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Dalbavancin 500 mg/25mL Injection, Powder, Lyophilized, For Solution — NDC 71288-0034-50 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dalbavancin 500 mg/25mL Injection, Powder, Lyophilized, For Solution — NDC 71288-034-50 (Billing 71288-0034-50)

by Meitheal Pharmaceuticals Inc · 1 VIAL, SINGLE-DOSE in 1 CARTON / 25 mL in 1 VIAL, SINGLE-DOSE

This is a package of Dalbavancin 500 mg/25mL Injection, Powder, Lyophilized, For Solution from Meitheal Pharmaceuticals Inc, marketed since Nov 2025 and currently FDA-listed. It is this product's only package size.

NDC 71288-0034-50
🏷️ FDA NDC (as labeled) 71288-034-50 billing pads the product segment with a zero
Rx only Generic 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 →

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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 71288-034-50 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71288 labeler · 034 product · 50 package
Package marketed since
Nov 26, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7128803450 7
Medicaid fills, this package
34 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) 71288-034-50
Product NDC 71288-034
11-digit billing NDC 71288003450
NCPDP billing unit EA — each (per item)
RxCUI 1539243
UNII 33WDQ7T81E
Application # ANDA218929
SPL Set ID 966995bb-9d92-434d-b75a-1786072b81c9
Established class (EPC) Lipoglycopeptide Antibacterial
Chemical class Lipoglycopeptides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-26
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance DALBAVANCIN HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 16280030102130
GCN Seq No 072383
GCN 36585
HICL code 041153
Ingredient (HICL) Dalbavancin Hcl
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W9
Therapeutic class — intermediate (HIC2) Antibiotics (Continued 1)
HIC3 code W9I
Therapeutic class — specific (HIC3) Lipoglycopeptide Antibiotics
AHFS code 08:12.28.16
AHFS class Glycopeptide Antibiotics
FDB label name DALBAVANCIN HCL 500 MG VIAL
FDB brand name Dalbavancin Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 072383
  • GCN: 36585
  • GPI-14 (Medi-Span): 16280030102130
  • HICL (First Databank): 041153
  • AHFS class code: 08:12.28.16
  • RxCUI (RxNorm): 1539243
Why two NDCs? The FDA registers this code as 71288-034-50 — 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 → 71288-0034-50. 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 Lipoglycopeptide Antibacterial class.

Pharmacologic class Lipoglycopeptide Antibacterial
Drug family (ATC) Glycopeptide antibacterials
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 DALBAVANCIN HCL 500 MG VIAL Ingredient Dalbavancin Hcl
📖 What it is MedlinePlus · NLM

Dalbavancin injection is used to treat skin infections caused by certain types of bacteria. Dalbavancin is in a class of medications called lipoglycopeptide antibiotics. It works by killing bacteria. Antibiotics such as dalbavancin will not kill viruses that can cause colds, flu, or other infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats bacterial infections of the skin and the tissue under it, called ABSSSI, in adults and children. It works against certain bacteria, including MRSA. It will not help with...
  • A healthcare professional gives it through an IV over about 30 minutes. It is a single-dose regimen, so you don't take pills at home. Your dose depends on your age, weight if you'r...
  • The most common are nausea, headache and diarrhea. Some people also get vomiting, rash or itching. Children most often had fever.
  • Get help right away for signs of a serious allergic reaction, like trouble breathing or swelling. Tell your nurse if you feel flushed, itchy or have back pain during the infusion....
📖 Read our full Dalbavancin Injection guide →
7
Nutrient depletion considerations

Dalbavancin Hydrochloride may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Dalbavancin Hydrochloride nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 $1,732.45 $43,311.19 / 25 ml
Medicare drug plans payPart D · Q2 2026 $1,139.62 $28,490.53 / 25 ml
Medicare Part B allowsASP · J0875 $11.293 / J0875 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)71288-034-50
11-digit billing NDC71288-0034-50
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ0875
DescriptorInjection, dalbavancin, 5 mg
Billing units / pkg100 units
How the units are derivedThis package is 1; the HCPCS unit is 5 MG, so one package = 100 billing units.
Medicare Part B spend (2026 (Q1))$17,702,337 · 4,418 claims · $4,006.87 per claim (all NDCs under J0875)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71288-0034-50 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 25 mL in 1 VIAL, SINGLE-DOSE 2025-11-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dalbavancin 500 mg/25mL 00480-3325-01 Teva 1 vial — AP FDA listed —
Dalvance 500 mg/25mL 57970-0100-01 Allergan, 1 vial — AP FDA listed —
Dalbavancin Hydrochloride 500 mg/25mL 65219-0120-12 Fresenius 1 vial — AP FDA listed —
Dalbavancin 500 mg/25mLthis 71288-0034-50 Meitheal 1 vial — AP FDA listed —
Dalbavancin 500 mg/25mL 71839-0144-01 BE 1 vial — AP FDA listed —
Dalbavancin 500 mg 81298-2390-01 Long 1 vial — AP FDA listed —
Dalbavancin 500 mg/25mL 70069-0830-01 Somerset 1 vial — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Nov 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

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

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

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

  • 129 mg / 25 mL UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 129 mg / 25 mL UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.

2 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

LabelerMeitheal Pharmaceuticals Inc
Application holderKINDOS PHARMACEUTICALS CO LTD
FDA applicationANDA218929 (ANDA)
Labeler code71288
First marketedNov 2025
Product typeHuman Prescription Drug
Portfolio16 products on file

More NDCs from Meitheal Pharmaceuticals Inc labeler code 71288

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 🔄 Drug / Laboratory Test Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Dalbavancin for Injection is a lipoglycopeptide antibacterial indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Dalbavancin for Injection and other antibacterial drugs, Dalbavancin for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

( 1.2 )

1.1Acute Bacterial Skin and Skin Structure Infections Dalbavancin for Injection is indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes , Streptococcus agalactiae , Streptococcus dysgalactiae , Streptococcus anginosus group (including S. anginosus , S. intermedius , S . constellatus ) and Enterococcus faecalis (vancomycin susceptible isolates).

1.2Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Dalbavancin for Injection and other antibacterial agents, Dalbavancin for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Dosage in Adult Patients ( 2.1 , 2.3 ): Estimated Creatinine Clearance ( C L cr) Single- Dose Regimen 30 mL/min and above or on regular hemodialysis 1,500 mg Less than 30 mL/min and not on regular hemodialysis 1,125 mg Administer by intravenous infusion over 30 minutes ( 2.1 , 2.4 ) See Full Prescribing Information for instructions on reconstitution of lyophilized powder and preparation of injection ( 2.4 ) Dosage in Pediatric Patients with CLcr 30 mL/min/1.73m 2 and above ( 2.2 ) Age Range Dosage (Single-Dose Regimen) Birth to less than 6 years 22.5 mg/kg (maximum of 1,500 mg) 6 to less than 18 years 18 mg/kg (maximum of 1,500 mg) Dosage adjustment in pediatric patients with CLcr less than 30 mL/min has not been studied.

2.1Recommended Dos ag e Regimen in Adult Patients with CLcr 30 mL/min and Above The recommended dosage regimen of dalbavancin for injection in adult patients with CLcr 30 mL/min and above is 1,500 mg, administered as a single-dose regimen. Administer dalbavancin for injection over 30 minutes by intravenous infusion. For adult patients with CLcr less than 30 mL/min, dosage adjustment is required [see Dosage and Administration ( 2.3 ) and Clinical Pharmacology ( 12.3 ) ] .

2.2Recommended Dosage Regimen in Pediatric Patients with CLcr 30 mL/min/ 1.73m 2 and Abov e The recommended dosage regimen of dalbavancin for injection in pediatric patients with CLcr 30 mL/min/1.73m 2 and above is a single-dose regimen based on the age and weight of the pediatric patient ( Table 1 ). Administer dalbavancin for injection over 30 minutes by intravenous infusion. There is insufficient information to recommend dosage adjustment for pediatric patients younger than 18 years with CLcr less than 30 mL/min/1.73m 2 [see Use in Specific Populations ( 8.4 ) and Clinical Pharmacology ( 12.3 )] .

Table 1. Dosage of Dalbavancin for Injection in Pediatric Patients with CLcr* 30 mL/min/1.73m 2 and above Age Range Dosage (Single-Dose Regimen) Birth to less than 6 years 22.5 mg/kg (maximum 1,500 mg) 6 to less than 18 years 18 mg/kg (maximum 1,500 mg) *Estimate CLcr or glomerular filtration rate (GFR) using an age-appropriate equation accepted for pediatric patients (birth to less than 18 years old) to define renal function impairment.

2.3Dosage Adjustments in Adult Patients with CLcr less than 30 mL/min In adult patients with renal impairment whose known CLcr is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended dosage regimen of dalbavancin for injection is 1,125 mg, administered as a single-dose regimen. No dosage adjustment is recommended for adult patients receiving regularly scheduled hemodialysis, and dalbavancin for injection can be administered without regard to the timing of hemodialysis [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] .

2.4Preparation and Administration Dalbavancin for injection must be reconstituted with either Sterile Water for Injection, USP, or 5% Dextrose Injection, USP, and subsequently diluted only with 5% Dextrose Injection, USP, to a final concentration of 1 mg per mL to 5 mg per mL. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Reconstitution Dalbavancin for injection must be reconstituted under aseptic conditions, using 25 mL of either Sterile Water for Injection, USP, or 5% Dextrose Injection, USP, for each 500 mg vial.

To avoid foaming, alternate between gentle swirling and inversion of the vial until its contents are completely dissolved. Do not shake. The reconstituted vial contains 20 mg per mL dalbavancin as a clear, colorless to yellow solution.

Reconstituted vials may be stored either refrigerated at 2° to 8°C (36° to 46°F), or at controlled room temperature 20° to 25°C (68° to 77°F). Do not freeze. Dilution Adult Patients Aseptically transfer the required dose of reconstituted dalba… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 52 words ▾

3 DOSAGE FORMS AND STRENGTHS Dalbavancin for Injection is supplied as a white/off-white to pale yellow lyophilized sterile powder for reconstitution in a single-dose clear glass vial containing dalbavancin hydrochloride equivalent to 500 mg of dalbavancin . For injection: 500 mg of lyophilized powder in a vial for reconstitution ( 3 )

⛔ Contraindications 21 words ▾

4 CONTRAINDICATIONS Dalbavancin for injection is contraindicated in patients with known hypersensitivity to dalbavancin. Known hypersensitivity to dalbavancin ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Serious hypersensitivity (anaphylactic) and skin reactions have been reported in patients treated with dalbavancin for injection. If an allergic reaction occurs, discontinue treatment with dalbavancin for injection and institute appropriate therapy for the allergic reaction. Carefully monitor patients with known hypersensitivity to glycopeptides.

( 5.1 ) Rapid intravenous infusion of dalbavancin for injection can cause flushing of the upper body, urticaria, pruritus, rash, and/or back pain. Stopping or slowing the infusion may result in cessation of these reactions. ( 5.2 ) Alanine Aminotransferase (ALT) elevations with dalbavancin for injection treatment were reported in clinical trials.

( 5.3 , 6.1 ) Clostridioides difficile -associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including dalbavancin for injection. Evaluate if diarrhea occurs. ( 5.4 )

5.1Hypersensitivity Reactions Serious hypersensitivity (anaphylactic) and skin reactions have been reported in patients treated with dalbavancin for injection. If an allergic reaction to dalbavancin for injection occurs, discontinue treatment with dalbavancin for injection and institute appropriate therapy for the allergic reaction. Before using dalbavancin for injection, inquire carefully about previous hypersensitivity reactions to other glycopeptides.

Due to the possibility of cross-sensitivity, carefully monitor for signs of hypersensitivity during treatment with dalbavancin for injection in patients with a history of glycopeptide allergy [see Patient Counseling Information ( 17 )] .

5.2Infusion - Related Reactions Dalbavancin for injection is administered via intravenous infusion, using a total infusion time of 30 minutes to minimize the risk of infusion-related reactions. Rapid intravenous infusions of dalbavancin for injection can cause flushing of the upper body, urticaria, pruritus, rash, and/or back pain. Stopping or slowing the infusion may result in cessation of these reactions.

5.3Hepatic Effects In Phase 2 and 3 clinical trials, more dalbavancin for injection than comparator-treated subjects with normal baseline transaminase levels had post-baseline alanine aminotransferase (ALT) elevation greater than 3 times the upper limit of normal (ULN). Overall, abnormalities in liver tests (ALT, AST, bilirubin) were reported with similar frequency in the dalbavancin for injection and comparator arms [see Adverse Reactions ( 6.1 )].

5.4Clostridioides difficile - Associated Diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported in users of nearly all systemic antibacterial drugs, including dalbavancin for injection, with severity ranging from mild diarrhea to fatal colitis. Treatment with antibacterial agents can alter the normal flora of the colon, and may permit overgrowth of C. difficile . C . difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin-producing strains of C . difficile cause increased morbidity and mortality, as these infections can be refractory to antibacterial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C . difficile should be discontinued, if possible. Appropriate measures such as fluid and electrolyte management, protein supplementation, antibacterial treatment of C . difficile , and surgical evaluation should be instituted as clinically indicated.

5.5Development of Drug-Resistant Bacteria Prescribing dalbavancin for injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-re… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are also discussed elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infusion Related Reactions [see Warnings and Precautions ( 5.2 )] Hepatic Effects [see Warnings and Precautions ( 5.3 )] Clostridioides difficile -associated Diarrhea [see Warnings and Precautions ( 5.4 )] The most common adverse reactions occurring in >4% of adult patients treated with dalbavancin for injection were nausea, headache, and diarrhea.

The most common adverse reaction that occurred in >1% of pediatric patients was pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 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 clinical trials of dalbavancin for injection cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. Clinical Trials Experience in Adult Patients Adverse reactions were evaluated for 2,473 patients treated with dalbavancin for injection: 1,778 patients were treated with dalbavancin for injection in seven Phase 2/3 trials comparing dalbavancin for injection to comparator antibacterial drugs and 695 patients were treated with dalbavancin for injection in one Phase 3 trial comparing dalbavancin for injection single-dose and another dalbavancin dosing regimen.

The median age of patients treated with dalbavancin for injection was 48 years, ranging between 16 and 93 years. Patients treated with dalbavancin for injection were predominantly male (59.5%) and White (81.2%). Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation Serious adverse reactions occurred in 121/2,473 (4.9%) of patients treated with any regimen of dalbavancin for injection.

In the Phase 2/3 trials comparing dalbavancin for injection to comparator, serious adverse reactions occurred in 109/1,778 (6.1%) of patients in the dalbavancin for injection group and 80/1,224 (6.5%) of patients in the comparator group. In a Phase 3 trial comparing dalbavancin for injection single-dose and another dalbavancin dosing regimen, serious adverse reactions occurred in 7/349 (2.0%) of patients in the dalbavancin for injection single-dose group and 5/346 (1.4%) of patients in another dalbavancin dosing group.

Dalbavancin for injection was discontinued due to an adverse reaction in 64/2,473 (2.6%) patients treated with any regimen of dalbavancin for injection. In the Phase 2/3 trials comparing dalbavancin for injection to comparator, dalbavancin for injection was discontinued due to an adverse reaction in 53/1,778 (3.0%) of patients in the dalbavancin for injection group and 35/1,224 (2.9%) of patients in the comparator group. In a Phase 3 trial comparing dalbavancin for injection single-dose and another dalbavancin dosing regimen, dalbavancin for injection was discontinued due to an adverse reaction in 6/349 (1.7%) of patients in the dalbavancin for injection single-dose group and 5/346 (1.4%) of patients in another dalbavancin dosing group.

Most Common Adverse Reactions The most common adverse reactions in patients treated with dalbavancin for injection in Phase 2/3 trials were nausea (5.5%), headache (4.7%), and diarrhea (4.4%). The median duration of adverse reactions was 3.0 days in patients treated with dalbavancin for injection. In the Phase 2/3 trials comparing dalbavancin for injection to comparator, the median duration of adverse reactions was 3.0 days for patients in the dalbavancin for injection group and 4.0 days in patients in the comparator group.

In a Phase 3 trial comparing dalbavancin for injection single-dose and another dalbavancin dosing regimen, the median duration of adverse reactions was 3.0 days for patients in the dalbavancin for injection single-dose group and another dal… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 70 words ▾

7 DRUG INTERACTIONS

7.1Drug-Laboratory Test Interactions Drug-laboratory test interactions have not been reported. Dalbavancin at therapeutic concentrations does not artificially prolong prothrombin time (PT) or activated partial thromboplastin time (aPTT).

7.2Drug-Drug Interactions No clinical drug-drug interaction studies have been conducted with dalbavancin. There is minimal potential for drug-drug interactions between dalbavancin and cytochrome P450 (CYP450) substrates, inhibitors, or inducers [see C linical P harmacology ( 12.3 )] .

🔄 Drug / Laboratory Test Interactions 28 words ▾

7.1Drug-Laboratory Test Interactions Drug-laboratory test interactions have not been reported. Dalbavancin at therapeutic concentrations does not artificially prolong prothrombin time (PT) or activated partial thromboplastin time (aPTT).

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with dalbavancin for injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse developmental outcomes. No treatment-related malformations or embryo-fetal toxicity were observed in pregnant rats or rabbits at clinically relevant exposures of dalbavancin. Treatment of pregnant rats with dalbavancin at 3.5 times the human dose on an exposure basis during early embryonic development and from implantation to the end of lactation resulted in delayed fetal maturation and increased fetal loss, respectively [ see Data ] .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data No evidence of embryo or fetal toxicity was found in the rat or rabbit at a dose of 15 mg/kg/day (1.2 and 0.7 times the human dose on an exposure basis, respectively). Delayed fetal maturation was observed in the rat at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis). In a rat prenatal and postnatal development study, increased embryo lethality and increased offspring deaths during the first week post-partum were observed at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis).

8.2Lactation Risk Summary There are no data on the presence of dalbavancin or its metabolite in human milk, the effects on the breast-fed child, or the effects on milk production. Dalbavancin is excreted in the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dalbavancin for injection and any potential adverse effects on the breast-fed child from dalbavancin for injection or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of dalbavancin for injection for the treatment of ABSSSI has been established in pediatric patients aged birth to less than 18 years. Use of dalbavancin for injection for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged birth to less than 18 years [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies (14.1)] . There is insufficient information to recommend dosage adjustment for pediatric patients with ABSSSI and CLcr less than 30 mL/min/1.73m 2 [see Dosage and Administration ( 2.2 )].

8. 5 Geriatric Use Of the 2,473 patients treated with dalbavancin for injection in Phase 2 and 3 clinical trials, 403 patients (16.3%) were 65 years of age or older. The efficacy and tolerability of dalbavancin for injection were similar to comparator regardless of age.

The pharmacokinetics of dalbavancin was not significantly altered with age; therefore, no dosage adjustment is necessary based on age alone. Dalbavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group.

8.6Renal Impairment In patients with renal impairment whose known CLcr is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended regimen for dalbavancin for injection is 1,125 mg, administered as a single-dose. No dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and dalbavancin for injection can be administered without regar… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with dalbavancin for injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse developmental outcomes. No treatment-related malformations or embryo-fetal toxicity were observed in pregnant rats or rabbits at clinically relevant exposures of dalbavancin. Treatment of pregnant rats with dalbavancin at 3.5 times the human dose on an exposure basis during early embryonic development and from implantation to the end of lactation resulted in delayed fetal maturation and increased fetal loss, respectively [ see Data ] .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data No evidence of embryo or fetal toxicity was found in the rat or rabbit at a dose of 15 mg/kg/day (1.2 and 0.7 times the human dose on an exposure basis, respectively). Delayed fetal maturation was observed in the rat at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis). In a rat prenatal and postnatal development study, increased embryo lethality and increased offspring deaths during the first week post-partum were observed at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis).

🧒 Pediatric Use 107 words ▾

8.4Pediatric Use The safety and effectiveness of dalbavancin for injection for the treatment of ABSSSI has been established in pediatric patients aged birth to less than 18 years. Use of dalbavancin for injection for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged birth to less than 18 years [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies (14.1)] . There is insufficient information to recommend dosage adjustment for pediatric patients with ABSSSI and CLcr less than 30 mL/min/1.73m 2 [see Dosage and Administration ( 2.2 )].

🧓 Geriatric Use 109 words ▾

8. 5 Geriatric Use Of the 2,473 patients treated with dalbavancin for injection in Phase 2 and 3 clinical trials, 403 patients (16.3%) were 65 years of age or older. The efficacy and tolerability of dalbavancin for injection were similar to comparator regardless of age.

The pharmacokinetics of dalbavancin was not significantly altered with age; therefore, no dosage adjustment is necessary based on age alone. Dalbavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group.

🆘 Overdosage 120 words ▾

10 OVERDOSAGE Specific information is not available on the treatment of overdose with dalbavancin for injection, as dose-limiting toxicity has not been observed in clinical studies. In Phase 1 studies, healthy volunteers have been administered cumulative doses of up to 4,500 mg over a period of up to 8 weeks (not an approved dosing regimen), with no signs of toxicity or laboratory results of clinical concern. Treatment of overdose with dalbavancin for injection should consist of observation and general supportive measures.

Although no information is available specifically regarding the use of hemodialysis to treat overdose, in a Phase 1 study in patients with renal impairment less than 6% of the recommended dalbavancin dose was removed [see Clinical Pharmacology (12.3)] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

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

12.2Pharmacodynamics The antibacterial activity of dalbavancin appears to best correlate with the ratio of area under the concentration-time curve to minimal inhibitory concentration (AUC/MIC) for Staphylococcus aureus based on animal models of infection. Cardiac Electrophysiology In a randomized, positive- and placebo-controlled, thorough QT/QTc study, 200 healthy subjects received dalbavancin 1,000 mg IV, dalbavancin 1,500 mg IV, oral moxifloxacin 400 mg, or placebo. Neither dalbavancin 1,000 mg nor dalbavancin 1,500 mg had any clinically relevant adverse effect on cardiac repolarization.

12.3Pharmacokinetics General Pharmacokinetic Properties Dalbavancin pharmacokinetic parameters have been characterized in healthy subjects, patients, and specific populations. Pharmacokinetic parameters following administration of single intravenous 1,000 mg and 1,500 mg doses were as shown in Table 4 . The pharmacokinetics of dalbavancin can be described using a three-compartment model.

Table 4. Dalbavancin Pharmacokinetic Parameters in Healthy Subjects Parameter Single 1,000 mg Dose Single 1,500 mg Dose C max (mg/L) 287 (13.9) 1 423 (13.2) 4 AUC 0-24 (mg•h/L) 3,185 (12.8) 1 4,837 (13.7) 4 AUC 0-Day7 (mg•h/L) 11,160 (41.1) 2 ND AUC 0- inf (mg•h/L) 23,443 (40.9) 2 ND Terminal t ½ (h) 346 (16.5) 2,3 ND CL (L/h) 0.0513 (46.8) 2 ND All values are presented as mean (% coefficient of variation) 1 Data from 50 healthy subjects. 2 Data from 12 healthy subjects.

3 Based upon population pharmacokinetic analyses of data from patients, the effective half-life is approximately 8.5 days (204 hours). 4 Data from 49 healthy subjects. Abbreviation: ND – not determined In healthy subjects, dalbavancin AUC 0-24h and C max both increased proportionally to dose following single IV dalbavancin doses ranging from 140 mg to 1,500 mg, indicating linear pharmacokinetics.

No apparent accumulation of dalbavancin was observed following multiple IV infusions administered once weekly for up to eight weeks, with 1000 mg on Day 1 followed by up to seven weekly 500 mg doses, in healthy adults with normal renal function. Distribution Dalbavancin is reversibly bound to human plasma proteins, primarily to albumin. The plasma protein binding of dalbavancin is approximately 93% and is not altered as a function of drug concentration, renal impairment, or hepatic impairment.

The mean concentrations of dalbavancin achieved in skin blister fluid remain above 30 mg/L up to 7 days (approximately 146 hours) post dose, following 1,000 mg IV dalbavancin. The mean ratio of the AUC 0-144 hrs in skin blister fluid/AUC 0-144 hrs in plasma is 0.60 (range 0.44 to 0.64). Metabolism In vitro studies using human microsomal enzymes and hepatocytes indicate that dalbavancin is not a substrate, inhibitor, or inducer of CYP450 isoenzymes.

A minor metabolite of dalbavancin (hydroxy-dalbavancin) has been observed in the urine of healthy subjects. Quantifiable concentrations of the hydroxy-dalbavancin metabolite have not been observed in human plasma (lower limit of quantitation = 0.4 µg/mL) [see Drug Interactions ( 7.2 )] . Excretion Following administration of a single 1,000 mg dose in healthy subjects, 20% of the dose was excreted in feces through 70 days post dose.

An average of 33% of the administered dalbavancin dose was excreted in urine as unchanged dalbavancin and approximately 12% of the administered dose was excreted in urine as the metabolite hydroxy-dalbavancin through 42 days post dose. Specific Populations Renal Impairment The pharmacokinetics of dalbavancin were evaluated in 28 subjects with varying degrees of renal impairment and in 15 matched control subjects with normal renal function. Following a single-dose of 500 mg or 1,000 mg dalbavancin, the mean plasma clearance (CL T ) was reduced 11%, 35%, and 47% in subjects with CLcr 50 to 79 mL/min, CLcr 30 to 49 mL/min,… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 15 words ▾

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

📦 How Supplied / Storage and Handling 118 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Dalbavancin for Injection is a white to off-white to pale yellow sterile lyophilized powder in a single-dose glass vial containing dalbavancin hydrochloride equivalent to 500 mg dalbavancin and supplied as follows: NDC Dalbavancin for Injection (500 mg per vial) Package Factor 71288- 034 -50 500 mg Single-Dose Vial 1 vial per carton Dalbavancin for Injection should be stored at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Storage of the reconstituted and diluted solutions of Dalbavancin for Injection are described elsewhere in the prescribing information [see Dosage and Administration ( 2.4 )].

Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

📋 Description ~2 min read ▾

11 DESCRIPTION Dalbavancin for Injection is a lipoglycopeptide antibacterial synthesized from a fermentation product of Nonomuraea species. Dalbavancin is a mixture of five closely related active homologs (A 0 , A 1 , B 0 , B 1 , and B 2 ); the component B 0 is the major component of dalbavancin. The homologs share the same core structure and differ in the fatty acid side chain of the N-acylaminoglucuronic acid moiety (R 1 ) structure and/or the presence of an additional methyl group (R 2 ) on the terminal amino group (shown in the Figure 1 and Table 3 below).

Figure 1. Dalbavancin Structural Formula Table 3. Substitution Patterns for Dalbavancin API Homologs Dalbavancin R 1 R 2 Molecular Formula Molecular Weight * A 0 CH(CH 3 ) 2 H C 87 H 98 N 10 O 28 Cl 2 ·

1.6HCl 1,802.7 A 1 CH 2 CH 2 CH 3 H C 87 H 98 N 10 O 28 Cl 2 ·

1.6HCl 1,802.7 B 0 CH 2 CH(CH 3 ) 2 H C 88 H 100 N 10 O 28 Cl 2 ·

1.6HCl 1,816.7 B 1 CH 2 CH 2 CH 2 CH 3 H C 88 H 100 N 10 O 28 Cl 2 ·

1.6HCl 1,816.7 B 2 CH 2 CH(CH 3 ) 2 CH 3 C 89 H 102 N 10 O 28 Cl 2 ·

1.6HCl 1,830.7 *Anhydrous free base The B 0 INN chemical name is: 5,31-dichloro-38-de(methoxycarbonyl)-7-demethyl-19-deoxy-56-O-[2-deoxy-2-[(10-methylundecanoyl)amino]-β-D-glucopyranuronosyl]-38-[[3-(dimethylamino)propyl] carbamoyl]-42-O-α-D-mannopyranosyl-15-N-methyl(ristomycin A aglycone) hydrochloride. Dalbavancin for Injection is supplied in clear glass vials as a sterile, lyophilized, preservative-free, white to off-white to pale yellow solid. Each vial contains dalbavancin HCl equivalent to 500 mg of dalbavancin as the free base, plus lactose monohydrate (129 mg) and mannitol (129 mg) as excipients.

Sodium hydroxide or hydrochloric acid may be added to adjust the pH at the time of manufacture. The powder is to be reconstituted and further diluted for IV infusion [ see Dosage and Administration ( 2.4 ) , How Supplied/Storage and Handling ( 16 ) ] . Figure 1

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Allergic Reactions Advise patients that allergic reactions, including serious allergic reactions, could occur with dalbavancin for injection, and that serious allergic reactions require immediate treatment. Patients should inform their healthcare provider about any previous hypersensitivity reactions to dalbavancin for injection, or other glycopeptides [see Warnings and Precautions ( 5.1 )] . Diarrhea Advise patients that diarrhea is a common problem caused by antibacterial drugs, including dalbavancin for injection, and usually resolves when the drug is discontinued.

Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, patients should contact their healthcare provider [see Warnings and Precautions ( 5.4 )] . Development of Drug-Resistant Bacteria Patients should be counseled that antibacterial drugs including dalbavancin for injection should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold). When dalbavancin for injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by dalbavancin for injection or other antibacterial drugs in the future [see Warnings and Precautions ( 5.5 )] .

Brands listed are the trademarks of their respective owners. meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2025 Meitheal Pharmaceuticals Inc. Mfd. by Kindos Pharmaceuticals Co., Ltd. Chengdu, China 611731 May 2025 LB-639-V1

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics General Pharmacokinetic Properties Dalbavancin pharmacokinetic parameters have been characterized in healthy subjects, patients, and specific populations. Pharmacokinetic parameters following administration of single intravenous 1,000 mg and 1,500 mg doses were as shown in Table 4 . The pharmacokinetics of dalbavancin can be described using a three-compartment model.

Table 4. Dalbavancin Pharmacokinetic Parameters in Healthy Subjects Parameter Single 1,000 mg Dose Single 1,500 mg Dose C max (mg/L) 287 (13.9) 1 423 (13.2) 4 AUC 0-24 (mg•h/L) 3,185 (12.8) 1 4,837 (13.7) 4 AUC 0-Day7 (mg•h/L) 11,160 (41.1) 2 ND AUC 0- inf (mg•h/L) 23,443 (40.9) 2 ND Terminal t ½ (h) 346 (16.5) 2,3 ND CL (L/h) 0.0513 (46.8) 2 ND All values are presented as mean (% coefficient of variation) 1 Data from 50 healthy subjects. 2 Data from 12 healthy subjects.

3 Based upon population pharmacokinetic analyses of data from patients, the effective half-life is approximately 8.5 days (204 hours). 4 Data from 49 healthy subjects. Abbreviation: ND – not determined In healthy subjects, dalbavancin AUC 0-24h and C max both increased proportionally to dose following single IV dalbavancin doses ranging from 140 mg to 1,500 mg, indicating linear pharmacokinetics.

No apparent accumulation of dalbavancin was observed following multiple IV infusions administered once weekly for up to eight weeks, with 1000 mg on Day 1 followed by up to seven weekly 500 mg doses, in healthy adults with normal renal function. Distribution Dalbavancin is reversibly bound to human plasma proteins, primarily to albumin. The plasma protein binding of dalbavancin is approximately 93% and is not altered as a function of drug concentration, renal impairment, or hepatic impairment.

The mean concentrations of dalbavancin achieved in skin blister fluid remain above 30 mg/L up to 7 days (approximately 146 hours) post dose, following 1,000 mg IV dalbavancin. The mean ratio of the AUC 0-144 hrs in skin blister fluid/AUC 0-144 hrs in plasma is 0.60 (range 0.44 to 0.64). Metabolism In vitro studies using human microsomal enzymes and hepatocytes indicate that dalbavancin is not a substrate, inhibitor, or inducer of CYP450 isoenzymes.

A minor metabolite of dalbavancin (hydroxy-dalbavancin) has been observed in the urine of healthy subjects. Quantifiable concentrations of the hydroxy-dalbavancin metabolite have not been observed in human plasma (lower limit of quantitation = 0.4 µg/mL) [see Drug Interactions ( 7.2 )] . Excretion Following administration of a single 1,000 mg dose in healthy subjects, 20% of the dose was excreted in feces through 70 days post dose.

An average of 33% of the administered dalbavancin dose was excreted in urine as unchanged dalbavancin and approximately 12% of the administered dose was excreted in urine as the metabolite hydroxy-dalbavancin through 42 days post dose. Specific Populations Renal Impairment The pharmacokinetics of dalbavancin were evaluated in 28 subjects with varying degrees of renal impairment and in 15 matched control subjects with normal renal function. Following a single-dose of 500 mg or 1,000 mg dalbavancin, the mean plasma clearance (CL T ) was reduced 11%, 35%, and 47% in subjects with CLcr 50 to 79 mL/min, CLcr 30 to 49 mL/min, and CLcr less than 30 mL/min, respectively, compared to subjects with normal renal function.

The clinical significance of the decrease in mean plasma CL T , and the associated increase in AUC 0-∞ noted in these pharmacokinetic studies of dalbavancin in subjects with CLcr less than 30 mL/min has not been established [ see Dosage and Administration ( 2.3 ) , Use in Specific Populations ( 8.6 )] . Dalbavancin pharmacokinetic parameters in subjects with end-stage renal disease receiving regularly scheduled hemodialysis (three times/week) are similar to those observed in subjects with mild to moderate renal impairment, and less than 6% of an administered dose is removed after three hours of hemodialysis.

Therefo… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 80 words ▾

12.2Pharmacodynamics The antibacterial activity of dalbavancin appears to best correlate with the ratio of area under the concentration-time curve to minimal inhibitory concentration (AUC/MIC) for Staphylococcus aureus based on animal models of infection. Cardiac Electrophysiology In a randomized, positive- and placebo-controlled, thorough QT/QTc study, 200 healthy subjects received dalbavancin 1,000 mg IV, dalbavancin 1,500 mg IV, oral moxifloxacin 400 mg, or placebo. Neither dalbavancin 1,000 mg nor dalbavancin 1,500 mg had any clinically relevant adverse effect on cardiac repolarization.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Clinical Studies of Dalbavancin for Injection in Adult Patients with Acute Bacterial Skin and Skin Structure Infections Dalbavancin for Injection 1,500 mg Single-Dose Regimen Adult patients with ABSSSI were enrolled in a Phase 3, double-blind, clinical trial. The ITT population included 698 patients who were randomized to dalbavancin for injection treatment with either a single 1,500 mg dose or another dalbavancin dosing regimen (Trial 3). Patients with creatinine clearance less than 30 mL/min had their dose adjusted (Section 2.2 ).

Approximately 5% of patients also received a protocol-specified empiric course of treatment with intravenous aztreonam for coverage of Gram-negative pathogens. The specific infections and other patient characteristics in this trial were similar to those described above for previous ABSSSI trials. The primary endpoint in this ABSSSI trial was the clinical response rate where responders were defined as patients who had at least a 20% decrease from baseline in lesion area 48 to 72 hours after randomization without receiving any rescue antibacterial therapy.

The secondary endpoint was the clinical success rate at a follow-up visit occurring between Days 26 and 30, with clinical success defined as having at least a 90% decrease from baseline in lesion size, a temperature of 37.6°C or lower, and meeting pre-specified criteria for local signs: purulent discharge and drainage absent or mild and improved from baseline (for patients with wound infections), heat/warmth and fluctuance absent, swelling/induration and tenderness to palpation absent or mild. Table 9 summarizes results for these two endpoints in the ITT population.

Note that there are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at the follow-up visit. Therefore, comparisons between treatment groups based on clinical success rates at this visit cannot be utilized to establish non-inferiority. Table 9.

Primary and Secondary Efficacy Results in ABSSSI Patients (Trial 3) 1,2 Dalbavancin for Injection , n/N (%) Single-Dose ( 1,500 mg ) Another Dalbavancin Dosing Regimen Difference (95% CI) 3 Clinical Responders at 48-72 Hours (ITT) 284/349 (81.4) 294/349 (84.2) -2.9 (-8.5, 2.8) Clinical Success at Day 26-30 (ITT) 295/349 (84.5) 297/349 (85.1) -0.6 (-6.0, 4.8) Clinical Success at Day 26-30 (CE) 250/271 (92.3) 247/267 (92.5) -0.3 (-4.9, 4.4) 1 There were 3 patients in another dalbavancin dosing group who did not receive treatment and were counted as non- responders.

2 Patients who died or used non-study antibacterial therapy or had missing measurements were classified as non-responders. 3 The 95% Confidence Interval (CI) is computed using the Miettinen and Nurminen approach. Abbreviations: ITT-intent to treat; CE-clinically evaluable Table 10 shows outcomes in patients with an identified baseline pathogen from Trial 3 in the microbiological ITT (microITT) population.

The outcomes shown in the table are clinical response rates at 48 to 72 hours and clinical success rates at follow-up (Day 26 to 30), as defined above. Table 10. Outcomes by Baseline Pathogen (Trial 3; MicroITT) Early Clinical Response at 48-72 hours ≥ 20 % reduction in lesion size Clinical Success at Day 26 to 30 Pathogen Single-dose (1,500 mg) n/N (% ) Another Dalbavancin Dosing Regimen n/N (%) Single-dose (1,500 mg) n/N (% ) Another Dalbavancin Dosing Regimen n/N (%) Staphylococcus aureus Methicillin-susceptible Methicillin-resistant 123/139 (88.5) 92/103 (89.3) 31/36 (86.1) 133/156 (85.3) 89/96 (89.6) 48/61 (78.7) 124/139 (89.2) 93/103 (90.3) 31/36 (86.1) 140/156 (89.7) 86/96 (89.6) 55/61 (90.2) Streptococcus agalactiae 6/6(100.0) 4/6 (66.7) 5/6 (83.3) 5/6 (83.3) Streptococcus anginosus group 31/33 (93.9) 19/19 (100.0) 29/33 (87.9) 17/19 (89.5) Streptococcus pyogenes 14/14 (100.0) 18/22 (81.8) 13/14 (92.9) 19/22 (86.4) Enterococcus faecalis 4/4 (100.0) 8/10 (80.0) 4/4 (100.0) 9/10 (90.0) In Trial… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals to determine the carcinogenic potential of dalbavancin have not been conducted. Mutagenesis Dalbavancin was not genotoxic in a bacterial reverse mutation (Ames) assay, a mammalian HGPRT gene mutation assay, an in vitro chromosome aberration assay in Chinese Hamster Ovary cells, or an in vivo mouse micronucleus assay. Impairment of Fertility Impaired fertility in the rat was not observed at a dose of 15 mg/kg/day (1.2 times the human dose on an exposure basis).

Reductions in male and female fertility and increased embryo resorptions occurred at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis), at which signs of parental toxicity were also observed .

13.2Animal Toxicology and/or Pharmacology Increases in serum levels of liver enzymes (ALT, AST), associated with microscopic findings in the liver were noted in toxicology studies in rats and dogs where dalbavancin was administered daily for 28 to 90 days. Hepatocellular necrosis was observed in dogs dosed at ≥10 mg/kg/day for longer than 2 months, i.e., at approximately 5 to 7 times the expected human dose on an exposure basis. Histiocytic vacuolation and hepatocyte necrosis were observed in rats dosed daily at 40 and 80 mg/kg/day, respectively, for 4 weeks, (approximately 3 and 6 times the expected human dose on an exposure basis, respectively).

In addition, renal toxicity characterized by increases in serum BUN and creatinine and microscopic kidney findings was observed in rats and dogs at doses 5 to 7 times the expected human dose on an exposure basis. The relationship between these findings in the animal toxicology studies after 28 and 90 consecutive days of dosing to the indicated clinical dosing of 2 doses 7 days apart are unclear.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 120 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals to determine the carcinogenic potential of dalbavancin have not been conducted. Mutagenesis Dalbavancin was not genotoxic in a bacterial reverse mutation (Ames) assay, a mammalian HGPRT gene mutation assay, an in vitro chromosome aberration assay in Chinese Hamster Ovary cells, or an in vivo mouse micronucleus assay. Impairment of Fertility Impaired fertility in the rat was not observed at a dose of 15 mg/kg/day (1.2 times the human dose on an exposure basis).

Reductions in male and female fertility and increased embryo resorptions occurred at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis), at which signs of parental toxicity were also observed .

📄 Package Label / Principal Display Panel 86 words ▾

PRINCIPAL DISPLAY PANEL - Dalbavancin for Injection 500 mg Vial NDC 71288- 034 -50 Rx Only Dalbavancin for Injection 500 mg per vial For Intravenous Infusion Only Sterile Single-Dose Vial Discard Unused Portion PRINCIPAL DISPLAY PANEL - Dalbavancin for Injection 500 mg Vial

PRINCIPAL DISPLAY PANEL - Dalbavancin for Injection 500 mg Carton NDC 71288- 034 -50 Rx Only Dalbavancin for Injection 500 mg per vial For Intravenous Infusion Only Sterile Single-Dose Vial Discard Unused Portion PRINCIPAL DISPLAY PANEL - Dalbavancin for Injection 500 mg Carton

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
34
Units reimbursed last 4 qtrs
102
Gross reimbursed last 4 qtrs
$176.7K
Avg / prescription
$5,197.34
Avg / unit
$1,732.45
Latest quarter Q1 2026
34Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 34 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: 36 units · 0.9 per 100k residents 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: 66 units · 0.5 per 100k residents 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
0.50.9
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 Oregon 0.9 /100k
2 Pennsylvania 0.5 /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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Dalbavancin — the ingredient across all brands.

Top reported reactions

Rash100
Pruritus64
Back Pain61
Dyspnoea59
Vomiting59
Nausea53
Erythema50

Reporter sex

0 reports

Serious outcomes

Death36
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 197 76
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Meitheal Pharmaceuticals Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Meitheal Pharmaceuticals Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J0875 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71288-0033-75 · Meitheal 71288-0035-52 · Meitheal →
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.