity Neurotoxicity has been reported during treatment with cefepime, a component of ZAYNICH, including life threatening or fatal occurrences of the following: encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), aphasia, myoclonus, seizures, and nonconvulsive status epilepticus [see Adverse Reactions ( 6.2 )] . Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment. However, some cases of neurotoxicity occurred in patients receiving a dosage adjustment appropriate for their degree of renal impairment.

In the majority of cases, symptoms of neurotoxicity were reversible and resolved after discontinuation of cefepime and/or after hemodialysis. If neurotoxicity associated with ZAYNICH therapy occurs, discontinue ZAYNICH and institute appropriate supportive measures.

5.3Clostridioides difficile Infection Clostridioides difficile (C. difficile) infection (CDI) has been reported with the use of nearly all antibacterial agents including ZAYNICH and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDI.

Hypertoxin-producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDI must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDI has been reported to occur over two months after the administration of antibacterial agents.

If CDI is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

5.4Positive Direct Coombs’ Tests Positive direct Coombs' tests with or without hemolysis have been reported during treatment with cefepime, a component of ZAYNICH. In patients who develop hemolytic anemia, discontinue the drug and institute appropriate therapy. Positive Coombs' test may be observed in newborns whose mothers have received cephalosporin antibacterial drugs before parturition.

5.5Prolonged Prothr… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [ see Warnings and Precautions ( 5.1 ) ] Neurotoxicity [ see Warnings and Precautions ( 5.2 ) ] Clostridiodes difficile Infection [ see Warnings and Precautions ( 5.3 ) ] The most common adverse reactions occurring in ≥ 2% of patients treated with ZAYNICH were diarrhea, headache, hypertension, and hypokalemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Wockhardt Suisse USA LLC at 1-844-367-6548 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. ZAYNICH was evaluated in a phase 3 study in patients with cUTI, including pyelonephritis (also referred to as Trial 1), which included 352 patients treated with ZAYNICH 3 grams (2 grams cefepime and 1 gram zidebactam) every 8 hours infused over 1 hour, and 177 patients treated with the comparator, meropenem, 1 gram every 8 hours, infused over 30 minutes.

Patients received treatment for 7 to 10 days. The median duration of therapy was 8 days in both treatment groups in the safety analysis set. The mean age of patients treated with ZAYNICH was 65 years and 61% of patients were 65 years of age or older.

Patients were predominantly male (56%) and White (88%). Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation Treatment was discontinued due to adverse reactions in 1.4% (5/352) of patients receiving ZAYNICH and in 1.1% (2/177) of patients receiving meropenem. The adverse reactions resulting in discontinuation of ZAYNICH were anaphylactic reaction, C. difficile colitis, hyperbilirubinemia, drug hypersensitivity, and enterococcal urinary tract infection, each 0.3% (1/352).

No deaths were reported. Common Adverse Reactions The most frequently reported adverse reactions (2% or greater) in patients receiving ZAYNICH were diarrhea, hypertension, headache, and hypokalemia. Table 3 lists selected adverse reactions occurring in 2% or greater of patients receiving ZAYNICH in Trial 1.

Table 3: Selected Adverse Reactions Occurring in 2% or Greater of cUTI Patients Receiving ZAYNICH in Trial 1 Trial 1 was not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the ZAYNICH and the meropenem treatment groups. Adverse Reactions ZAYNICH (N=352) n (%) Meropenem (N=177) n (%) Diarrhea 15 (4) 7 (4) Hypertension Hypertension includes blood pressure inadequately controlled and hypertension. 12 (3) 3 (2) Headache 11 (3) 9 (5) Hypokalemia 10 (3) 2 (1) Other Adverse Reactions Associated with ZAYNICH The following selected adverse reactions were reported in ZAYNICH-treated patients at a rate of less than 2% in Trial 1: Blood and lymphatic system disorders: anemia, neutropenia, thrombocytopenia Gastrointestinal disorders: abdominal pain, constipation, nausea, vomiting General disorders and administration site conditions : pyrexia, infusion site reaction including injection site erythema, vascular access site hematoma Hepatobiliary disorders: hyperbilirubinemia Infections and infestations: C. difficile colitis, candida infection including oral candidiasis, genital candidiasis, candiduria Immune system disorders: allergic reaction including anaphylactic reaction, drug hypersensitivity, rash, skin burning sensation, flushing Laboratory investigations: transaminases increased including alanine aminotransferase increased, aspartate aminotransferase increased Metabolism and nutrition disorders : hyperglycemia Nervous system disorders: dizziness Psychiatric disorders: anxiety, delirium Respiratory disorders : shortness of breath Renal and urinary disorders : acute kidney injury including blood creatinine increased, blood urea n… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 94 words ▾

7 DRUG INTERACTIONS

7.1Aminoglycosides Monitor renal function if aminoglycosides are to be administered with ZAYNICH because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs.

7.2Diuretics Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide. Monitor renal function when ZAYNICH is concomitantly administered with potent diuretics.

7.3Drug/Laboratory Test Interactions The administration of ZAYNICH may result in a false-positive reaction for glucose in the urine with certain methods. It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Geriatric Use : Serious neurologic adverse reactions have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, a component of ZAYNICH. Care should be taken in dose selection for elderly patients and renal function should be monitored as appropriate. ( 8.5 )

8.1Pregnancy Risk Summary There are no data for the use of ZAYNICH, or zidebactam, a component of ZAYNICH, during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Available data from published observational studies and case reports over several decades with cephalosporin use, including cefepime, in pregnant women have not established the drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes. Cefepime Cefepime was not associated with adverse developmental outcomes in rats, mice, or rabbits when administered parenterally during organogenesis.

The doses used in these studies were 1.6 (rats), approximately equal to (mice), and 0.3 times (rabbits) the recommended human dose of cefepime in ZAYNICH (see Data). Zidebactam Intravenous administration of zidebactam to pregnant rats during organogenesis showed no evidence of maternal or embryo-fetal toxicity at a dose of 800 mg/kg/day, approximately 5 times the recommended human dose (RHD; 1 gram zidebactam administered every 8 hours) based on plasma area under the concentration-time curve (AUC) comparison. In pregnant rabbits, intravenous administration of zidebactam during organogenesis was associated with increased late fetal resorptions and total fetal loss in two litters at a dose of 600 mg/kg/day (approximately 5 times the RHD) and distended bladder, a fetal anomaly, at zidebactam doses greater than or equal to 300 mg/kg/day (approximately 3 times the RHD).

In a pre-postnatal study, zidebactam administered intravenously to pregnant rats during organogenesis and through the lactation period was not associated with maternal toxicity or adverse effects in first- and second-generation offspring at a maternal dose of 800 mg/kg/day, approximately 5 times the RHD (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 Human Data Cefepime While available studies cannot definitively establish the absence of risk, published data from case-control studies and case reports over several decades have not identified an association with cephalosporin use, including cefepime, during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Available studies have methodological limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal Data Cefepime Cefepime was not embryocidal and did not cause fetal malformation when administered parenterally during the period of organogenesis to rats at doses up to 1000 mg/kg/day, to mice at doses up to 1200 mg/kg/day, or to rabbits at doses up to 100 mg/kg/day. These doses are 1.6 times (rats), approximately equal to (mice), and 0.3 times (rabbits) the recommended clinical dose of cefepime in ZAYNICH based on body surface area.

Zidebactam In an embryo-fetal development study in pregnant rats, zidebactam in doses of 200, 400, and 800 mg/kg/day administered intravenously in divided doses twice per day during the period of organogenesis from Gestation Day (GD) 6 to GD 17 was not associated with maternal or embryo-fetal toxicity at any dose. The plasma zidebactam exposure for the high dose of 800 mg/kg/day was approximately 5 times the RHD based on plasma AUC comparison. Zidebactam administered to pregnant rabbit… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary There are no data for the use of ZAYNICH, or zidebactam, a component of ZAYNICH, during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Available data from published observational studies and case reports over several decades with cephalosporin use, including cefepime, in pregnant women have not established the drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes. Cefepime Cefepime was not associated with adverse developmental outcomes in rats, mice, or rabbits when administered parenterally during organogenesis.

The doses used in these studies were 1.6 (rats), approximately equal to (mice), and 0.3 times (rabbits) the recommended human dose of cefepime in ZAYNICH (see Data). Zidebactam Intravenous administration of zidebactam to pregnant rats during organogenesis showed no evidence of maternal or embryo-fetal toxicity at a dose of 800 mg/kg/day, approximately 5 times the recommended human dose (RHD; 1 gram zidebactam administered every 8 hours) based on plasma area under the concentration-time curve (AUC) comparison. In pregnant rabbits, intravenous administration of zidebactam during organogenesis was associated with increased late fetal resorptions and total fetal loss in two litters at a dose of 600 mg/kg/day (approximately 5 times the RHD) and distended bladder, a fetal anomaly, at zidebactam doses greater than or equal to 300 mg/kg/day (approximately 3 times the RHD).

In a pre-postnatal study, zidebactam administered intravenously to pregnant rats during organogenesis and through the lactation period was not associated with maternal toxicity or adverse effects in first- and second-generation offspring at a maternal dose of 800 mg/kg/day, approximately 5 times the RHD (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 Human Data Cefepime While available studies cannot definitively establish the absence of risk, published data from case-control studies and case reports over several decades have not identified an association with cephalosporin use, including cefepime, during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Available studies have methodological limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal Data Cefepime Cefepime was not embryocidal and did not cause fetal malformation when administered parenterally during the period of organogenesis to rats at doses up to 1000 mg/kg/day, to mice at doses up to 1200 mg/kg/day, or to rabbits at doses up to 100 mg/kg/day. These doses are 1.6 times (rats), approximately equal to (mice), and 0.3 times (rabbits) the recommended clinical dose of cefepime in ZAYNICH based on body surface area.

Zidebactam In an embryo-fetal development study in pregnant rats, zidebactam in doses of 200, 400, and 800 mg/kg/day administered intravenously in divided doses twice per day during the period of organogenesis from Gestation Day (GD) 6 to GD 17 was not associated with maternal or embryo-fetal toxicity at any dose. The plasma zidebactam exposure for the high dose of 800 mg/kg/day was approximately 5 times the RHD based on plasma AUC comparison. Zidebactam administered to pregnant rabbits in doses of 150, 300, and 600 mg/kg/day in divided intravenous doses administered twice per day during the period of organogenesis from GD 6 to GD 18 was associated with significantly increased late fetal resorptions as well as total fetal loss in two litters at a dose of 600 mg/kg/day (approximately 5 times the RHD based o… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of ZAYNICH in pediatric patients have not been established.

🧓 Geriatric Use 211 words ▾

8.5Geriatric Use Of the 352 patients treated with ZAYNICH in the cUTI trial (Trial 1), 213 (61%) patients were 65 years of age and older, while 111 (32%) patients were 75 years of age and older. No overall differences in safety or effectiveness were observed between these patients and younger adult patients, and other reported clinical experience has not identified differences in responses between the elderly and younger adult patients. Serious neurologic adverse reactions have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, a component of ZAYNICH including life threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures [ see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 ) ].

No dosage adjustment based on age is required. ZAYNICH is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored as appropriate.

Dosage adjustment for elderly patients should be based on renal function [ see Dosage and Administration ( 2.2 ) , and Use in Specific Populations ( 8.6 ) ].

🆘 Overdosage 94 words ▾

10 OVERDOSAGE There is no experience with overdose of ZAYNICH. Patients who receive an overdose should be carefully observed and given supportive treatment. Cefepime and zidebactam can be removed by hemodialysis [see Clinical Pharmacology ( 12.3 )] .

No clinical information is available on the use of hemodialysis to treat ZAYNICH overdosage. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, neuromuscular excitability and nonconvulsive status epilepticus [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6.2 ), and Dosage and Administration ( 2.2 )] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Cefepime and zidebactam, components of ZAYNICH, are antibacterial drugs [see Microbiology ( 12.4 )] .

12.2Pharmacodynamics For both cefepime and zidebactam, components of ZAYNICH, the percentage of time that unbound drug exceeds the minimum inhibitory concentration (% f T > MIC) has been shown to best correlate with efficacy in animal and in vitro models of infection. Zidebactam alters the pharmacodynamic activity of cefepime, resulting in a reduction of cefepime's % f T > MIC required for antibacterial activity. Cardiac Electrophysiology At 4 times the maximum recommended zidebactam dose given together with the recommended dose for cefepime, clinically significant QTc interval prolongation was not observed.

12.3Pharmacokinetics Pharmacokinetic (PK) Parameters The PK properties of cefepime and zidebactam are summarized in Table 4 as geometric mean (geometric coefficient of variation, GCV%) in healthy adult subjects. Table 4: Pharmacokinetic Parameters (Geometric mean [GCV%]) of Cefepime and Zidebactam AUC 0-8 = area under the plasma concentration time curve from 0 to 8 h; CL = clearance; C max = maximum concentration; GCV = Geometric coefficient of variation; T 1/2 = terminal half-life; Vz = volume of distribution Pharmacokinetic Parameters Cefepime Zidebactam Exposure C max (mg/L) Pharmacokinetic parameters are presented at steady state (Day 10) in healthy subjects at a dosage of 2 grams cefepime and 1 gram zidebactam every 8 hours (geometric mean (GCV%)).

153 (2.6) 64.3 (6.3) AUC 0-8 (mg•h/L) 362 (6.3) 153 (5.6) Distribution % Bound to human plasma protein 20% 4.0-5.4% Vz (L) 13.7 (5.0) 15.5 (10.1) Proportionality (dose range) 0.25 g – 2.0 g 0.25 g – 3.0 g Accumulation Similar pharmacokinetics following single and multiple dosing Elimination CL (L/h) 5.2 (8.5) 6.2 (5.9) T 1/2 (h) 1.8 (12.9) 1.7 (10.8) Metabolism Approximately 6.8% of the administered dose of cefepime is eliminated in urine as N-oxide and 2.5% as cefepime epimer. Approximately 2.5% of the administered dose of zidebactam is eliminated in urine as zidebactam impurity-1 isomer.

Minimally metabolized Excretion Major route of elimination Renal % Excreted unchanged in urine Arithmetic mean. 85% 88% Specific Populations No clinically significant differences in the PK of cefepime and zidebactam were observed based on age (18 to 90 years), weight (39 to 130 kg), gender (59% male, 41% female), or race (0.02% American Indian or Alaska native, 9% Asian, 14% Black or African American, 75% White). Patients with Renal Impairment In a single-dose trial evaluating the effect of renal impairment on the pharmacokinetics of cefepime and zidebactam, dosage was adjusted for subjects with moderate and severe renal impairment (defined as creatinine clearance, CrCl, less than 60 mL/min).

The dose-normalized systemic exposures of cefepime and zidebactam were higher at all levels of renal impairment compared with healthy subjects with creatinine clearance (CrCl, estimated by Cockcroft-Gault) greater than or equal to 90 mL/min, see Table 5 . Table 5: Dose Normalized Fold AUC 0-infinity Increase in Subjects with Renal Impairment Compared with Subjects with Creatinine Clearance (CrCI) ≥ 90 mL/min AUC 0-infinity = area under the plasma concentration time curve from 0 to time infinity; CrCl = Creatinine clearance; ESRD = end stage renal disease; HD = hemodialysis CrCl (mL/min) Cefepime Zidebactam 60 to 89 1.4 1.3 30 to 59 3.0 3.3 15 to 29 4.2

5.4ESRD on HD 9.9

16.0Patients with Hepatic Impairment Cefepime and zidebactam undergo minimal hepatic metabolism (less than 10%), therefore their systemic clearance is unlikely to be affected by hepatic impairment. Drug Interactions Clinical Studies No drug-drug interactions were observed among cefepime, zidebactam, and metronidazole. In Vitro Studies Cytochrome P450 (CYP) Enzymes : Zidebactam does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4.

Zidebactam does not induce CY… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 19 words ▾

12.1Mechanism of Action Cefepime and zidebactam, components of ZAYNICH, are antibacterial drugs [see Microbiology ( 12.4 )] .

📦 How Supplied / Storage and Handling 129 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ZAYNICH 3 grams (cefepime and zidebactam) for injection is supplied as a white to pale yellow sterile powder for reconstitution. It is packed in a clear USP Type I glass single-dose vial with a rubber stopper (not made with natural rubber latex) and flip-off seal. Each single-dose vial contains 2 grams of cefepime and 1 gram of zidebactam.

NDC: 87706-866-01, carton containing one Single-dose vial. Store ZAYNICH vials refrigerated at 2°C to 8°C (36°F to 46°F); brief excursions are permitted up to 25°C (77°F). Retain the vial in the outer carton prior to and after reconstitution to protect it from light.

Storage after reconstitution and dilution and administration instructions are described elsewhere in the labeling [ see Dosage and Administration ( 2.3 ) ].

📦 Storage and Handling 66 words ▾

NDC: 87706-866-01, carton containing one Single-dose vial. Store ZAYNICH vials refrigerated at 2°C to 8°C (36°F to 46°F); brief excursions are permitted up to 25°C (77°F). Retain the vial in the outer carton prior to and after reconstitution to protect it from light. Storage after reconstitution and dilution and administration instructions are described elsewhere in the labeling [ see Dosage and Administration ( 2.3 ) ].

📋 Description 204 words ▾

11 DESCRIPTION ZAYNICH for injection contains cefepime hydrochloride, a cephalosporin antibacterial drug, and zidebactam, a beta-lactamase inhibitor and non-beta-lactam antibacterial. Cefepime, present as cefepime hydrochloride monohydrate, is a white to pale yellow powder. The chemical name for cefepime hydrochloride monohydrate is 1-[[(6 R ,7 R )-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,7 2 -( Z )-( O- methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Figure 1.

Cefepime Hydrochloride The molecular formula of cefepime hydrochloride monohydrate is C 19 H 25 ClN 6 O 5 S 2 ·HCl·H 2 O and the molecular weight is 571.56. Zidebactam is a white to pale yellow powder. The chemical name of zidebactam is (2 S ,5 R )-7-Oxo-6-sulphooxy-2-[ N '-(( R )-piperidin-3-carbonyl)hydrazinocarbonyl]-1,6-diazabicyclo[3.2.1]octane, dihydrate, which corresponds to the following structural formula: Figure 2.

Zidebactam Zidebactam is freely soluble in water. Its molecular formula is C 13 H 21 N 5 O 7 S·2H 2 O, and its molecular weight is 427.45. ZAYNICH 3 grams (cefepime and zidebactam) for injection is supplied as a white to pale yellow sterile powder for reconstitution.

Each vial contains 2 grams of cefepime (equivalent to 2.3 grams of cefepime hydrochloride), 1 gram of zidebactam, and 1.4 grams of L-arginine. Figure 1. Cefepime Hydrochloride Figure 2.

Zidebactam

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Serious Allergic Reactions Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Advise patients to discontinue ZAYNICH and seek immediate medical attention if allergic reactions occur [see Warnings and Precautions ( 5.1 )] . Neurotoxicity Advise patients of neurological adverse reactions that could occur with ZAYNICH use.

Instruct patients or their caregivers to inform their healthcare provider at once of any neurological signs and symptoms, including encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), aphasia (disturbance of speaking and understanding spoken and written language), myoclonus, seizures and nonconvulsive status epilepticus [see Warnings and Precautions ( 5.2 )] . Potentially Serious Diarrhea Diarrhea is a common problem caused by antibacterial drugs, which usually ends when the antibacterial drug is discontinued.

Inform patients that they may develop watery and bloody stools (with or without stomach cramps and fever) during treatment and as late as two or more months after having taken the last dose of the antibacterial drug. Inform patients that they should contact their physician as soon as possible if this occurs [see Warnings and Precautions ( 5.3 )] . Antibacterial Resistance Counsel patients that antibacterial drugs, including ZAYNICH, should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold). 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 [see Warnings and Precautions ( 5.6 )] . Manufactured by: ACS Dobfar S.p.A.

Via Alessandro Fleming 2 Verona 37135, Italy Manufactured for: Wockhardt Suisse USA LLC 200 Continental DR STE 401 Newark, DE 19713-4337, USA 06/2026

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Pharmacokinetic (PK) Parameters The PK properties of cefepime and zidebactam are summarized in Table 4 as geometric mean (geometric coefficient of variation, GCV%) in healthy adult subjects. Table 4: Pharmacokinetic Parameters (Geometric mean [GCV%]) of Cefepime and Zidebactam AUC 0-8 = area under the plasma concentration time curve from 0 to 8 h; CL = clearance; C max = maximum concentration; GCV = Geometric coefficient of variation; T 1/2 = terminal half-life; Vz = volume of distribution Pharmacokinetic Parameters Cefepime Zidebactam Exposure C max (mg/L) Pharmacokinetic parameters are presented at steady state (Day 10) in healthy subjects at a dosage of 2 grams cefepime and 1 gram zidebactam every 8 hours (geometric mean (GCV%)).

153 (2.6) 64.3 (6.3) AUC 0-8 (mg•h/L) 362 (6.3) 153 (5.6) Distribution % Bound to human plasma protein 20% 4.0-5.4% Vz (L) 13.7 (5.0) 15.5 (10.1) Proportionality (dose range) 0.25 g – 2.0 g 0.25 g – 3.0 g Accumulation Similar pharmacokinetics following single and multiple dosing Elimination CL (L/h) 5.2 (8.5) 6.2 (5.9) T 1/2 (h) 1.8 (12.9) 1.7 (10.8) Metabolism Approximately 6.8% of the administered dose of cefepime is eliminated in urine as N-oxide and 2.5% as cefepime epimer. Approximately 2.5% of the administered dose of zidebactam is eliminated in urine as zidebactam impurity-1 isomer.

Minimally metabolized Excretion Major route of elimination Renal % Excreted unchanged in urine Arithmetic mean. 85% 88% Specific Populations No clinically significant differences in the PK of cefepime and zidebactam were observed based on age (18 to 90 years), weight (39 to 130 kg), gender (59% male, 41% female), or race (0.02% American Indian or Alaska native, 9% Asian, 14% Black or African American, 75% White). Patients with Renal Impairment In a single-dose trial evaluating the effect of renal impairment on the pharmacokinetics of cefepime and zidebactam, dosage was adjusted for subjects with moderate and severe renal impairment (defined as creatinine clearance, CrCl, less than 60 mL/min).

The dose-normalized systemic exposures of cefepime and zidebactam were higher at all levels of renal impairment compared with healthy subjects with creatinine clearance (CrCl, estimated by Cockcroft-Gault) greater than or equal to 90 mL/min, see Table 5 . Table 5: Dose Normalized Fold AUC 0-infinity Increase in Subjects with Renal Impairment Compared with Subjects with Creatinine Clearance (CrCI) ≥ 90 mL/min AUC 0-infinity = area under the plasma concentration time curve from 0 to time infinity; CrCl = Creatinine clearance; ESRD = end stage renal disease; HD = hemodialysis CrCl (mL/min) Cefepime Zidebactam 60 to 89 1.4 1.3 30 to 59 3.0 3.3 15 to 29 4.2

5.4ESRD on HD 9.9

16.0Patients with Hepatic Impairment Cefepime and zidebactam undergo minimal hepatic metabolism (less than 10%), therefore their systemic clearance is unlikely to be affected by hepatic impairment. Drug Interactions Clinical Studies No drug-drug interactions were observed among cefepime, zidebactam, and metronidazole. In Vitro Studies Cytochrome P450 (CYP) Enzymes : Zidebactam does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4.

Zidebactam does not induce CYP1A2, CYP2B6, or CYP3A4. No in vitro CYP450 enzyme drug interaction studies were conducted with cefepime. Membrane Transporter Systems : Zidebactam is not a substrate of BCRP, MRP4, MDR1, OAT1, OAT3 and OCT2.

Zidebactam does not inhibit P-gp, BCRP, OATP1B1, OATP1B3, OCT2, OAT1, OAT3, BSEP and MRP4. Cefepime is not a substrate of MRP4, OAT1, OAT3 and OCT2 transporters. At therapeutic concentrations, cefepime does not inhibit MDR1, OCT2, MRP4, OAT3, OATP1B3, OAT1, OATP1B1, and OCTN2.

🧬 Pharmacodynamics 91 words ▾

12.2Pharmacodynamics For both cefepime and zidebactam, components of ZAYNICH, the percentage of time that unbound drug exceeds the minimum inhibitory concentration (% f T > MIC) has been shown to best correlate with efficacy in animal and in vitro models of infection. Zidebactam alters the pharmacodynamic activity of cefepime, resulting in a reduction of cefepime's % f T > MIC required for antibacterial activity. Cardiac Electrophysiology At 4 times the maximum recommended zidebactam dose given together with the recommended dose for cefepime, clinically significant QTc interval prolongation was not observed.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Complicated Urinary Tract Infections, including Pyelonephritis A total of 530 adults with cUTI, including pyelonephritis, were randomized in a 2:1 ratio in a multinational, double-blind, noninferiority trial (Trial 1, NCT04979806), comparing ZAYNICH (2 grams cefepime and 1 gram of zidebactam) to meropenem (1 gram) both administered intravenously every 8 hours (infused over 1 hour) for 7 to 10 days, for patients with and without bacteremia. The dose adjustments were made for patients with renal impairment. No switch from IV to oral antibacterial therapy was permitted.

The microbiological modified intent-to-treat population (mMITT) was the primary efficacy analysis population, which included all randomized patients who received any study drug, had one or two baseline qualifying pathogen(s) with growth ≥ 10 5 colony-forming-units (CFU)/mL in urine culture or the same pathogen in blood and urine cultures, and excluded patients with pathogens resistant to meropenem. A total of 281 and 136 patients were included in the mMITT population in the ZAYNICH and meropenem treatment groups, respectively.

Patient demographic and baseline characteristics were balanced between treatment groups in the mMITT population. Approximately 90% of patients were White and 55% were male in both treatment groups. The mean age was 65 years in ZAYNICH group and 68 years in meropenem group, with 60% and 66% of patients 65 years of age and older in the ZAYNICH and meropenem treatment groups, respectively.

Mean body mass index was approximately 28 kg/m 2 in ZAYNICH treatment group and 29 kg/m 2 in meropenem group. Concomitant bacteremia was identified in 6% and 7% of patients at baseline in the ZAYNICH and meropenem treatment groups, respectively. The majority of patients (88%) were enrolled in Europe.

Overall, in both treatment groups, 68% of patients had cUTI while 32% of patients had pyelonephritis, with 49% and 19% of patients having a non-removable and removable source of infection, respectively. The median duration of treatment in both treatment groups was 8 days. ZAYNICH demonstrated efficacy with regards to composite response defined as clinical cure and microbiological response, at the Test of Cure (TOC) visit (10 days after the end of treatment) in the mMITT population as shown in Table 6 .

Clinical cure was defined as the complete resolution (or return to premorbid state) of the baseline signs and symptoms of cUTI or pyelonephritis that were present at Screening (and no new urinary symptoms or worsening of symptoms). Microbiological response was defined as the baseline qualifying pathogen(s) reduced to <10 3 CFU/mL in urine. Table 6: Composite Response (Clinical Cure and Microbiological Response) Rates at TOC in Trial 1 of cUTI Including Pyelonephritis (mMITT Population) CI = confidence interval; TOC = Test of Cure Response at TOC visit ZAYNICH n / N (%) Meropenem n / N (%) Difference (%) 95% CI Clinical cure and microbiological Response 250/281 (89.0) 93/136 (68.4) 20.6 (12.3, 29.5) Clinical cure 272/281 (96.8) 129/136 (94.9) 1.9 (-1.9, 7.3) Microbiological Response 256/281 (91.1) 96/136 (70.6) 20.5 (12.6, 29.2) Composite response in patients with bacteremia at baseline was achieved in 16/18 (89%) patients in the ZAYNICH group and 4/9 (44%) patients in the meropenem group at the TOC visit in the mMITT population.

Composite response (microbiological and clinical cure) rates by pathogen for the mMITT population are presented in Table 7 . Table 7: Composite Response (Microbiological Response and Clinical Cure) Rates at TOC by Pathogen in Trial 1 of cUTI Including Pyelonephritis (mMITT Population) Gram-negative Pathogens ZAYNICH n / N (%) Meropenem n / N (%) Escherichia coli 162/176 (92) 60/87 (69) Klebsiella pneumoniae 41/52 (79) 15/24 (63) Proteus mirabilis 22/25 (88) 6/7 (86) Enterobacter cloacae complex 11/13 (85) 4/7 (57) Pseudomonas aeruginosa 4/7 (57) 1/5 (20) In the subset of E. coli , K. pneumoniae , and P. mirabilis is… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term carcinogenicity studies have not been performed with cefepime or zidebactam. Mutagenesis Cefepime In chromosomal aberration studies, cefepime was positive for clastogenicity in primary human lymphocytes, but negative in Chinese hamster ovary cells. In other in vitro assays (bacterial and mammalian cell mutation, DNA repair in primary rat hepatocytes, and sister chromatid exchange in human lymphocytes), cefepime was negative for genotoxic effects.

Moreover, in vivo assessments of cefepime in mice (2 chromosomal aberration and 2 micronucleus studies) were negative for clastogenicity. Zidebactam Zidebactam was negative for genetic toxicity in vitro in a mutagenicity assay in mouse lymphoma cells, and a chromosomal aberration assay in human peripheral blood lymphocytes, and in vivo in a mouse micronucleus assay in bone marrow cells. Impairment of Fertility Cefepime No untoward effects on fertility were observed in rats when cefepime was administered subcutaneously at doses up to 1000 mg/kg/day (1.6 times the recommended human dose for cefepime in ZAYNICH based on body surface area).

Zidebactam In a fertility study, zidebactam was administered in doses of 200, 400, and 800 mg/kg/day in divided doses administered intravenously twice per day to male rats beginning 28 days before mating and through mating, and to female rats beginning 14 days before mating, through mating, and until GD 7. Zidebactam did not impair fertility, reproductive performance, or spermatogenesis in males at doses up to 800 mg/kg/day corresponding to plasma exposures of approximately 4 times the RHD based on plasma AUC comparison.

Fertility, reproductive performance, and early embryonic development in females was not affected at doses up to 800 mg/kg/day corresponding to plasma AUC exposures of approximately 2 times the RHD based on plasma AUC comparison.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term carcinogenicity studies have not been performed with cefepime or zidebactam. Mutagenesis Cefepime In chromosomal aberration studies, cefepime was positive for clastogenicity in primary human lymphocytes, but negative in Chinese hamster ovary cells. In other in vitro assays (bacterial and mammalian cell mutation, DNA repair in primary rat hepatocytes, and sister chromatid exchange in human lymphocytes), cefepime was negative for genotoxic effects.

Moreover, in vivo assessments of cefepime in mice (2 chromosomal aberration and 2 micronucleus studies) were negative for clastogenicity. Zidebactam Zidebactam was negative for genetic toxicity in vitro in a mutagenicity assay in mouse lymphoma cells, and a chromosomal aberration assay in human peripheral blood lymphocytes, and in vivo in a mouse micronucleus assay in bone marrow cells. Impairment of Fertility Cefepime No untoward effects on fertility were observed in rats when cefepime was administered subcutaneously at doses up to 1000 mg/kg/day (1.6 times the recommended human dose for cefepime in ZAYNICH based on body surface area).

Zidebactam In a fertility study, zidebactam was administered in doses of 200, 400, and 800 mg/kg/day in divided doses administered intravenously twice per day to male rats beginning 28 days before mating and through mating, and to female rats beginning 14 days before mating, through mating, and until GD 7. Zidebactam did not impair fertility, reproductive performance, or spermatogenesis in males at doses up to 800 mg/kg/day corresponding to plasma exposures of approximately 4 times the RHD based on plasma AUC comparison.

Fertility, reproductive performance, and early embryonic development in females was not affected at doses up to 800 mg/kg/day corresponding to plasma AUC exposures of approximately 2 times the RHD based on plasma AUC comparison.

📄 Package Label / Principal Display Panel 61 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL VIAL LABEL NDC: 87706-866-00 single-dose vial Zaynich™ 3 g per vial* (cefepime and zidebactam) for injection For intravenous infusion after reconstitution and dilution Rx only WOCKHARDT MONO CARTON NDC: 87706-866-01 1 single-dose vial Zaynich™ 3 g per vial* (cefepime and zidebactam) for injection For intravenous infusion after reconstitution and dilution Rx only WOCKHARDT VIAL LABEL MONO CARTON

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

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 ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 Wockhardt Suisse USA LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Wockhardt Suisse USA LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 87704-0004-01 · Guangzhou 87708-0002-04 · LEON →
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.