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ENFLONSIA CLESROVIMAB 150 mg/mL Injection, Solution, 1 syringe — NDC 00006-5073-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ENFLONSIA CLESROVIMAB 150 mg/mL Injection, Solution, 1 syringe — NDC 0006-5073-01 (Billing 00006-5073-01)

by Merck Sharp & Dohme LLC · 1 SYRINGE, GLASS in 1 CARTON / .7 mL in 1 SYRINGE, GLASS

This is a package of 1 syringe of ENFLONSIA CLESROVIMAB 150 mg/mL Injection, Solution from Merck Sharp & Dohme LLC, marketed since Jun 2025 and currently FDA-listed.

NDC 00006-5073-01
🏷️ FDA NDC (as labeled) 0006-5073-01 billing pads the labeler segment with a zero
This package
Contains1 syringe Medicaid pays$60.65 / unit · 12 mo Per package$42.46 / 0.7 ml · Medicaid Pack sizes2 compare ↓
Product page 00006-5073-02 Also comes in: 10 syringes 0006-5073-02
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 0006-5073-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0006 labeler · 5073 product · 01 package
Package marketed since
Jun 9, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0006507301 9
Medicaid fills, this package
29 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0006-5073-01
Product NDC 0006-5073
11-digit billing NDC 00006507301
NCPDP billing unit ML — per mL (volume)
RxCUI 2716809, 2716816
UNII VJO29R4CP9
Application # BLA761432
SPL Set ID c9004a92-40e8-4cdb-b22d-d07929f8fc3b
Established class (EPC) Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody
Mechanism of action Fusion Protein Inhibitors
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-09
Route INTRAMUSCULAR
Dosage form INJECTION, SOLUTION
Substance CLESROVIMAB
Biologic (Purple Book) 351(a)

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

GPI-14 1950202600E520
GCN Seq No 087843
GCN 57865
HICL code 050633
Ingredient (HICL) Clesrovimab-Cfor
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W5D
Therapeutic class — specific (HIC3) Antiviral Monoclonal Antibodies
AHFS code 08:18.24.00
AHFS class Monoclonal Antibodies (08:18)
FDB label name ENFLONSIA 105 MG/0.7 ML SYRNG
FDB brand name Enflonsia
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 087843
  • GCN: 57865
  • GPI-14 (Medi-Span): 1950202600E520
  • HICL (First Databank): 050633
  • AHFS class code: 08:18.24.00
  • RxCUI (RxNorm): 2716809
Why two NDCs? The FDA registers this code as 0006-5073-01 — 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 → 00006-5073-01. 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 Antiviral monoclonal antibodies class.

Drug family (ATC) Antiviral 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 ENFLONSIA 105 MG/0.7 ML SYRNG Ingredient Clesrovimab-Cfor
📖 What it is MedlinePlus · NLM

Clesrovimab-cfor is used to prevent lung disease caused by Respiratory Syncytial Virus (RSV) infection in neonates or infants in their first RSV season (usually November through April in most parts of the United States). Clesrovimab-cfor is in a class of medications called monoclonal antibodies. It works by preventing RSV from infecting cells and causing disease.

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 $60.65 $42.46 / 0.7 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
00006-5073-01 You're viewing this 1 SYRINGE, GLASS in 1 CARTON / .7 mL in 1 SYRINGE, GLASS 2025-06-09 — Active
00006-5073-02 0006-5073-02 Main listing 10 SYRINGE, GLASS in 1 CARTON / .7 mL in 1 SYRINGE, GLASS 2025-06-09 — Active

This pack accounts for about 11% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 1 syringe — 1 syringe, glass in 1 carton / .7 ml in 1 syringe, glass.
How does this package differ from NDC 00006-5073-02?
Both are ENFLONSIA CLESROVIMAB 150 mg/mL Injection, Solution — the drug itself is identical. This page's package is the 1 syringe one, while NDC 00006-5073-02 is the 10 syringes package.
What NDC number is used to bill for this package of ENFLONSIA CLESROVIMAB 150 mg/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Enflonsia 150 mg/mLthis 00006-5073-01 Merck 1 syringe — — 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

🏛️
2025
First FDA approval
Jun 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2037
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 Jun 2037. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 9, 2025 ⏳ ~10.7 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
Enflonsiaclesrovimab-cfor
🔒 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
2025 2027 2029 2031 2033 2035 2037
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 dateJun 9, 2037
Common questions
Is there a biosimilar for ENFLONSIA 105 MG/0.7 ML SYRNG?
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 White
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.

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

  • UNII F7LTH1E20Y
    Arginine hydrochloride is an amino acid salt used as a buffer and pH adjuster in medicines. It helps maintain the correct acidity level to keep the drug stable and effective.
  • UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • UNII X573657P6P
    Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
  • 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.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.

6 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 applicationBLA761432 (BLA)
Labeler code00006
First marketedJun 2025
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 🆘 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 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 71 words ▾

1 INDICATIONS AND USAGE ENFLONSIA is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. ENFLONSIA is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended dosage: 105 mg administered as a single intramuscular (IM) injection. ( 2.1 )

2.1Recommended Dosage The recommended dose for neonates and infants born during or entering their first RSV season is 105 mg administered as a single intramuscular (IM) injection. For neonates and infants born during the RSV season, administer ENFLONSIA once starting from birth. For infants born outside the RSV season, administer ENFLONSIA once prior to the start of their first RSV season considering the duration of protection provided by ENFLONSIA [see Clinical Pharmacology (12.2) ].

Infants Undergoing Cardiac Surgery with Cardiopulmonary Bypass For infants undergoing cardiac surgery with cardiopulmonary bypass during or entering their first RSV season, an additional 105 mg dose administered as an IM injection is recommended as soon as the infant is stable after surgery to ensure adequate clesrovimab-cfor serum levels.

2.2Administration Instructions ENFLONSIA must be administered by a healthcare provider. Before injection, remove ENFLONSIA from the refrigerator and allow the prefilled syringe to come to room temperature for approximately 15 minutes. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

ENFLONSIA is a clear to slightly opalescent, colorless to slightly yellow solution. This product should not be used if particulate matter or discoloration is found. Do not use if the prefilled syringe has been dropped or damaged, the security seal on the carton has been broken, or the expiration date has passed.

Refer to Figure 1 for prefilled syringe components. Figure 1: Prefilled Syringe Components Step 1: Hold the syringe barrel in one hand and unscrew the tip cap by twisting it counter-clockwise with the other hand. Do not remove the Luer Lock adaptor and the finger flange extender.

Step 2: Attach a sterile Luer Lock needle by twisting in a clockwise direction until the needle fits securely on the syringe. Due to the viscosity of the product, use a 22- to 25-gauge needle. Step 3: Inject the entire contents of the ENFLONSIA prefilled syringe intramuscularly in the anterolateral aspect of the thigh.

ENFLONSIA should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel. Step 4: Discard syringe into a sharps container. Co-administration with Childhood Vaccines and Immunoglobulin Products ENFLONSIA can be given concomitantly with childhood vaccines [see Clinical Pharmacology (12.3) ] .

When ENFLONSIA is administered concomitantly with injectable vaccines, it should be given using a separate syringe and at a different injection site. Do not mix ENFLONSIA with any vaccines or medications in the same syringe or vial. There is no information regarding co-administration of ENFLONSIA with other immunoglobulin products.

There are no data regarding substitution of ENFLONSIA for palivizumab once prophylaxis treatment is initiated with palivizumab for the RSV season. Prefilled Syringe

💊 Dosage Forms and Strengths 35 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 105 mg/0.7 mL clear to slightly opalescent, colorless to slightly yellow solution in a single-dose prefilled syringe. Injection: 105 mg/0.7 mL in a single-dose prefilled syringe. ( 3 )

⛔ Contraindications 52 words ▾

4 CONTRAINDICATIONS ENFLONSIA is contraindicated in infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA [see Warnings and Precautions (5.1) and Description (11) ]. ENFLONSIA is contraindicated in infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA. ( 4 )

⚠️ Warnings and Cautions 130 words ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Including Anaphylaxis: Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human immunoglobulin G1 (IgG1) monoclonal antibodies. Initiate appropriate medications and/or supportive care if such reactions occur. ( 5.1 )

5.1Hypersensitivity Including Anaphylaxis Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, initiate appropriate medications and/or supportive therapy.

5.2RSV Diagnostic Test Interference Clesrovimab-cfor may interfere with some immunologically-based RSV diagnostic assays (i.e., rapid antigen tests) as observed in laboratory studies. Confirmation using a reverse transcriptase polymerase chain reaction (RT-PCR) assay is recommended when rapid antigen assay results are negative and clinical observations are consistent with RSV infection [see Drug Interactions (7.1) ].

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions were injection-site erythema (3.8%), injection-site swelling (2.7%) and rash (2.3%). ( 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. The safety of ENFLONSIA was evaluated in 2,858 infants who received ENFLONSIA in Phase 2b/3 and Phase 3 clinical trials (Trial 004 and Trial 007). Neonates and Infants Entering Their First RSV Season (Trial 004) Trial 004 was a Phase 2b/3, randomized, double-blind placebo-controlled, multisite trial conducted in early and moderate preterm infants (≥29 to <35 weeks gestational age (GA)) and late preterm and full-term infants (≥35 weeks GA).

Participants were randomized 2:1 and received a single 105 mg dose of ENFLONSIA (N=2,412, including 422 early and moderate preterm infants) or saline placebo (N=1,202, including 209 early and moderate preterm infants) by IM injection. Participants were monitored for 30 minutes post-dose. Safety was assessed using an electronic diary device from Days 1 through 42 post-dose.

Participants were monitored for serious adverse events (SAEs) through the duration of their participation for up to 365 days post-dose. A subset of participants was monitored for SAEs for up to 515 days post-dose. Table 1 summarizes the adverse reactions in participants who received ENFLONSIA.

Most (≥97%) of the adverse reactions were toxicity grade 1 (mild) or grade 2 (moderate). Table 1: Adverse Reactions Reported at an Incidence Higher Than Placebo (Trial 004) Adverse Reaction ENFLONSIA N=2,412 Sample size reflects the number of participants included in the safety analysis population. % Placebo N=1,202 % Injection-site erythema Solicited on Day 1 through Day 5 post-dose using an electronic diary device. (occurring within 5 days post-dose) 3.8

3.3Injection-site swelling (occurring within 5 days post-dose) 2.7

2.6Rash Defined by the following grouped preferred terms: rash, rash erythematous, rash macular, rash papular, rash maculo-papular, rash vesicular, rash exfoliative, dermatitis allergic, drug eruption and toxic skin eruption. (occurring within 14 days post-dose) 2.3

1.9Infants Born at ≤35 Weeks Gestational Age and Infants with Chronic Lung Disease (CLD) of Prematurity or Hemodynamically Significant Congenital Heart Disease (CHD) Entering Their First RSV Season (Trial 007) Trial 007 was a Phase 3, randomized, partially-blind, palivizumab-controlled, multisite trial conducted in infants at increased risk of severe RSV disease. Participants were randomized and received a single 105 mg dose of ENFLONSIA (N=446) followed by a dose of placebo one month later or 3 to 5 monthly doses of 15 mg/kg palivizumab (N=450) by IM injection.

Of the 446 participants who received ENFLONSIA, 176 had CLD of prematurity or CHD and 270 were early or moderate preterm infants (≤35 weeks GA) without CLD of prematurity or CHD. Participants were monitored for 30 minutes post-dose. Safety was assessed using an electronic diary device from Day 1 (dose 1) through 14 days post-dose 2, and 14 days after each subsequent dose.

Participants were monitored for serious adverse events in the first RSV season for up to 365 days. The safety profile of ENFLONSIA in infants at increased risk of severe RSV disease entering their first season was similar to palivizumab and consistent with the safety profile of ENFLONSIA in infants in Trial 004.

🔄 Drug Interactions 69 words ▾

7 DRUG INTERACTIONS

7.1Interference with Rapid Antigen Detection RSV Diagnostic Assays Clesrovimab-cfor may interfere with some immunologically-based RSV diagnostic assays (i.e., rapid antigen tests) as observed in laboratory studies. Confirmation using an RT-PCR assay is recommended when rapid antigen RSV diagnostic assay results are negative and clinical observations are consistent with RSV infection. Clesrovimab-cfor does not interfere with RT-PCR diagnostic assays [see Warnings and Precautions (5.2) ] .

👥 Use in Specific Populations 114 words ▾

8 USE IN SPECIFIC POPULATIONS The safety and effectiveness of ENFLONSIA have not been established in children older than 12 months of age. ( 8.4 )

8.1Pregnancy ENFLONSIA is not indicated for use in females of reproductive potential.

8.2Lactation ENFLONSIA is not indicated for use in females of reproductive potential.

8.4Pediatric Use The safety and effectiveness of ENFLONSIA have been established for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and the information on this use is discussed throughout the labeling. The safety and effectiveness of ENFLONSIA have not been established in children older than 12 months of age.

🤰 Pregnancy 13 words ▾

8.1Pregnancy ENFLONSIA is not indicated for use in females of reproductive potential.

🧒 Pediatric Use 62 words ▾

8.4Pediatric Use The safety and effectiveness of ENFLONSIA have been established for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and the information on this use is discussed throughout the labeling. The safety and effectiveness of ENFLONSIA have not been established in children older than 12 months of age.

🆘 Overdosage 44 words ▾

10 OVERDOSAGE There is limited experience of overdose with ENFLONSIA. There is no specific treatment for an overdose with ENFLONSIA. In the event of an overdose, the infant should be monitored for the occurrence of adverse reactions and provided with symptomatic treatment as appropriate.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action ENFLONSIA is a monoclonal antibody with anti-RSV activity [see Microbiology (12.4) ].

12.2Pharmacodynamics RSV serum neutralizing antibody titer correlates with clesrovimab-cfor serum concentration. Following IM administration of clesrovimab-cfor in infants, the RSV neutralizing antibody titers in serum were estimated to be approximately 7 times higher than baseline at 4 hours after clesrovimab-cfor dosing and maximum titers were reached by day 7, for a typical infant weighing 5 kg. Exposure-Response Relationship In the Phase 2b/3 trial evaluating the recommended dose of clesrovimab-cfor (a single dose of 105 mg) in healthy preterm and full-term infants (Trial 004), no significant relationship was observed between AUC (from day 1 to day 150) and clinical outcomes (e.g., RSV-associated Medically Attended Lower Respiratory Infection (MALRI)).

Duration of Protection Based on clinical trial data, the duration of protection demonstrated by a single dose of ENFLONSIA extends through 5 months [see Clinical Studies (14.2) ].

12.3Pharmacokinetics The PK of clesrovimab-cfor is approximately dose-proportional following a single IM administration of doses ranging from 20 mg to 210 mg in infants. Following IM administration of the 105 mg recommended dose, the geometric mean (% geometric CV) area under the time concentration curve from day 1 to day 150 (AUC 0-150 ) is 6,470 mcg×d/mL (22.6%), peak concentration (C max ) is 120 mcg/mL (25.4%), and the concentration at day 150 (C 150 ) is 10.3 mcg/mL (36.6%). In the first RSV season, the clesrovimab-cfor serum exposures were similar in neonates and infants in Trial 004, in preterm neonates and infants born at less than or equal to 35 weeks GA (including less than 29 weeks GA) in Trial 007, and in neonates and infants with CLD or CHD in Trial 007.

Absorption The median time to maximum concentration is 6.5 days (5.9, 7.4 which are the 2.5 and 97.5 percentiles, respectively). Distribution The estimated apparent volume of distribution for clesrovimab-cfor is 830 mL, for a typical infant weighing 5 kg. Elimination The clesrovimab-cfor terminal half-life is approximately 44.0 days and the estimated apparent clearance is 19.7 mL/day for a typical infant weighing 5 kg.

Metabolism Clesrovimab-cfor is degraded into small peptides by catabolic pathways. Specific Populations No clinically significant differences in the pharmacokinetics of clesrovimab-cfor were observed based on race or vulnerability to severe RSV disease (i.e., CLD, CHD, or GA <29 weeks). An effect of renal or hepatic impairment on clesrovimab-cfor pharmacokinetics is not expected.

Drug Interaction Studies Since clesrovimab-cfor is eliminated by catabolism, no metabolic drug-drug interactions are expected. However, no formal drug interaction studies have been performed with ENFLONSIA. Clinical Studies Vaccines : In clinical trials, when ENFLONSIA was given concomitantly with routine childhood vaccines, the safety profile of the co-administered regimen was generally comparable to the safety profile when ENFLONSIA and childhood vaccines were administered alone.

12.4Microbiology Mechanism of Action Clesrovimab-cfor is a recombinant human immunoglobulin G1 kappa (IgG1κ) neutralizing monoclonal antibody with a YTE triple amino acid substitution (M252Y/S254T/T256E) in the Fc region which increases binding to the neonatal Fc receptor leading to an extended serum half-life. Passive immunity is provided by clesrovimab-cfor, which targets the extracellular domain of the RSV fusion (F) protein to prevent fusion of the viral and cellular membranes and viral entry. Clesrovimab-cfor binds to a conserved epitope on antigenic site IV on the F protein and binds to RSV A pre-fusion F glycoprotein and post-fusion F glycoprotein with equilibrium dissociation constant values (K D ) of 71 pM and 480 pM, respectively.

Antiviral Activity A neutralization assay in Hep-2 cells was used to determine clesrovimab-c… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 16 words ▾

12.1Mechanism of Action ENFLONSIA is a monoclonal antibody with anti-RSV activity [see Microbiology (12.4) ].

📦 How Supplied / Storage and Handling 144 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ENFLONSIA injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution supplied as follows: Carton containing one or ten single-dose prefilled type I glass syringe(s) with Luer Lock and plunger stopper. The prefilled syringe is not made with natural rubber latex. Prefilled syringe Pack Size NDC 105 mg/0.7 mL single-dose Carton of 1 0006-5073-01 105 mg/0.7 mL single-dose Carton of 10 0006-5073-02 Storage and Handling Store prefilled syringes under refrigeration at 36°F to 46°F (2°C to 8°C).

Keep the prefilled syringe in the original carton to protect from light until time of use. ENFLONSIA may be kept at room temperature between 68°F to 77°F (20°C to 25°C) for a maximum of 48 hours. After removal from the refrigerator, ENFLONSIA must be used within 48 hours or discarded.

Do not freeze. Do not shake.

📦 Storage and Handling 71 words ▾

Storage and Handling Store prefilled syringes under refrigeration at 36°F to 46°F (2°C to 8°C). Keep the prefilled syringe in the original carton to protect from light until time of use. ENFLONSIA may be kept at room temperature between 68°F to 77°F (20°C to 25°C) for a maximum of 48 hours. After removal from the refrigerator, ENFLONSIA must be used within 48 hours or discarded. Do not freeze. Do not shake.

📋 Description 93 words ▾

11 DESCRIPTION Clesrovimab-cfor is a respiratory syncytial virus F protein-directed fusion inhibitor. Clesrovimab-cfor is a fully human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in recombinant Chinese hamster ovary (CHO) cells. The molecular weight is approximately 149 kDa.

ENFLONSIA (clesrovimab-cfor) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intramuscular injection. Each 0.7 mL contains 105 mg of clesrovimab-cfor, arginine hydrochloride (10.33 mg), histidine (0.55 mg), L-histidine monohydrochloride monohydrate (0.74 mg), polysorbate 80 (0.14 mg), sucrose (35 mg) and water for injection (USP). The pH is 6.0.

💬 Information for Patients 84 words ▾

17 PATIENT COUNSELING INFORMATION Advise the child’s caregiver to read the FDA-approved patient labeling ( Patient Information ). Hypersensitivity Reactions Including Anaphylaxis Inform the patient’s caregiver of the signs and symptoms of potential hypersensitivity reactions, and advise the caregiver to seek medical attention immediately if the infant experiences a hypersensitivity reaction to ENFLONSIA [see Warnings and Precautions (5.1) ]. Dosage and Administration Advise the caregiver that the infant will receive ENFLONSIA by IM injection by a healthcare provider [see Dosage and Administration (2.1) ].

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics The PK of clesrovimab-cfor is approximately dose-proportional following a single IM administration of doses ranging from 20 mg to 210 mg in infants. Following IM administration of the 105 mg recommended dose, the geometric mean (% geometric CV) area under the time concentration curve from day 1 to day 150 (AUC 0-150 ) is 6,470 mcg×d/mL (22.6%), peak concentration (C max ) is 120 mcg/mL (25.4%), and the concentration at day 150 (C 150 ) is 10.3 mcg/mL (36.6%). In the first RSV season, the clesrovimab-cfor serum exposures were similar in neonates and infants in Trial 004, in preterm neonates and infants born at less than or equal to 35 weeks GA (including less than 29 weeks GA) in Trial 007, and in neonates and infants with CLD or CHD in Trial 007.

Absorption The median time to maximum concentration is 6.5 days (5.9, 7.4 which are the 2.5 and 97.5 percentiles, respectively). Distribution The estimated apparent volume of distribution for clesrovimab-cfor is 830 mL, for a typical infant weighing 5 kg. Elimination The clesrovimab-cfor terminal half-life is approximately 44.0 days and the estimated apparent clearance is 19.7 mL/day for a typical infant weighing 5 kg.

Metabolism Clesrovimab-cfor is degraded into small peptides by catabolic pathways. Specific Populations No clinically significant differences in the pharmacokinetics of clesrovimab-cfor were observed based on race or vulnerability to severe RSV disease (i.e., CLD, CHD, or GA <29 weeks). An effect of renal or hepatic impairment on clesrovimab-cfor pharmacokinetics is not expected.

Drug Interaction Studies Since clesrovimab-cfor is eliminated by catabolism, no metabolic drug-drug interactions are expected. However, no formal drug interaction studies have been performed with ENFLONSIA. Clinical Studies Vaccines : In clinical trials, when ENFLONSIA was given concomitantly with routine childhood vaccines, the safety profile of the co-administered regimen was generally comparable to the safety profile when ENFLONSIA and childhood vaccines were administered alone.

🧬 Pharmacodynamics 136 words ▾

12.2Pharmacodynamics RSV serum neutralizing antibody titer correlates with clesrovimab-cfor serum concentration. Following IM administration of clesrovimab-cfor in infants, the RSV neutralizing antibody titers in serum were estimated to be approximately 7 times higher than baseline at 4 hours after clesrovimab-cfor dosing and maximum titers were reached by day 7, for a typical infant weighing 5 kg. Exposure-Response Relationship In the Phase 2b/3 trial evaluating the recommended dose of clesrovimab-cfor (a single dose of 105 mg) in healthy preterm and full-term infants (Trial 004), no significant relationship was observed between AUC (from day 1 to day 150) and clinical outcomes (e.g., RSV-associated Medically Attended Lower Respiratory Infection (MALRI)).

Duration of Protection Based on clinical trial data, the duration of protection demonstrated by a single dose of ENFLONSIA extends through 5 months [see Clinical Studies (14.2) ].

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Description of Clinical Trials The efficacy and safety of ENFLONSIA were evaluated in preterm and full-term infants in the trials summarized in Table 2. Table 2: Trials Conducted with ENFLONSIA for the Prevention of Medically Attended RSV Lower Respiratory Tract Disease Trial Study Population Study Arms Participants randomized and treated GA=gestational age; CLD=chronic lung disease; CHD=hemodynamically significant congenital heart disease Trial 004 (NCT04767373) Infants born at ≥29 weeks GA from birth up to 1 year entering their first RSV season.

ENFLONSIA (N=2,411) Placebo (N=1,203) 1 participant was randomized to placebo but received ENFLONSIA Trial 007 (NCT04938830) Infants born at ≤35 weeks GA, or infants with CLD of prematurity or hemodynamically significant CHD from birth up to 1 year entering their first RSV season. ENFLONSIA (N=446) Palivizumab (N=450)

14.2Prevention of RSV-Associated Disease in Neonates and Infants (≥29 Weeks GA) Entering Their First RSV Season (Trial 004) Trial 004 was a Phase 2b/3, randomized, double-blind placebo-controlled, multi-site trial conducted in 22 countries from the Northern and Southern Hemispheres to evaluate the efficacy of ENFLONSIA in early and moderate preterm infants (≥29 to <35 weeks GA) and late preterm and full-term infants (≥35 weeks GA). The trial assessed the efficacy of ENFLONSIA in the prevention of RSV-associated disease across a spectrum of severity.

Participants were randomized 2:1 to receive a single 105 mg dose of ENFLONSIA or saline placebo by IM injection. Among participants who received ENFLONSIA or saline placebo, the median age of infants was 3.1 months (range: 0 to 12 months); 80% were less than 6 months; 16% were greater than or equal to 6 to less than 9 months, 4% were greater than or equal to 9 months of age, and 51% were male. Of these participants, 18% were GA greater than or equal to 29 weeks and less than 35 weeks, and 82% were GA greater than or equal to 35 weeks.

The racial distribution was as follows: 45% were White; 27% were Asian; 14% were Black or African American; 12% were Multi-racial and 2% were American Indian or Alaska Native; 28% were of Hispanic or Latino ethnicity. The primary endpoint was the incidence of RSV-associated Medically Attended Lower Respiratory Infection (MALRI) characterized as cough or difficulty breathing and requiring ≥1 indicator of LRI (wheezing, rales/crackles) or severity (chest wall in-drawing/retractions, hypoxemia, tachypnea, dehydration due to respiratory symptoms) through 150 days after dosing.

Medically Attended (MA) includes all healthcare provider visits in settings such as outpatient clinic, clinical study site, emergency department, urgent care center, and/or hospital. The statistical criterion for success required the lower bound of the 95% CI of efficacy to be greater than 25%. RSV-associated hospitalization through 150 days after dosing was evaluated as a key secondary endpoint.

The statistical criterion for success required the lower bound of the 95% CI of efficacy to be greater than 0%. Both efficacy endpoints required an RSV-positive RT-PCR nasopharyngeal (NP) sample. Table 3 displays efficacy results for the primary and key secondary RSV-associated disease endpoints in preterm and full-term infants from days 1 through 150 post-dose.

Table 3: Incidence of RSV-Associated Disease in Infants Born at ≥29 Weeks GA Days 1 Through 150 Post-Dose (Trial 004) RSV-Associated Endpoint ENFLONSIA (n=2,411) Placebo (n=1,203) Efficacy Efficacy for MALRI (requiring ≥1 indicator of LRI or severity) and hospitalization based on relative risk reduction against placebo adjusted for hemisphere at randomization, gestational age group and age group at randomization. (95% CI) Estimate and 95% CI of efficacy were estimated from the modified Poisson regression with robust variance method.

Number of cases Incidence Rate over 5 months Number of cases Incidence Rate over 5 months n=Number of participants elig… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 21 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis, mutagenesis and reproductive toxicity studies have not been performed with ENFLONSIA.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 18 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis, mutagenesis and reproductive toxicity studies have not been performed with ENFLONSIA.

📄 Patient Package Insert ~2 min read ▾

Patient Information ENFLONSIA ™ (en-flahn-see-ah) (clesrovimab-cfor) injection, for intramuscular use This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 06/2025 What is ENFLONSIA? ENFLONSIA is a prescription medicine to help prevent lung disease, including severe lung disease, caused by Respiratory Syncytial Virus (RSV) in newborns and babies who are born during or entering their first RSV season.

ENFLONSIA contains antibodies to help prevent RSV disease. It is not known if ENFLONSIA is safe and effective in children older than 12 months of age. Your child should not receive ENFLONSIA if your child has a history of serious allergic reactions to any of the ingredients in ENFLONSIA.

See the end of this Patient Information leaflet for a complete list of ingredients in ENFLONSIA. Before your child receives ENFLONSIA, tell their healthcare provider about all of your child’s medical conditions, including if your child: is scheduled to have heart surgery during or entering their first RSV season. Tell your child’s healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How is ENFLONSIA given? ENFLONSIA is given as an injection, in the thigh muscle, by your child’s healthcare provider. Your child should get ENFLONSIA before the start of or during the RSV season.

RSV season is the time of year when RSV infections are most common, usually occurring fall through spring. Your child’s healthcare provider can tell you when the RSV season starts in your area. Your child may still get RSV disease after receiving ENFLONSIA.

Talk to your child’s healthcare provider about what symptoms to look for. If your child has heart surgery, your child’s healthcare provider may need to give your child an additional ENFLONSIA injection soon after surgery. Your child can get ENFLONSIA at the same time as routine childhood vaccines.

What are the possible side effects of ENFLONSIA? Serious allergic reactions have happened with other medicines like ENFLONSIA. Get medical help right away if your child has any of the following signs or symptoms of a serious allergic reaction, including: swelling of the face, mouth, or tongue difficulty swallowing or breathing unresponsiveness bluish color of skin, lips or under fingernails muscle weakness severe rash, hives or itching The most common side effects of ENFLONSIA are: redness and swelling at the site of your child’s injection rash These are not all the possible side effects of ENFLONSIA.

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 ENFLONSIA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or child’s healthcare provider for information about ENFLONSIA that is written for health professionals. What are the ingredients in ENFLONSIA?

Active ingredient: clesrovimab-cfor Inactive ingredients: arginine hydrochloride, histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose and water for injection. Manufactured by: Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA. U.S.

License No. 0002 For patent information: www.msd.com/research/patent . Copyright © 2025 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates.

All rights reserved. usppi-mk1654-i-2506r000 For more information, go to www.ENFLONSIA.com or call 1-877-888-4231.

📄 Package Label / Principal Display Panel 161 words ▾

PRINCIPAL DISPLAY PANEL - 1 Single-Dose Syringe Carton NDC 0006-5073-01 One 105 mg/0.7 mL single-dose prefilled syringe ENFLONSIA™ (clesrovimab-cfor) Injection 105 mg / 0.7 mL For Intramuscular Use Only This package does not contain a needle. Must be administered by a healthcare provider. REFRIGERATE Rx Only PRINCIPAL DISPLAY PANEL - 1 Single-Dose Syringe Carton

PRINCIPAL DISPLAY PANEL - 10 Single-Dose Syringe Carton NDC 0006-5073-02 Ten 105 mg/0.7 mL single-dose prefilled syringes ENFLONSIA™ (clesrovimab-cfor) Injection 105 mg / 0.7 mL For Intramuscular Use Only This package does not contain needles. Must be administered by a healthcare provider. REFRIGERATE Rx only PRINCIPAL DISPLAY PANEL - 10 Single-Dose Syringe Carton

PRINCIPAL DISPLAY PANEL - 0.7 mL Syringe Label NDC 0006-5073-99 One 105 mg/0.7 mL single-dose prefilled syringe ENFLONSIA™ (clesrovimab-cfor) Injection 105 mg / 0.7 mL For Intramuscular Use Only Rx only Store at 2°C-8°C (36°F-46°F). Manuf. by: Merck Sharp & Dohme LLC U.S. License No. 0002 PRINCIPAL DISPLAY PANEL - 0.7 mL Syringe Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q4 2025 – Q1 2026 · 2 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
29
Units reimbursed last 4 qtrs
11
Gross reimbursed last 4 qtrs
$667.20
Avg / prescription
$23.01
Avg / unit
$60.1623
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 29 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 11 units · 0.2 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.20.2
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Indiana 0.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
10 syringes00006-5073-02 247 Rx · $931
1 syringe this page00006-5073-01 29 Rx · $667
Drug total (last 4 qtrs): 276 Rx · 53 units · $1,598 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Merck Sharp & Dohme LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 10 syringes (00006-5073-02). Each has its own NDC and its own page — see the package list near the top of this page.
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.
← 00006-5055-06 · Merck 00006-5083-01 · 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.