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Synagis palivizumab 100 mg/mL Injection, Solution, 1 mL — NDC 66658-231-01 (Billing 66658-0231-01)

by Swedish Orphan Biovitrum AB (publ) · 1 mL in 1 VIAL, SINGLE-DOSE

This is a package of 1 mL of Synagis palivizumab 100 mg/mL Injection, Solution from Swedish Orphan Biovitrum AB (publ), no longer marketed (first marketed Jun 1998), no longer in the FDA NDC Directory, this package's marketing ended Jul 2026. It is this product's only package size.

NDC 66658-0231-01
🏷️ FDA NDC (as labeled) 66658-231-01 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 →

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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 66658-231-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
66658 labeler · 231 product · 01 package
Package marketed since
Sep 28, 2005
Package marketing ended
Jul 31, 2026
Sample package
No — commercial package
Billing quantity
1 mL per package
Barcode (UPC)
0366658231013
Medicaid fills, this package
180 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 66658-231-01
Product NDC 66658-231
11-digit billing NDC 66658023101
NCPDP billing unit ML — per mL (volume)
RxCUI 1657341, 1657343, 1657361, 1657362
UNII DQ448MW7KS
UPC 0366658231013
Application # BLA103770
SPL Set ID 3a0096c7-8139-44cd-bba4-520ab05c2cb2
Established class (EPC) Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody
Mechanism of action Fusion Protein Inhibitors
Chemical class Antibodies, Monoclonal
DEA schedule Non-controlled
Marketing category BLA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2026)
Marketing start 1998-06-19
Marketing end 2026-07-31
Route INTRAMUSCULAR
Dosage form INJECTION, SOLUTION
Substance PALIVIZUMAB
Biologic (Purple Book) 351(a)

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

GPI-14 19502060002020
GPI class Synagis
GCN Seq No 059246
GCN 24824
HICL code 018564
Ingredient (HICL) Palivizumab
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 SYNAGIS 100 MG/ML VIAL
FDB brand name Synagis
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 059246
  • GCN: 24824
  • GPI-14 (Medi-Span): 19502060002020
  • HICL (First Databank): 018564
  • AHFS class code: 08:18.24.00
  • RxCUI (RxNorm): 1657341
Why two NDCs? The FDA registers this code as 66658-231-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 66658-0231-01. 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 Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody class.

Pharmacologic class Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody
Drug family (ATC) Antiviral monoclonal antibodies
How it works Fusion Protein Inhibitors
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 SYNAGIS 100 MG/ML VIAL Ingredient Palivizumab
📖 What it is MedlinePlus · NLM

Palivizumab injection is used to help prevent respiratory syncytial virus (RSV; common virus that can cause serious lung infections) in children less than 24 months old who are at high risk for getting RSV. Children at high risk for RSV include those who were born prematurely or have certain heart or lung diseases. Palivizumab injection is not used to treat the symptoms of RSV disease once a child already has it. Palivizumab injection is in a class of medications called monoclonal antibodies. It works by helping the immune system to slow or stop the spread of the virus in the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It helps prevent serious RSV lung infections in certain high-risk children. These include babies born early, children with bronchopulmonary dysplasia, and children with significant...
  • It is a shot into the thigh muscle given once a month during RSV season. The first dose comes before the season starts. Keep the monthly schedule even if your child catches RSV.
  • The most common ones are fever and rash. Injection site reactions can also happen. These are usually the things to mention at the next visit.
  • Severe allergic reactions are rare but serious. Get emergency help for hives, swelling, trouble breathing, bluish skin, limpness, or unresponsiveness. Also tell the doctor about un...
📖 Read our full Palivizumab Injection guide →
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 $3,329.57 $3,329.57 / 1 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
66658-0231-01 You're viewing this Main listing 1 mL in 1 VIAL, SINGLE-DOSE 2005-09-28 Jul 31, 2026 Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Synagis 100 mg/mLthis 66658-0231-01 Swedish 1 ml — — Discontinued —
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

🏛️
1998
First FDA approval
Jun 1998
📍
2026
Currently FDA-listed
28 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

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

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Synagispalivizumab
🔒 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.
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.

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 Palivizumab 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.

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerSwedish Orphan Biovitrum AB (publ)
FDA applicationBLA103770 (BLA)
Labeler code66658
First marketedJun 1998
Product typeHuman Prescription Drug
Portfolio16 products on file

More NDCs from Swedish Orphan Biovitrum AB (publ) labeler code 66658

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 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients: with a history of premature birth (less than or equal to 35 weeks gestational age) and who are 6 months of age or younger at the beginning of RSV season, with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season, with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season [see Clinical Studies ( 14 ) ].

Synagis is a respiratory syncytial virus (RSV) F protein inhibitor monoclonal antibody indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients: with a history of premature birth (less than or equal to 35 weeks gestational age) and who are 6 months of age or younger at the beginning of RSV season, with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season, with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season.

Limitations of Use: The safety and efficacy of Synagis have not been established for treatment of RSV disease. ( 1 ) Limitations of Use: The safety and efficacy of Synagis have not been established for treatment of RSV disease [see Warnings and Precautions ( 5.4 )] .

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION 15 mg per kg of body weight, administered intramuscularly prior to commencement of the RSV season and remaining doses administered monthly throughout the RSV season. ( 2.1 ) Children undergoing cardio-pulmonary bypass should receive an additional dose of Synagis as soon as possible after the cardio-pulmonary bypass procedure (even if sooner than a month from the previous dose). Thereafter, doses should be administered monthly as scheduled.

( 2.1 , 12.3 )

2.1Dosing Information The recommended dose of Synagis is 15 mg per kg of body weight given monthly by intramuscular injection. The first dose of Synagis should be administered prior to commencement of the RSV season and the remaining doses should be administered monthly throughout the RSV season. Children who develop an RSV infection should continue to receive monthly doses throughout the RSV season.

In the northern hemisphere, the RSV season typically commences in November and lasts through April, but it may begin earlier or persist later in certain communities. Synagis serum levels are decreased after cardio-pulmonary bypass [see Clinical Pharmacology ( 12.3 ) ]. Children undergoing cardio-pulmonary bypass should receive an additional dose of Synagis as soon as possible after the cardio-pulmonary bypass procedure (even if sooner than a month from the previous dose).

Thereafter, doses should be administered monthly as scheduled. The efficacy of Synagis at doses less than 15 mg per kg, or of dosing less frequently than monthly throughout the RSV season, has not been established.

2.2Administration Instructions DO NOT DILUTE THE PRODUCT. DO NOT SHAKE OR VIGOROUSLY AGITATE THE VIAL. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Do not use any vials exhibiting particulate matter or discoloration. Using aseptic techniques, attach a sterile needle to a sterile syringe. Remove the flip top from the Synagis vial and wipe the rubber stopper with a disinfectant (e.g., 70% isopropyl alcohol).

Insert the needle into the vial and withdraw into the syringe an appropriate volume of solution. Administer immediately after drawing the dose into the syringe. Synagis should be administered in a dose of 15 mg per kg intramuscularly using aseptic technique, preferably in the anterolateral aspect of the thigh.

The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. The dose (volume of injection in mL) per month = patient weight (kg) x 15 mg per kg ÷ 100 mg per mL of Synagis. Injection volumes over 1 mL should be given as a divided dose.

Synagis is supplied as a single-dose vial and does not contain preservatives. Do not re-enter the vial after withdrawal of drug; discard unused portion. Only administer one dose per vial.

Use sterile disposable syringes and needles. To prevent the transmission of hepatitis viruses or other infectious agents from one person to another, DO NOT reuse syringes and needles.

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS Single-dose liquid solution vials: 50 mg per 0.5 mL and 100 mg per 1 mL. Single-dose liquid solution vials: 50 mg per 0.5 mL and 100 mg per 1 mL. ( 3 )

⛔ Contraindications 34 words ▾

4 CONTRAINDICATIONS Synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to Synagis [see Warnings and Precautions ( 5.1 ) ]. Previous significant hypersensitivity reaction to Synagis. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Anaphylaxis and anaphylactic shock (including fatal cases), and other severe acute hypersensitivity reactions have been reported. Permanently discontinue Synagis and administer appropriate medications if such reactions occur. ( 5.1 ) As with any intramuscular injection, Synagis should be given with caution to children with thrombocytopenia or any coagulation disorder.

( 5.2 ) Palivizumab may interfere with immunological-based RSV diagnostic tests such as some antigen detection-based assays. ( 5.3 , 12.4 )

5.1Hypersensitivity Reactions Cases of anaphylaxis and anaphylactic shock, including fatal cases, have been reported following initial exposure or re-exposure to Synagis. Other acute hypersensitivity reactions, which may be severe, have also been reported on initial exposure or re-exposure to Synagis. Signs and symptoms may include urticaria, pruritus, angioedema, dyspnea, respiratory failure, cyanosis, hypotonia, hypotension, and unresponsiveness.

The relationship between these reactions and the development of antibodies to Synagis is unknown. If a significant hypersensitivity reaction occurs with Synagis, its use should be permanently discontinued. If anaphylaxis or other significant hypersensitivity reaction occurs, administer appropriate medications (e.g., epinephrine) and provide supportive care as required.

If a mild hypersensitivity reaction occurs, clinical judgment should be used regarding cautious readministration of Synagis.

5.2Coagulation Disorders Synagis is for intramuscular use only. As with any intramuscular injection, Synagis should be given with caution to children with thrombocytopenia or any coagulation disorder.

5.3RSV Diagnostic Test Interference Palivizumab may interfere with immunological-based RSV diagnostic tests such as some antigen detection-based assays. In addition, palivizumab inhibits virus replication in cell culture, and therefore may also interfere with viral culture assays. Palivizumab does not interfere with reverse transcriptase-polymerase chain reaction based assays.

Assay interference could lead to false-negative RSV diagnostic test results. Therefore, diagnostic test results, when obtained, should be used in conjunction with clinical findings to guide medical decisions [see Microbiology ( 12.4 ) ].

5.4Treatment of RSV Disease The safety and efficacy of Synagis have not been established for treatment of RSV disease.

5.5Proper Administration The single-dose vial of Synagis does not contain a preservative. Administration of Synagis should occur immediately after dose withdrawal from the vial. The vial should not be re-entered. Discard any unused portion.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most serious adverse reactions occurring with Synagis are anaphylaxis and other acute hypersensitivity reactions [see Warnings and Precautions ( 5.1 ) ]. Adverse reactions occurring greater than or equal to 10% and at least 1% more frequently than placebo are fever and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact 1-866-773-5274 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Studies 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 data described below reflect exposure to Synagis (n=1639) compared with placebo (n=1143) in children 3 days to 24.1 months of age at high risk of RSV-related hospitalization in two clinical trials. Trial 1 was conducted during a single RSV season and studied a total of 1502 children less than or equal to 24 months of age with BPD or infants with premature birth (less than or equal to 35 weeks gestation) who were less than or equal to 6 months of age at study entry.

Trial 2 was conducted over four consecutive seasons among a total of 1287 children less than or equal to 24 months of age with hemodynamically significant congenital heart disease. In Trials 1 and 2 combined, fever and rash were each reported more frequently among Synagis than placebo recipients, 27% versus 25%, and 12% versus 10%, respectively. Adverse reactions observed in the 153-patient crossover study comparing the liquid and lyophilized formulations were comparable for the two formulations, and were similar to those observed with Synagis in Trials 1 and 2.

Immunogenicity In Trial 1, the incidence of anti-palivizumab antibody following the fourth injection was 1.1% in the placebo group and 0.7% in the Synagis group. In children receiving Synagis for a second season, one of the fifty-six children had transient, low titer reactivity. This reactivity was not associated with adverse events or alteration in serum concentrations.

Immunogenicity was not assessed in Trial 2. A trial of high-risk preterm children less than or equal to 24 months of age was conducted to evaluate the immunogenicity of the lyophilized formulation of Synagis (used in Trials 1 and 2 above) and the liquid formulation of Synagis. Three hundred seventy-nine children contributed to the 4 to 6 months post-final dose analysis.

The rate of anti-palivizumab antibodies at this time point was low in both formulation groups (anti-palivizumab antibodies were not detected in any subject in the liquid formulation group and were detected in one subject in the lyophilized group (0.5%), with an overall rate of 0.3% for both treatment groups combined). These data reflect the percentage of children whose test results were considered positive for antibodies to palivizumab in an enzyme-linked immunosorbent assay (ELISA) and are highly dependent on the sensitivity and specificity of the assay.

The ELISA has substantial limitations in detecting anti-palivizumab antibodies in the presence of palivizumab. Immunogenicity samples tested with the ELISA assay likely contained palivizumab at levels that may interfere with the detection of anti-palivizumab antibodies. An electrochemical luminescence (ECL) based immunogenicity assay, with a higher tolerance for palivizumab presence compared to the ELISA, was used to evaluate the presence of anti-palivizumab antibodies in subject samples from two additional clinical trials.

The rates of anti-palivizumab antibody positive results in these trials were 1.1% and 1.5%.

6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of Synagis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to dru… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 49 words ▾

7 DRUG INTERACTIONS No formal drug-drug interaction studies were conducted. In Trial 1, the proportions of children in the placebo and Synagis groups who received routine childhood vaccines, influenza vaccine, bronchodilators, or corticosteroids were similar and no incremental increase in adverse reactions was observed among children receiving these agents.

👥 Use in Specific Populations 91 words ▾

8 USE IN SPECIFIC POPULATIONS Safety and effectiveness in children older than 24 months of age at the start of dosing have not been established. ( 8.4 )

8.1Pregnancy Risk Summary Synagis is not indicated for use in females of reproductive potential.

8.2Lactation Risk Summary Synagis is not indicated for use in females of reproductive potential.

8.4Pediatric Use The safety and effectiveness of Synagis in children older than 24 months of age at the start of dosing have not been established [see Clinical Studies ( 14 ) ].

🤰 Pregnancy 15 words ▾

8.1Pregnancy Risk Summary Synagis is not indicated for use in females of reproductive potential.

🧒 Pediatric Use 33 words ▾

8.4Pediatric Use The safety and effectiveness of Synagis in children older than 24 months of age at the start of dosing have not been established [see Clinical Studies ( 14 ) ].

🆘 Overdosage 55 words ▾

10 OVERDOSAGE Overdoses with doses up to 85 mg per kg have been reported in clinical studies and post-marketing experience with Synagis, and in some cases, adverse reactions were reported. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

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

12.3Pharmacokinetics In children less than or equal to 24 months of age without congenital heart disease (CHD), the mean half-life of palivizumab was 20 days and monthly intramuscular doses of 15 mg per kg achieved mean ± SD 30 day trough serum drug concentrations of 37 ± 21 mcg per mL after the first injection, 57 ± 41 mcg per mL after the second injection, 68 ± 51 mcg per mL after the third injection, and 72 ± 50 mcg per mL after the fourth injection. Trough concentrations following the first and fourth Synagis dose were similar in children with CHD and in non-cardiac patients.

In children given Synagis for a second season, the mean ± SD serum concentrations following the first and fourth injections were 61 ± 17 mcg per mL and 86 ± 31 mcg per mL, respectively. In 139 children less than or equal to 24 months of age with hemodynamically significant CHD who received Synagis and underwent cardio-pulmonary bypass for open-heart surgery, the mean ± SD serum palivizumab concentration was 98 ± 52 mcg per mL before bypass and declined to 41 ± 33 mcg per mL after bypass, a reduction of 58% [see Dosage and Administration ( 2.1 ) ].

The clinical significance of this reduction is unknown. Specific studies were not conducted to evaluate the effects of demographic parameters on palivizumab systemic exposure. However, no effects of gender, age, body weight, or race on palivizumab serum trough concentrations were observed in a clinical study with 639 children with CHD (less than or equal to 24 months of age) receiving five monthly intramuscular injections of 15 mg per kg of Synagis.

The pharmacokinetics and safety of Synagis liquid solution and Synagis lyophilized formulation administered via intramuscular injection at 15 mg per kg were studied in a cross-over trial of 153 infants less than or equal to 6 months of age with a history of prematurity. The results of this trial indicated that the trough serum concentrations of palivizumab were comparable between the liquid solution and the lyophilized formulation, which was the formulation used in the clinical studies. A population pharmacokinetic analysis was performed across 22 studies in 1800 patients (1684 pediatric and 116 adult patients) to characterize palivizumab pharmacokinetics and inter-subject variability in serum concentrations.

Palivizumab pharmacokinetics was described by a two-compartment linear model with an elimination half-life of 24.5 days in pediatric patients. Clearance of palivizumab in a typical pediatric patient (body weight 4.5 kg) less than or equal to 24 months of age without CHD was estimated to be 11 mL per day with a bioavailability of 70% following intramuscular administration. The inter-patient variability in drug clearance was 48.7% (CV%).

Covariate analysis did not identify any factors that could account for the inter-patient variability in order to predict serum concentrations a priori in an individual patient.

12.4Microbiology Mechanism of Action Palivizumab, a recombinant humanized monoclonal antibody which provides passive immunity against RSV, acts by binding the RSV envelope fusion protein (RSV F) on the surface of the virus and blocking a critical step in the membrane fusion process. Palivizumab also prevents cell-to-cell fusion of RSV-infected cells. Antiviral Activity The antiviral activity of palivizumab was assessed in a microneutralization assay in which increasing concentrations of antibody were incubated with RSV prior to addition of the human epithelial cells HEp-2.

After incubation for 4-5 days, RSV antigen was measured in an ELISA assay. The neutralization titer (50% effective concentration [EC 50 ]) is expressed as the antibody concentration required to reduce detection of RSV antigen by 50% compared with untreated virus-infected cells. Palivizumab exhibited median EC 50 values of 0… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 20 words ▾

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

📦 How Supplied / Storage and Handling 104 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Synagis is supplied in single-dose vials as a preservative-free, sterile liquid solution at 100 mg per mL for intramuscular injection. 50 mg vial NDC 66658-230-01 The 50 mg vial contains 50 mg Synagis in 0.5 mL. 100 mg vial NDC 66658-231-01 The 100 mg vial contains 100 mg Synagis in 1 mL.

The rubber stopper used for sealing vials of Synagis is not made with natural rubber latex. Storage Upon receipt and until use, Synagis should be stored between 2°C and 8°C (36°F and 46°F) in its original container. DO NOT freeze.

DO NOT use beyond the expiration date.

📦 Storage and Handling 31 words ▾

Storage Upon receipt and until use, Synagis should be stored between 2°C and 8°C (36°F and 46°F) in its original container. DO NOT freeze. DO NOT use beyond the expiration date.

📋 Description ~1 min read ▾

11 DESCRIPTION Palivizumab is a humanized monoclonal antibody (IgG1κ) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of RSV. Palivizumab is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence was derived from the constant domains of human IgG1 and the variable framework regions of the V H genes Cor and Cess.

The human light chain sequence was derived from the constant domain of Cκ and the variable framework regions of the V L gene K104 with Jκ -4. The murine sequences were derived from a murine monoclonal antibody, Mab 1129, in a process that involved the grafting of the murine complementarity determining regions into the human antibody frameworks. Palivizumab is composed of two heavy chains and two light chains and has a molecular weight of approximately 148,000 Daltons.

Synagis is supplied as a sterile, preservative-free liquid solution at 100 mg per mL to be administered by intramuscular injection. Thimerosal or other mercury-containing salts are not used in the production of Synagis. The solution has a pH of 6.0 and should appear clear or slightly opalescent.

Each 100 mg single-dose vial of Synagis liquid solution contains 100 mg of palivizumab and also contains chloride (0.5 mg), glycine (0.1 mg), and histidine (3.9 mg), in a volume of 1 mL. Each 50 mg single-dose vial of Synagis liquid solution contains 50 mg of palivizumab and also contains chloride (0.2 mg), glycine (0.06 mg), and histidine (1.9 mg), in a volume of 0.5 mL.

💬 Information for Patients 149 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient's caregiver to read the FDA-approved patient labeling ( Patient Information ) Hypersensitivity Reactions 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 child experiences a severe hypersensitivity reaction to Synagis [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ]. Administration Advise the patient's caregiver that Synagis should be administered by a healthcare provider once a month during the RSV season by intramuscular injection and the importance of compliance with the full course of therapy [see Dosage and Administration ( 2 )] .

Synagis® is a registered trademark of Arexis AB c/o Swedish Orphan Biovitrum AB (publ). sobi Manufactured by: Swedish Orphan Biovitrum AB (publ) Stockholm, Sweden Distributed by: Sobi Inc. 77 4th Avenue, 3rd FloorWaltham, MA 02451-7559 U.S License No. 1859 Issued: 11/2020

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics In children less than or equal to 24 months of age without congenital heart disease (CHD), the mean half-life of palivizumab was 20 days and monthly intramuscular doses of 15 mg per kg achieved mean ± SD 30 day trough serum drug concentrations of 37 ± 21 mcg per mL after the first injection, 57 ± 41 mcg per mL after the second injection, 68 ± 51 mcg per mL after the third injection, and 72 ± 50 mcg per mL after the fourth injection. Trough concentrations following the first and fourth Synagis dose were similar in children with CHD and in non-cardiac patients.

In children given Synagis for a second season, the mean ± SD serum concentrations following the first and fourth injections were 61 ± 17 mcg per mL and 86 ± 31 mcg per mL, respectively. In 139 children less than or equal to 24 months of age with hemodynamically significant CHD who received Synagis and underwent cardio-pulmonary bypass for open-heart surgery, the mean ± SD serum palivizumab concentration was 98 ± 52 mcg per mL before bypass and declined to 41 ± 33 mcg per mL after bypass, a reduction of 58% [see Dosage and Administration ( 2.1 ) ].

The clinical significance of this reduction is unknown. Specific studies were not conducted to evaluate the effects of demographic parameters on palivizumab systemic exposure. However, no effects of gender, age, body weight, or race on palivizumab serum trough concentrations were observed in a clinical study with 639 children with CHD (less than or equal to 24 months of age) receiving five monthly intramuscular injections of 15 mg per kg of Synagis.

The pharmacokinetics and safety of Synagis liquid solution and Synagis lyophilized formulation administered via intramuscular injection at 15 mg per kg were studied in a cross-over trial of 153 infants less than or equal to 6 months of age with a history of prematurity. The results of this trial indicated that the trough serum concentrations of palivizumab were comparable between the liquid solution and the lyophilized formulation, which was the formulation used in the clinical studies. A population pharmacokinetic analysis was performed across 22 studies in 1800 patients (1684 pediatric and 116 adult patients) to characterize palivizumab pharmacokinetics and inter-subject variability in serum concentrations.

Palivizumab pharmacokinetics was described by a two-compartment linear model with an elimination half-life of 24.5 days in pediatric patients. Clearance of palivizumab in a typical pediatric patient (body weight 4.5 kg) less than or equal to 24 months of age without CHD was estimated to be 11 mL per day with a bioavailability of 70% following intramuscular administration. The inter-patient variability in drug clearance was 48.7% (CV%).

Covariate analysis did not identify any factors that could account for the inter-patient variability in order to predict serum concentrations a priori in an individual patient.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The safety and efficacy of Synagis were assessed in two randomized, double-blind, placebo-controlled trials of prophylaxis against RSV infection in children at high risk of an RSV-related hospitalization. Trial 1 was conducted during a single RSV season and studied a total of 1502 children less than or equal to 24 months of age with BPD or infants with premature birth (less than or equal to 35 weeks gestation) who were less than or equal to 6 months of age at study entry. Trial 2 was conducted over four consecutive seasons among a total of 1287 children less than or equal to 24 months of age with hemodynamically significant congenital heart disease.

In both trials participants received 15 mg per kg Synagis or an equivalent volume of placebo via intramuscular injection monthly for five injections and were followed for 150 days from randomization. In Trial 1, 99% of all subjects completed the study and 93% completed all five injections. In Trial 2, 96% of all subjects completed the study and 92% completed all five injections.

The incidence of RSV hospitalization is shown in Table 1 . The results were shown to be statistically significant using Fisher's exact test. Table 1: Incidence of RSV Hospitalization by Treatment Group Trial Placebo Synagis Difference Between Groups Relative Reduction Trial 1 Impact-RSV N 500 1002 Hospitalization 53 (10.6%) 48 (4.8%) 5.8% 55% Trial 2 CHD N 648 639 Hospitalization 63 (9.7%) 34 (5.3%) 4.4% 45% In Trial 1, the reduction of RSV hospitalization was observed both in children with BPD (34/266 [12.8%] placebo versus 39/496 [7.9%] Synagis) and in premature infants without BPD (19/234 [8.1%] placebo versus 9/506 [1.8%] Synagis).

In Trial 2, reductions were observed in acyanotic (36/305 [11.8%] placebo versus 15/300 [5.0%] Synagis) and cyanotic children (27/343 [7.9%] placebo versus 19/339 [5.6%] Synagis). The clinical studies do not suggest that RSV infection was less severe among children hospitalized with RSV infection who received Synagis for RSV prophylaxis compared to those who received placebo.

🧪 Nonclinical Toxicology 19 words ▾

13 NONCLINICAL TOXICOLOGY

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

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 16 words ▾

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

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 11/2021 PATIENT INFORMATION SYNAGIS ® (Si-na-jis) (palivizumab) injection What is SYNAGIS? SYNAGIS is a prescription medication that is used to help prevent a serious lung disease caused by Respiratory Syncytial Virus (RSV) in children: born prematurely (at or before 35 weeks) and who are 6 months of age or less at the beginning of RSV season, who have a chronic lung condition called bronchopulmonary dysplasia (BPD), that needed medical treatment within the last 6 months, and who are 24 months of age or less at the beginning of RSV season, born with certain types of heart disease and who are 24 months of age or less at the beginning of RSV season.

SYNAGIS contains man-made, disease-fighting proteins called antibodies. It is not known if SYNAGIS is safe and effective to treat the symptoms of RSV in a child who already has RSV. Synagis is used to help prevent RSV disease.

It is not known if SYNAGIS is safe and effective in children who are older than 24 months of age at the start of dosing. Who should not receive SYNAGIS? Your child should not receive SYNAGIS if they have ever had a severe allergic reaction to it.

See the end of this leaflet for a complete list of ingredients in SYNAGIS. Signs and symptoms of a severe allergic reaction could include: severe rash, hives, or itching skin swelling of the lips, tongue, or face swelling of the throat, difficulty swallowing difficult, rapid, or irregular breathing bluish color of skin, lips, or under fingernails muscle weakness or floppiness unresponsiveness Before your child receives SYNAGIS, tell your healthcare provider about all of your child's medical conditions, including if your child: has ever had a reaction to SYNAGIS. has bleeding or bruising problems.

SYNAGIS is given by injection. If your child has a problem with bleeding or bruises easily, an injection could cause a problem. 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 SYNAGIS given? SYNAGIS is given as a monthly injection, usually in the thigh (leg) muscle, by your child's healthcare provider. Your child's healthcare provider will give you detailed instructions on when SYNAGIS will be given. “RSV season” is the time of year when RSV infections most commonly happen, usually fall through spring, but it may begin earlier or last longer in certain areas.

During this time, when RSV is most active, your child will need to receive SYNAGIS injections. Your healthcare provider can tell you when the RSV season starts in your area. Your child should receive the first SYNAGIS injection before the RSV season starts to help prevent RSV infection.

If the season has already started, your child should receive their first SYNAGIS injection as soon as possible to help protect them when exposure to the virus is more likely. SYNAGIS is needed every 28-30 days during the RSV season . Each injection of SYNAGIS helps protect your child from severe RSV disease for about 1 month.

Keep all of your child's appointments with your healthcare provider. If your child misses an injection, talk to your healthcare provider and schedule another injection as soon as possible. Your child may still get severe RSV disease after receiving SYNAGIS.

Talk to your healthcare provider about what symptoms to look for. If your child gets a RSV infection, they should continue to receive their scheduled SYNAGIS injections to help prevent severe disease from new RSV infections. If your child has certain types of heart disease and has corrective surgery, your healthcare provider may need to give your child an additional SYNAGIS injection soon after surgery.

What are the possible side effects of SYNAGIS? SYNAGIS may cause serious side effects including: Severe allergic reactions. Severe allergic reactions may happen after any injection of SYNAGIS, and m… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 116 words ▾

Principal Display Panel - 50 mg/0.5 mL Carton Label NDC 66658-230-01 SYNAGIS ® PALIVIZUMAB 50 mg/0.5 mL For Intramuscular Injection Only Store at 2 to 8°C (36 to 46°F). Single-dose vial. Discard unused portion. image1

Principal Display Panel - 50 mg/0.5 mL Vial Label NDC 66658-230-01 50 mg/0.5 mL SYNAGIS ® PALIVIZUMAB For Intramuscular Injection Only US Lic. 1859 image2

Principal Display Panel - 100 mg/mL Carton Label NDC 66658-231-01 SYNAGIS ® PALIVIZUMAB 100 mg/mL For Intramuscular Injection Only Store at 2 to 8°C (36 to 46°F). Single-dose vial. Discard unused portion. image3

Principal Display Panel - 100 mg/mL Vial Label NDC 66658-231-01 100 mg/mL SYNAGIS ® PALIVIZUMAB For Intramuscular Injection Only US Lic. 1859 image4

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
180
Units reimbursed last 4 qtrs
184
Gross reimbursed last 4 qtrs
$612.6K
Avg / prescription
$3,403.56
Avg / unit
$3,329.57
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
94% MCO
Fee-for-service · 11 Rx Managed care · 169 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: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 13 units · 0.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 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: 154 units · 0.7 per 100k residents FL
Units reimbursed · per 100k residents
0.00.7
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 Florida 0.7 /100k
2 California 0.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Swedish Orphan Biovitrum AB (publ) 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.
← 66658-0230-01 · Swedish 66658-0234-07 · Swedish →
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.