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ZINPLAVA bezlotoxumab 25 mg/mL Injection, Solution — NDC 00006-3025-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ZINPLAVA bezlotoxumab 25 mg/mL Injection, Solution — NDC 0006-3025-00 (Billing 00006-3025-00)

by Merck Sharp & Dohme LLC · 1 VIAL, SINGLE-DOSE in 1 CARTON / 40 mL in 1 VIAL, SINGLE-DOSE

This is a package of ZINPLAVA bezlotoxumab 25 mg/mL Injection, Solution from Merck Sharp & Dohme LLC, marketed since Oct 2016 and currently FDA-listed. It is this product's only package size.

NDC 00006-3025-00
🏷️ FDA NDC (as labeled) 0006-3025-00 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 0006-3025-00 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0006 labeler · 3025 product · 00 package
Package marketed since
Oct 21, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0006302500 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0006-3025-00
Product NDC 0006-3025
11-digit billing NDC 00006302500
NCPDP billing unit ML — per mL (volume)
RxCUI 1855052, 1855057
UNII 4H5YMK1H2E
Application # BLA761046
SPL Set ID 8f479bfe-2bfa-4cc5-9aee-1357364480b0
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-10-21
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance BEZLOTOXUMAB
Biologic (Purple Book) 351(a)

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

GPI-14 19503015002020
GPI class Zinplava
GCN Seq No 076789
GCN 42584
HICL code 043884
Ingredient (HICL) Bezlotoxumab
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W2
Therapeutic class — intermediate (HIC2) Antibacterials
HIC3 code W2H
Therapeutic class — specific (HIC3) Antibacterial Monoclonal Antibodies
AHFS code 80:04.00.00
AHFS class Antitoxins And Immune Globulins
FDB label name ZINPLAVA 1,000 MG/40 ML VIAL
FDB brand name Zinplava
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 076789
  • GCN: 42584
  • GPI-14 (Medi-Span): 19503015002020
  • HICL (First Databank): 043884
  • AHFS class code: 80:04.00.00
  • RxCUI (RxNorm): 1855052
Why two NDCs? The FDA registers this code as 0006-3025-00 — 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 → 00006-3025-00. 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 Antibacterial monoclonal antibodies class.

Drug family (ATC) Antibacterial monoclonal antibodies
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 ZINPLAVA 1,000 MG/40 ML VIAL Ingredient Bezlotoxumab
📖 What it is MedlinePlus · NLM

Bezlotoxumab injection is used to decrease the risk of Clostridium difficile infection (C. difficile or CDI; a type of bacteria that can cause severe or life-threatening diarrhea) from coming back in people who are at high risk for C. difficile infection and who are already taking an antibiotic drug to treat Clostridium difficile. Bezlotoxumab is in a class of medications called monoclonal antibodies. It works by binding to a C. difficile toxin to stop its effects on the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It helps lower the chance that a C. difficile infection comes back. You get it while taking antibiotics for the infection. It does not treat the infection by itself.
  • It is given once through an IV over about 60 minutes by a healthcare professional. The dose depends on your weight. You do not need to take it at home.
  • The most common are nausea, fever and headache. Some people feel tired, dizzy or short of breath during or just after the infusion. These usually pass within a day.
  • Heart failure was reported more often in people with a history of congestive heart failure who received it. Your doctor should use it only if the benefit outweighs the risk. Tell u...
📖 Read our full Bezlotoxumab Injection 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 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
00006-3025-00 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 40 mL in 1 VIAL, SINGLE-DOSE 2016-10-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zinplava 25 mg/mLthis 00006-3025-00 Merck 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
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 & biosimilar status

🏛️
2016
First FDA approval
Oct 2016
📍
2026
Currently FDA-listed
10 years listed
🛡️
2028
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2028. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 21, 2016 ⏳ ~2 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Zinplavabezlotoxumab
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2016 2018 2020 2022 2024 2026 2028
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateOct 21, 2028
Common questions
Is there a biosimilar for ZINPLAVA 1,000 MG/40 ML VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, 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 Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

What it looks like

Color Yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 Bezlotoxumab Injection 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.

  • 0.8 mg / 1 mL UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 0.0078 mg / 1 mL UNII 7A314HQM0I
    Pentetic acid is a chelating agent, a chemical that binds to metals. It's used in some medicines to prevent metal ions from interfering with drug stability or effectiveness.
  • 0.25 mg / 1 mL UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 8.77 mg / 1 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 4.75 mg / 1 mL UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • 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.

7 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

LabelerMerck Sharp & Dohme LLC
FDA applicationBLA761046 (BLA)
Labeler code00006
First marketedOct 2016
Product typeHuman Prescription Drug
Portfolio112 products on file

More NDCs from Merck Sharp & Dohme LLC labeler code 00006

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 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 167 words ▾

1 INDICATIONS AND USAGE ZINPLAVA™ is indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence. ZINPLAVA is a human monoclonal antibody that binds to Clostridioides difficile toxin B, indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at a high risk for CDI recurrence.

( 1 ) Limitation of Use: ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI.

( 1 ) Limitation of Use: ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI. [See Dosage and Administration (2.1) .]

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Administer ZINPLAVA during antibacterial drug treatment for CDI. ( 2.1 ) The recommended dose is a single dose of 10 mg/kg administered as an intravenous infusion over 60 minutes. ( 2.2 ) Dilute prior to intravenous infusion. Administer via a low-protein binding 0.2 micron to 5 micron in-line or add-on filter. See Full Prescribing Information for dilution and administration instructions. ( 2.3 )

2.1Important Administration Instructions Administer ZINPLAVA during antibacterial drug treatment for CDI.

2.2Dosing Recommendations in Adults and Pediatric Patients 1 year of age and older The recommended dose of ZINPLAVA is a single dose of 10 mg/kg administered as an intravenous infusion over 60 minutes. The safety and efficacy of repeat administration of ZINPLAVA in patients with CDI have not been studied.

2.3Preparation and Administration Preparation of Diluted Solution ZINPLAVA must be diluted prior to intravenous infusion. Prepare the diluted solution immediately after removal of the vial(s) from refrigerated storage, or the vial(s) may be stored at room temperature protected from light for up to 24 hours prior to preparation of the diluted solution. Inspect vial contents for discoloration and particulate matter prior to dilution.

ZINPLAVA is a clear to moderately opalescent, colorless to pale yellow solution. Do not use the vial if the solution is discolored or contains visible particles. Do not shake the vial.

Withdraw the required volume from the vial(s) based on the patient's weight (in kg) and transfer into an intravenous bag containing either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to prepare a diluted solution with a final concentration ranging from 1 mg/mL to 10 mg/mL. Mix diluted solution by gentle inversion. Do not shake.

Discard vial(s) and all unused contents. Storage of Diluted Solution The product does not contain preservative. The diluted solution of ZINPLAVA may be stored either at room temperature for up to 16 hours or under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 24 hours.

If refrigerated, allow the intravenous bag to come to room temperature prior to use. These time limits include storage of the infusion solution in the intravenous bag through the duration of infusion. Do not freeze the diluted solution.

Administration Administer the diluted solution as an intravenous infusion over 60 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter. The diluted solution can be infused via a central line or peripheral catheter. Do not administer ZINPLAVA as an intravenous push or bolus.

Do not co-administer other drugs simultaneously through the same infusion line.

💊 Dosage Forms and Strengths 39 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 1,000 mg/40 mL (25 mg/mL) clear to moderately opalescent, colorless to pale yellow solution in a single-dose vial. Injection : 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions 182 words ▾

5 WARNINGS AND PRECAUTIONS Heart Failure : Was reported more commonly in ZINPLAVA-treated patients with a history of congestive heart failure (CHF) in Trial 1 and Trial 2. In patients with a history of CHF, ZINPLAVA should be reserved for use when the benefit outweighs the risk. ( 5.1 )

5.1Heart Failure Heart failure was reported more commonly in Trial 1 and Trial 2 in ZINPLAVA-treated patients compared to placebo-treated patients. These adverse reactions occurred primarily in patients with underlying congestive heart failure (CHF). In patients with a history of CHF, 12.7% (15/118) of ZINPLAVA-treated patients and 4.8% (5/104) of placebo-treated patients had the serious adverse reaction of heart failure during the 12-week study period [see Adverse Reactions (6.1) ] .

Additionally, in patients with a history of CHF, there were more deaths in ZINPLAVA-treated patients, 19.5% (23/118) than in placebo-treated patients, 12.5% (13/104) during the 12-week study period. The causes of death varied and included cardiac failure, infections, and respiratory failure. In patients with a history of CHF, ZINPLAVA should be reserved for use when the benefit outweighs the risk.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Adult Patients : The most common adverse reactions (reported in ≥4% of adult patients) included nausea, pyrexia, and headache. ( 6.1 ) Pediatric Patients : The most common adverse reactions (reported in >10% of pediatric patients) were pyrexia and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Experience in Adults The safety of ZINPLAVA was evaluated in two placebo-controlled Phase 3 trials (Trial 1 n=390 and Trial 2 n=396). Patients received a single 10 mg/kg intravenous infusion of ZINPLAVA and concomitant standard of care (SoC) antibacterial drugs (metronidazole, vancomycin or fidaxomicin) for CDI.

Adverse reactions reported within the first 4 weeks after ZINPLAVA was administered are described for the pooled Phase 3 trial population of 786 patients. The median age of patients receiving ZINPLAVA was 65 years (range 18 to 100), 50% were age 65 years or older, 56% were female, and 83% were white. Serious Adverse Reactions in Adults Serious adverse reactions occurring within 12 weeks following infusion were reported in 29% of ZINPLAVA-treated patients and 33% of placebo-treated patients.

Heart failure was reported as a serious adverse reaction in 2.3% of the ZINPLAVA-treated patients and 1.0% of the placebo-treated patients [see Warnings and Precautions (5.1) ] . One patient discontinued the ZINPLAVA infusion due to ventricular tachyarrhythmia that occurred 30 minutes after the start of the infusion. Mortality rates were 7.1% and 7.6% in ZINPLAVA-treated patients and placebo-treated patients, respectively, during the 12-week follow-up period.

Most Common Adverse Reactions in Adults The most common adverse reactions following treatment with ZINPLAVA (reported in ≥4% of patients within the first 4 weeks of infusion and with a frequency greater than placebo) were nausea, pyrexia, and headache (see Table 1 ). Table 1: Adverse Reactions Reported in ≥4% of ZINPLAVA-Treated Patients with CDI and at a Frequency Greater than Placebo in Trial 1 and Trial 2 All patients as treated population, defined as all randomized patients who received a dose of study medication, by treatment received , Adverse reactions reported within 4 weeks of administration of ZINPLAVA or placebo Adverse Reaction ZINPLAVA with SoC SoC = Standard of Care antibacterial drugs (metronidazole or vancomycin or fidaxomicin) for CDI N=786 % Placebo with SoC N=781 % Gastrointestinal disorders Nausea 7% 5% General disorders and administration site conditions Pyrexia 5% 3% Nervous system disorders Headache 4% 3% Infusion Related Adverse Reactions in Adults Overall, 10% of ZINPLAVA-treated patients experienced one or more infusion specific adverse reactions on the day of, or the day after, the infusion compared to 8% of placebo-treated patients.

Infusion specific adverse reactions reported in ≥0.5% of patients receiving ZINPLAVA and at a frequency greater than placebo were nausea (3%), fatigue (1%), pyrexia (1%), dizziness (1%), headache (2%), dyspnea (1%) and hypertension (1%). Of these patients, 78% and 20% of patients experienced mild and moderate adverse reactions, respectively. These reactions resolved within 24 hours following onset.

Clinical Trial Experience in Pediatric Patients The safety and pharmacokinetics of ZINPLAVA in pediatric patients 1 year of age and older were evaluated in a randomized, double-blind, placebo-controlled, multi-center trial (Trial 3). Enrolled patients had a diagnosis of CDI and received SoC (vancomycin, metronidazole, or fidaxomicin) for the baseline CDI episode. In this trial, 143 patients were randomized… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 21 words ▾

7 DRUG INTERACTIONS Since ZINPLAVA is eliminated by catabolism, no metabolic drug-drug interactions are expected [see Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Adequate and well controlled studies with ZINPLAVA have not been conducted in pregnant women. No animal reproductive and developmental studies have been conducted with bezlotoxumab. The background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.

8.2Lactation Risk Summary There is no information regarding the presence of bezlotoxumab in human milk, the effects on the breast-fed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ZINPLAVA and any potential adverse effects on the breastfed child from ZINPLAVA or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of ZINPLAVA to reduce recurrence of CDI have been established in pediatric patients 1 year of age and older. Use of ZINPLAVA in pediatric patients 1 year of age and older is supported by evidence from adequate and well-controlled trials in adults with additional pharmacokinetic and safety data in pediatric patients aged 1 year and older. The adverse reactions and the pharmacokinetics observed in pediatric patients were comparable to that observed in adult patients [see Adverse Reactions (6.1) and Clinical Pharmacology (12.3) ] .

The safety and effectiveness of ZINPLAVA have not been established in pediatric patients younger than 1 year of age.

8.5Geriatric Use Of the 786 patients treated with ZINPLAVA, 50% were 65 years of age and over, and 27% were 75 years of age and over. No overall differences in safety and efficacy were observed between these subjects and younger subjects [see Clinical Studies (14) ] . No dose adjustment is necessary for patients ≥65 years of age [see Clinical Pharmacology (12.3) ] .

🤰 Pregnancy 68 words ▾

8.1Pregnancy Risk Summary Adequate and well controlled studies with ZINPLAVA have not been conducted in pregnant women. No animal reproductive and developmental studies have been conducted with bezlotoxumab. The background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.

🧒 Pediatric Use 110 words ▾

8.4Pediatric Use The safety and effectiveness of ZINPLAVA to reduce recurrence of CDI have been established in pediatric patients 1 year of age and older. Use of ZINPLAVA in pediatric patients 1 year of age and older is supported by evidence from adequate and well-controlled trials in adults with additional pharmacokinetic and safety data in pediatric patients aged 1 year and older. The adverse reactions and the pharmacokinetics observed in pediatric patients were comparable to that observed in adult patients [see Adverse Reactions (6.1) and Clinical Pharmacology (12.3) ] .

The safety and effectiveness of ZINPLAVA have not been established in pediatric patients younger than 1 year of age.

🧓 Geriatric Use 65 words ▾

8.5Geriatric Use Of the 786 patients treated with ZINPLAVA, 50% were 65 years of age and over, and 27% were 75 years of age and over. No overall differences in safety and efficacy were observed between these subjects and younger subjects [see Clinical Studies (14) ] . No dose adjustment is necessary for patients ≥65 years of age [see Clinical Pharmacology (12.3) ] .

🆘 Overdosage 34 words ▾

10 OVERDOSAGE There is no clinical experience with overdosage of ZINPLAVA. In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment should be instituted.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action ZINPLAVA (bezlotoxumab) is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects [see Microbiology (12.4) ] .

12.3Pharmacokinetics The pharmacokinetics of bezlotoxumab were studied in 1515 adult CDI patients in two Phase 3 trials (Trial 1 and Trial 2). Based on a population PK analysis, the geometric mean (%CV) clearance of bezlotoxumab was 0.317 L/day (41%), with a mean volume of distribution of

7.33L (16%), and elimination half-life (t½) of approximately 19 days (28%). After a single intravenous dose of 10 mg/kg ZINPLAVA, geometric mean AUC 0-INF and C max were 53000 mcg∙h/mL and 185 mcg/mL, respectively, in the adult patients with CDI. The clearance of bezlotoxumab increased with increasing body weight; the resulting exposure differences are adequately addressed by the administration of a weight-based dose.

Bezlotoxumab is eliminated by catabolism. Specific Populations Gender, Race, Ethnicity, and Co-Morbid Conditions The following factors had no clinically meaningful effect on the exposure of bezlotoxumab in adults: gender, race, ethnicity, and presence of co-morbid conditions. Patients with Renal Impairment The effect of renal impairment on the pharmacokinetics of bezlotoxumab was evaluated in adult patients with mild (eGFR 60 to <90 mL/min/1.73 m 2 ), moderate (eGFR 30 to <60 mL/min/1.73 m 2 ), or severe (eGFR 15 to <30 mL/min/1.73 m 2 ) renal impairment, or with end stage renal disease (eGFR <15 mL/min/1.73 m 2 ), as compared to adult patients with normal (eGFR ≥90 mL/min/1.73 m 2 ) renal function.

No clinically meaningful differences in the exposure of bezlotoxumab were found between adult patients with renal impairment and adult patients with normal renal function. Patients with Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of bezlotoxumab was evaluated in adult patients with hepatic impairment (defined as having two or more of the following: [1] albumin ≤3.1 g/dL; [2] ALT ≥2× ULN; [3] total bilirubin ≥1.3× ULN; or [4] mild, moderate or severe liver disease as reported by the Charlson Co-morbidity Index), as compared to adult patients with normal hepatic function.

No clinically meaningful differences in the exposure of bezlotoxumab were found between adult patients with hepatic impairment and adult patients with normal hepatic function. Geriatric Patients The effect of age on the pharmacokinetics of bezlotoxumab was evaluated in patients ranging from 18 to 100 years of age. No clinically meaningful differences in the exposure of bezlotoxumab were found between patients 65 years and older and patients under 65 years of age.

Pediatric Patients The pharmacokinetics of bezlotoxumab were studied in 90 pediatric patients (1 year to less than 18 years) and after a single intravenous dose of 10 mg/kg ZINPLAVA, geometric mean (%CV) AUC 0-INF and C max were 47,900 (35.9) mcg·h/mL and 139 (32.4) mcg/mL, respectively. There is no clinically meaningful relationship between bezlotoxumab exposure and body weight following weight-based dosing of ZINPLAVA in pediatric patients. Drug Interaction Studies Because bezlotoxumab is eliminated by catabolism, no metabolic drug-drug interactions are expected.

12.4Microbiology Mechanism of Action Bezlotoxumab is a human monoclonal antibody that binds C. difficile toxin B with an equilibrium dissociation constant (K d ) of <1×10 -9 M. Bezlotoxumab inhibits the binding of toxin B and prevents its effects on mammalian cells. Bezlotoxumab does not bind to C. difficile toxin A.

Activity In Vitro Bezlotoxumab binds to an epitope on toxin B that is conserved across reported strains of C. difficile , although amino acid sequence variation within the epitope does occur. In vitro studies in cell-based assays using Vero cells or Caco-2 cells, suggest that bezlotoxumab neutralizes the toxic effects of toxin B.

12.6Immunogenicity The observed incidence of anti-drug antibodies (ADA) is hig… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 77 words ▾

12.1Mechanism of Action ZINPLAVA (bezlotoxumab) is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects [see Microbiology (12.4) ] .

Mechanism of Action Bezlotoxumab is a human monoclonal antibody that binds C. difficile toxin B with an equilibrium dissociation constant (K d ) of <1×10 -9 M. Bezlotoxumab inhibits the binding of toxin B and prevents its effects on mammalian cells. Bezlotoxumab does not bind to C. difficile toxin A.

📦 How Supplied / Storage and Handling 66 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ZINPLAVA Injection: is a sterile, preservative-free, clear to moderately opalescent, colorless to pale yellow solution and is supplied in the following packaging configuration: Carton (NDC 0006-3025-00) containing one (1) single-dose vial of ZINPLAVA 1,000 mg/40 mL (25 mg/mL). Store in a refrigerator, 2ºC to 8ºC (36ºF to 46ºF) in original carton to protect from light. Do Not Freeze. Do Not Shake.

📦 Storage and Handling 23 words ▾

Store in a refrigerator, 2ºC to 8ºC (36ºF to 46ºF) in original carton to protect from light. Do Not Freeze. Do Not Shake.

📋 Description 122 words ▾

11 DESCRIPTION Bezlotoxumab is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects. Bezlotoxumab is an IgG 1 immunoglobulin with an approximate molecular weight of 148.2 kDa. ZINPLAVA (bezlotoxumab) Injection is a sterile, preservative-free, clear to moderately opalescent, colorless to pale yellow solution that requires dilution for intravenous infusion.

The product is provided in a 50 mL vial that contains 1000 mg of bezlotoxumab in 40 mL of solution. Each mL of solution contains bezlotoxumab (25 mg), citric acid monohydrate (0.8 mg), diethylenetriaminepentaacetic acid (0.0078 mg), polysorbate 80 (0.25 mg), sodium chloride (8.77 mg), sodium citrate dihydrate (4.75 mg), and Water for Injection, USP. The vial may contain sodium hydroxide to adjust the pH to 6.0.

💬 Information for Patients 59 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Concurrent Antibacterial Therapy Advise patients, their families, or caregivers that ZINPLAVA does not take the place of their antibacterial treatment for their CDI infection. They must continue their antibacterial treatment as directed [see Indications and Usage (1) and Dosage and Administration (2.1) ] .

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics The pharmacokinetics of bezlotoxumab were studied in 1515 adult CDI patients in two Phase 3 trials (Trial 1 and Trial 2). Based on a population PK analysis, the geometric mean (%CV) clearance of bezlotoxumab was 0.317 L/day (41%), with a mean volume of distribution of

7.33L (16%), and elimination half-life (t½) of approximately 19 days (28%). After a single intravenous dose of 10 mg/kg ZINPLAVA, geometric mean AUC 0-INF and C max were 53000 mcg∙h/mL and 185 mcg/mL, respectively, in the adult patients with CDI. The clearance of bezlotoxumab increased with increasing body weight; the resulting exposure differences are adequately addressed by the administration of a weight-based dose.

Bezlotoxumab is eliminated by catabolism. Specific Populations Gender, Race, Ethnicity, and Co-Morbid Conditions The following factors had no clinically meaningful effect on the exposure of bezlotoxumab in adults: gender, race, ethnicity, and presence of co-morbid conditions. Patients with Renal Impairment The effect of renal impairment on the pharmacokinetics of bezlotoxumab was evaluated in adult patients with mild (eGFR 60 to <90 mL/min/1.73 m 2 ), moderate (eGFR 30 to <60 mL/min/1.73 m 2 ), or severe (eGFR 15 to <30 mL/min/1.73 m 2 ) renal impairment, or with end stage renal disease (eGFR <15 mL/min/1.73 m 2 ), as compared to adult patients with normal (eGFR ≥90 mL/min/1.73 m 2 ) renal function.

No clinically meaningful differences in the exposure of bezlotoxumab were found between adult patients with renal impairment and adult patients with normal renal function. Patients with Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of bezlotoxumab was evaluated in adult patients with hepatic impairment (defined as having two or more of the following: [1] albumin ≤3.1 g/dL; [2] ALT ≥2× ULN; [3] total bilirubin ≥1.3× ULN; or [4] mild, moderate or severe liver disease as reported by the Charlson Co-morbidity Index), as compared to adult patients with normal hepatic function.

No clinically meaningful differences in the exposure of bezlotoxumab were found between adult patients with hepatic impairment and adult patients with normal hepatic function. Geriatric Patients The effect of age on the pharmacokinetics of bezlotoxumab was evaluated in patients ranging from 18 to 100 years of age. No clinically meaningful differences in the exposure of bezlotoxumab were found between patients 65 years and older and patients under 65 years of age.

Pediatric Patients The pharmacokinetics of bezlotoxumab were studied in 90 pediatric patients (1 year to less than 18 years) and after a single intravenous dose of 10 mg/kg ZINPLAVA, geometric mean (%CV) AUC 0-INF and C max were 47,900 (35.9) mcg·h/mL and 139 (32.4) mcg/mL, respectively. There is no clinically meaningful relationship between bezlotoxumab exposure and body weight following weight-based dosing of ZINPLAVA in pediatric patients. Drug Interaction Studies Because bezlotoxumab is eliminated by catabolism, no metabolic drug-drug interactions are expected.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Clinical Trials in Adults The safety and efficacy of ZINPLAVA were investigated in two randomized, double-blind, placebo-controlled, multicenter, Phase 3 trials (Trial 1 and Trial 2) in patients receiving Standard of Care antibacterial drugs for treatment of CDI (SoC). Randomization was stratified by SoC (metronidazole, vancomycin, or fidaxomicin) and hospitalization status (inpatient vs. outpatient) at the time of study entry. Enrolled patients were 18 years of age or older and had a confirmed diagnosis of CDI, which was defined as diarrhea (passage of 3 or more loose bowel movements in 24 or fewer hours) and a positive stool test for toxigenic C. difficile from a stool sample collected no more than 7 days before study entry.

Patients were excluded if surgery for CDI was planned, or if they had uncontrolled chronic diarrheal illness. Patients received a 10- to 14-day course of oral SoC and a single infusion of ZINPLAVA or placebo was administered during the course of SoC. Patients on oral vancomycin or oral fidaxomicin could have also received intravenous metronidazole.

Choice of SoC was at the discretion of the health care provider. The day of the infusion of ZINPLAVA or placebo in relation to the start of SoC ranged from the day prior to the start of SoC to 14 days after the start of SoC with the median being day 3 of SoC. In Trial 1, 403 patients were randomized to receive ZINPLAVA and 404 patients were randomized to receive placebo.

In Trial 2, 407 subjects were randomized to receive ZINPLAVA and 399 patients were randomized to receive placebo. The Full Analysis Set (FAS) was a subset of all randomized subjects with exclusions for: (i) not receiving infusion of study medication; (ii) not having a positive local stool test for toxigenic C. difficile ; (iii) not receiving protocol defined standard of care therapy within a 1 day window of the infusion. The baseline characteristics of the 1554 patients randomized to ZINPLAVA or placebo in the FAS were similar across treatment arms and in Trial 1 and Trial 2.

The median age was 65 years, 85% were white, 57% were female, and 68% were inpatients. A similar proportion of patients received oral metronidazole (48%) or oral vancomycin (48%) and 4% of the patients received oral fidaxomicin as their SoC. The following risk factors associated with a high risk of CDI recurrence or CDI-related adverse outcomes were present in the study population: 51% were ≥65 years of age, 39% received one or more systemic antibacterial drugs (during the 12-week follow-up period), 28% had one or more episodes of CDI within the six months prior to the episode under treatment (15% had two or more episodes prior to the episode under treatment), 21% were immunocompromised and 16% presented at study entry with clinically severe CDI (as defined by a Zar score of ≥2 1 ).

A hypervirulent strain (ribotypes 027, 078 or 244) was isolated in 22% of patients who had a positive baseline culture, of which 87% (189 of 217 strains) were ribotype 027. Patients were assessed for clinical cure of the presenting CDI episode, defined as no diarrhea for 2 consecutive days following the completion of a ≤14 day SoC regimen. Patients who achieved clinical cure were then assessed for recurrence of CDI through 12 weeks following administration of the infusion of ZINPLAVA or placebo.

CDI recurrence was defined as the development of a new episode of diarrhea associated with a positive stool test for toxigenic C. difficile following clinical cure of the presenting CDI episode. Sustained clinical response was defined as clinical cure of the presenting CDI episode and no CDI recurrence through 12 weeks after infusion. Table 2 contains the results for Trial 1 and Trial 2.

Table 2: Efficacy Results Through 12 Weeks After Infusion (Trial 1 and Trial 2, Full Analysis Set Full Analysis Set = a subset of all randomized subjects with exclusions for: (i) did not receive infusion of study medication; (ii) did not have a posi… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 32 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to test the potential of bezlotoxumab for carcinogenicity or genotoxicity. Fertility studies have not been conducted with bezlotoxumab.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 29 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to test the potential of bezlotoxumab for carcinogenicity or genotoxicity. Fertility studies have not been conducted with bezlotoxumab.

📚 References 32 words ▾

15 REFERENCES Zar FA, Bakkanagari SR, Moorthi KM, Davis MB. A comparison of vancomycin and metronidazole for the treatment of Clostridium difficile -associated diarrhea, stratified by disease severity. Clin Infect Dis 2007;45(3):302-7.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 5/2023 Patient Information ZINPLAVA™ (zin-PLAH-va) (bezlotoxumab) injection, for intravenous use What is ZINPLAVA?

ZINPLAVA is a prescription medicine used to help decrease the risk of C-diff ( Clostridioides difficile infection) from coming back in adults and children 1 year of age and older who are taking an antibiotic for C-diff and who have a high risk of C-diff coming back. ZINPLAVA is not used to treat C-diff and is not an antibiotic. ZINPLAVA should only be used along with the antibiotic that you are taking to treat C-diff.

Keep taking your antibiotic for your C-diff as directed by your doctor. It is not known if ZINPLAVA is safe and effective in children under 1 year of age. Before receiving ZINPLAVA, tell your doctor about all of your medical conditions, including if you: have or have had congestive heart failure (CHF). are pregnant or trying to get pregnant.

It is not known if ZINPLAVA will harm your unborn baby. You and your doctor should decide together if you will receive ZINPLAVA. are breastfeeding or plan to breastfeed. It is not known if ZINPLAVA passes into your breast milk.

You and your doctor should decide together if you will receive ZINPLAVA. Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive ZINPLAVA?

You will receive ZINPLAVA into your vein through an IV (intravenously). You do not need to do anything to prepare for receiving ZINPLAVA. You will receive ZINPLAVA in 1 dose and it will take about 1 hour.

If you miss your appointment, call your doctor right away to reschedule it. What are the possible side effects of ZINPLAVA? ZINPLAVA may cause serious side effects, including: Heart failure.

Heart failure may happen in people who receive ZINPLAVA and can be serious. People with a history of congestive heart failure (CHF) who received ZINPLAVA had a higher rate of heart failure and death than those who did not receive ZINPLAVA. Common side effects of ZINPLAVA: The most common side effects that may happen on the day of or the day after receiving ZINPLAVA include: nausea headache fever feeling tired shortness of breath feeling dizzy high blood pressure The most common side effects that may happen up to four weeks after receiving ZINPLAVA include: nausea fever headache If you have any side effect that bothers you or does not go away, tell your doctor.

These are not all the possible side effects of ZINPLAVA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of ZINPLAVA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

You can ask your pharmacist or doctor for information about ZINPLAVA that is written for health professionals. What are the ingredients in ZINPLAVA? The active ingredient is : bezlotoxumab The inactive ingredients are : citric acid monohydrate, diethylenetriaminepentaacetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, and water for injection, USP.

ZINPLAVA may also contain sodium hydroxide. For more information, call the company that makes ZINPLAVA, at 1-800-444-2080, or go to the website – www.ZINPLAVA.com . You can also find the full prescribing information written for health professionals at www.ZINPLAVA.com Manufactured by: Merck Sharp & Dohme LLC Rahway, NJ 07065, USA U.S.

License No. 0002 At: MSD Ireland (Carlow) County Carlow, Ireland For patent information: www.msd.com/research/patent Copyright © 2016-2023 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates All rights reserved. usppi-mk6072-iv-2305r002

📄 Recent Major Changes 27 words ▾

Indications and Usage ( 1 ) 5/2023 Dosage and Administration, Dosing Recommendations in Adults and Pediatric Patients 1 year of age and older ( 2.2 ) 5/2023

📄 Package Label / Principal Display Panel 47 words ▾

PRINCIPAL DISPLAY PANEL - 1,000 mg/40 mL Vial Carton NDC 0006-3025-00 Zinplava ™ (bezlotoxumab) Injection 1,000 mg / 40 mL (25 mg/mL) For Intravenous Infusion Only Requires dilution prior to administration. Rx only Single-dose vial. Discard unused portion. PRINCIPAL DISPLAY PANEL - 1,000 mg/40 mL Vial Carton

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

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Zinplava — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Zinplava. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$102.8K
Claims incl. refills
25
Beneficiaries
25
Spend / beneficiary
$4,113.72
Spend / claim
$4,113.72
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ 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 Merck Sharp & Dohme LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Merck Sharp & Dohme 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.
← 00006-0577-03 · Merck 00006-3026-02 · Merck →
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.