Home › NDC Lookup › Ingredients › Micafungin › 42658-0022-02
Micafungin 50 mg Injection, Powder, For Solution — NDC 42658-0022-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Micafungin 50 mg Injection, Powder, For Solution — NDC 42658-022-02 (Billing 42658-0022-02)

by Hisun Pharmaceuticals USA, Inc. · 10 BOX in 1 CARTON / 1 VIAL in 1 BOX / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

This is a package of Micafungin 50 mg Injection, Powder, For Solution from Hisun Pharmaceuticals USA, Inc., marketed since Apr 2026 and currently FDA-listed.

NDC 42658-0022-02
🏷️ FDA NDC (as labeled) 42658-022-02 billing pads the product segment with a zero
This package
Contains1 injection, powder, for solution in 1 vial Pack sizes2 compare ↓
Also priced by: Part D plans $22.33/unit — full pricing hub ↓
Product page 42658-0022-01 Also comes in: 1 vial 42658-022-01
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 →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42658-022-02
Product NDC 42658-022
11-digit billing NDC 42658002202
NCPDP billing unit EA — each (per item)
RxCUI 861379, 861383
UNII IS1UP79R56
UPC 0342658022011, 0342658023018
Application # ANDA219712
SPL Set ID 230fcff4-ad4b-ea25-e063-6394a90a1fab
Established class (EPC) Echinocandin Antifungal
Chemical class Lipopeptides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-01
Route INTRAVENOUS
Dosage form INJECTION, POWDER, FOR SOLUTION
Substance MICAFUNGIN SODIUM
TE code (Orange Book) AP · RLD · RS

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

GPI-14 11500050102120
GCN Seq No 058872
GCN 24397
HICL code 032804
Ingredient (HICL) Micafungin Sodium
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W3
Therapeutic class — intermediate (HIC2) Antimycotics
HIC3 code W3A
Therapeutic class — specific (HIC3) Antifungal Antibiotics
AHFS code 08:14.16.00
AHFS class Echinocandin Antifungals
FDB label name MICAFUNGIN 50 MG VIAL
FDB brand name Micafungin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 058872
  • GCN: 24397
  • GPI-14 (Medi-Span): 11500050102120
  • HICL (First Databank): 032804
  • AHFS class code: 08:14.16.00
  • RxCUI (RxNorm): 861379
Why two NDCs? The FDA registers this code as 42658-022-02 — 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 → 42658-0022-02. 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 Echinocandin Antifungal class.

Pharmacologic class Echinocandin Antifungal
Drug family (ATC) Other antimycotics for systemic use
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 MICAFUNGIN 50 MG VIAL Ingredient Micafungin Sodium
📖 What it is MedlinePlus · NLM

Micafungin is used to treat certain fungal infections that have caused esophagitis ( infection of the throat), spread to the bloodstream, have caused abscesses (collection of pus in body tissue) or caused peritonitis (infection of the lining of the stomach) in adults and children. It is also used to prevent fungal infections in adults and children who have undergone a hematopoietic stem cell transplant (HSCT; procedure in which certain blood cells are removed from the body and then returned to the body). Micafungin is in a class of medications called echinocandins. It works by stopping the bui...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats serious Candida infections, such as those in the bloodstream or esophagus. It also helps prevent Candida infections in people having a stem cell transplant. It is not sho...
  • It goes into a vein as an infusion over about an hour, once a day. A healthcare professional prepares and gives it. Your prescriber decides how long you need it.
  • Diarrhea, nausea, vomiting, belly pain, fever and headache are the most common. Some people get low blood counts or vein irritation at the IV site. Tell your nurse if the site hurt...
  • Get help right away for trouble breathing, facial swelling, or a severe rash, which can signal an allergic reaction. Also report dark or red urine, yellow skin or eyes, or changes...
📖 Read our full Micafungin 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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $22.33 —
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
42658-0022-01 42658-022-01 Main listing 1 VIAL in 1 BOX / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 2026-04-01 — Active
42658-0022-02 You're viewing this 10 BOX in 1 CARTON / 1 VIAL in 1 BOX / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL 2026-04-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 10 box in 1 carton / 1 vial in 1 box / 1 injection, powder, for solution in 1 vial.
What NDC number is used to bill for this package of Micafungin 50 mg Injection, Powder, For Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Micafungin 50 mg 00143-9361-01 Hikma 1 vial — AP FDA listed —
Mycamine 10 mg/mL 00469-3250-10 Astellas 10 vials — — Discontinued —
Micafungin 50 mg/5mL 25021-0190-10 Sagent 1 vial — AP FDA listed —
Micafungin 10 mg/mL 42023-0229-10 Par 10 vials — — Discontinued —
Micafungin 50 mgthis 42658-0022-02 Hisun 1 vial — AP FDA listed —
Micafungin 50 mg 63323-0728-10 Fresenius 1 vial — AP FDA listed —
Micafungin 10 mg/mL 67184-0589-01 Qilu 1 vial — AP FDA listed —
Micafungin 10 mg/mL 68462-0771-01 Glenmark 1 vial — AP FDA listed —
Micafungin 10 mg/mL 70377-0075-91 Biocon 10 vials — AP FDA listed —
Micafungin 10 mg/mL 70710-1724-06 Zydus 10 vials — AP FDA listed —
Micafungin 10 mg/mL 70771-1683-06 Zydus 10 vials — AP FDA listed —
Micafungin 50 mg/5mL 71288-0028-11 Meitheal 10 vials — 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

🏛️
2026
On the market since
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

3 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

LabelerHisun Pharmaceuticals USA, Inc.
Application holderHISUN PHARMACEUTICAL (HANGZHOU) CO LTD
FDA applicationANDA219712 (ANDA)
Labeler code42658
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio9 products on file
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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

Micafungin for Injection is indicated for: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)] . Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)] . Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)] .

Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)] . Limitations of Use The safety and effectiveness of Micafungin for Injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed [see Use in Specific Populations (8.4)] . Micafungin for Injection has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida .

The efficacy of Micafungin for Injection against infections caused by fungi other than Candida has not been established. Micafungin for Injection is an echinocandin indicated in adult and pediatric patients for (1): Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older. Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age.

Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older. Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT). Limitations of Use The safety and effectiveness of Micafungin for Injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed.

(1, 2.3, 8.4) Micafungin for Injection has not been adequately studied in patients with endocarditis, osteomyelitis or meningoencephalitis due to Candida . (1) The efficacy of Micafungin for Injection against infections caused by fungi other than Candida has not been established. (1)

⏱️ Dosage and Administration ~3 min read ▾

Recommended Dosage Administered by Indication, Weight and Age (2.1, 2.2, 2.3, 8.4) Adult Pediatric Patients 4 Months and Older 30 kg or less Pediatric Patients 4 Months and Older greater than 30 kg Pediatric Patients Younger than 4 Months of Age Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses 100 mg daily 2 mg/kg/day (maximum 100 mg daily) See below Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without Meningoencephalitis and/or Ocular Dissemination See above See above 4 mg/kg/day Treatment of Esophageal Candidiasis 150 mg daily 3 mg/kg/day 2.5 mg/kg/day (maximum 150 mg daily) Not approved Prophylaxis of Candida Infections in HSCT Recipients 50 mg daily 1 mg/kg/day (maximum 50 mg daily) Not approved Infuse over 1 hour.

(2.5) See Full Prescribing Information for intravenous (IV) preparation and administration instructions. (2)

2.1Dosage for Adults The recommended dosage for adult patients based on indications are shown in Table 1. Table 1. Micafungin for Injection Dosage in Adult Patients ​​Indication Recommended Reconstituted Dose Once Daily Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses * 100 mg Treatment of Esophageal Candidiasis † 150 mg Prophylaxis of Candida Infections in HSCT Recipients ‡ 50 mg *In patients treated successfully for candidemia and other Candida infections, the mean duration of treatment was 15 days (range 10 to 47 days). † In patients treated successfully for esophageal candidiasis, the mean duration of treatment was 15 days (range 10 to 30 days). ‡ In hematopoietic stem cell transplant (HSCT) recipients who experienced success of prophylactic therapy, the mean duration of prophylaxis was 19 days (range 6 to 51 days).

2.2Dosage for Pediatric Patients 4 Months and Older The recommended dosage for pediatric patients 4 months of age and older based on indication and weight are shown in Table 2. Table 2. Micafungin for Injection Dosage in Pediatric Patients (4 Months of Age and Older) Indication Dosage for Pediatric Patients 4 Months of Age and Older 30 kg or less Greater than 30 kg Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses 2 mg/kg once daily (maximum daily dose 100 mg) Treatment of Esophageal Candidiasis 3 mg/kg once daily 2.5 mg/kg once daily (maximum daily dose 150 mg) Prophylaxis of Candida Infections in HSCT Recipients 1 mg/kg once daily (maximum daily dose 50 mg)

2.3Dosage for Pediatric Patients Younger than 4 Months of Age Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination The recommended dosage is 4 mg/kg once daily. The safety and effectiveness of micafungin for injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed [see Use in Specific Populations (8.4), Clinical Pharmacology (12.3) and Microbiology (12.4)] .

2.4Directions for Reconstitution, Dilution, and Preparation Do not mix or co-infuse micafungin for injection with other medications. Micafungin for injection has been shown to precipitate when mixed directly with a number of other commonly used medications. Please read this entire section carefully before beginning reconstitution.

Reconstitution Reconstitute micafungin for injection vials by aseptically adding 5 mL of one of the following compatible solutions: 0.9% Sodium Chloride Injection, USP (without a bacteriostatic agent) 5% Dextrose Injection, USP To minimize excessive foaming, gently dissolve the micafungin for injection powder by swirling the vial. Do not vigorously shake the vial. Visually inspect the vial for particulate matter.

Micafungin for injection 50 mg vial: after reconstitution each mL contains 10 mg of micafungin. Micafungin for injection 100 mg vial: af… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 41 words ▾

Micafungin for Injection USP is a sterile, white lyophilized cake or powder for reconstitution for intravenous infusion available as: 50 mg single-dose vial 100 mg single-dose vial For injection: 50 mg single-dose vial. (3) For injection: 100 mg single-dose vial. (3)

⛔ Contraindications 44 words ▾

Micafungin for injection is contraindicated in persons with known hypersensitivity to micafungin, any component of micafungin for injection, or other echinocandins. Micafungin for injection is contraindicated in persons with known hypersensitivity to micafungin sodium, any component of micafungin for injection, or other echinocandins. (4)

⚠️ Warnings and Cautions ~2 min read ▾

Hypersensitivity Reactions: Anaphylaxis and anaphylactoid reactions (including shock) have been observed. Discontinue micafungin for injection and administer appropriate treatment. (5.1) Hematological Effects: Isolated cases of acute intravascular hemolysis, hemolytic anemia and hemoglobinuria have been reported.

Monitor rate of hemolysis. Discontinue if severe. (5.2) Hepatic Effects: Abnormalities in liver tests; isolated cases of hepatic impairment, hepatitis, and hepatic failure have been observed.

Monitor hepatic function. Discontinue if severe dysfunction occurs. (5.3) Renal Effects: Elevations in BUN and creatinine; isolated cases of renal impairment or acute renal failure have been reported.

Monitor renal function. (5.4) Infusion and Injection Site Reactions can occur including rash, pruritus, facial swelling, and vasodilatation. Monitor infusion closely, slow infusion rate if necessary.

(2.5, 5.5)

5.1Hypersensitivity Reactions Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported in patients receiving micafungin for injection. If these reactions occur, micafungin for injection infusion should be discontinued and appropriate treatment administered.

5.2Hematological Effects Acute intravascular hemolysis and hemoglobinuria was seen in a healthy volunteer during infusion of micafungin for injection (200 mg) and oral prednisolone (20 mg). Cases of significant hemolysis and hemolytic anemia have also been reported in patients treated with micafungin for injection. Patients who develop clinical or laboratory evidence of hemolysis or hemolytic anemia during micafungin for injection therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing micafungin for injection therapy.

5.3Hepatic Effects Laboratory abnormalities in liver function tests have been seen in healthy volunteers and patients treated with micafungin for injection. In some patients with serious underlying conditions who were receiving micafungin for injection along with multiple concomitant medications, clinical hepatic abnormalities have occurred, and isolated cases of significant hepatic impairment, hepatitis, and hepatic failure have been reported. Patients who develop abnormal liver function tests during micafungin for injection therapy should be monitored for evidence of worsening hepatic function and evaluated for the risk/benefit of continuing micafungin for injection therapy.

5.4Renal Effects Elevations in BUN and creatinine, and isolated cases of significant renal impairment or acute renal failure have been reported in patients who received micafungin for injection. In fluconazole-controlled trials, the incidence of drug-related renal adverse reactions was 0.4% for micafungin for injection-treated patients and 0.5% for fluconazole-treated patients. Patients who develop abnormal renal function tests during micafungin for injection therapy should be monitored for evidence of worsening renal function.

5.5Infusion and Injection Site Reactions Possible histamine-mediated symptoms have been reported with micafungin for injection, including rash, pruritus, facial swelling, and vasodilatation. Slow the infusion rate if infusion reaction occurs [see Dosage and Administration (2.3)] . Injection site reactions, including phlebitis and thrombophlebitis have been reported, at micafungin for injection doses of 50 to 150 mg/day.

These reactions tended to occur more often in patients receiving micafungin for injection via peripheral intravenous administration [see Dosage and Administration (2.3) and Adverse Reactions (6.1)] .

5.1Hypersensitivity Reactions Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported in patients receiving micafungin for injection. If these reactions occur, micafungin for injection infusion should be discontinued and appropriate treatmen… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Hematological Effects [see Warnings and Precautions (5.2)] Hepatic Effects [see Warnings and Precautions (5.3)] Renal Effects [see Warnings and Precautions (5.4)] Infusion and Injection Site Reactions [see Warnings and Precautions (5.5)] Most common adverse reactions across adult and pediatric clinical trials for all indications include diarrhea, nausea, vomiting, abdominal pain, pyrexia, thrombocytopenia, neutropenia, and headache.

(6.1) In pediatric patients younger than 4 months of age, the following additional common adverse reactions were reported at an incidence rate of ≥15%: sepsis, acidosis, anemia, oxygen saturation decreased and hypokalemia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Hisun Pharmaceuticals USA, Inc. at 1-855-554-4786 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 micafungin for injection cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. The overall safety of micafungin for injection was assessed in 520 healthy volunteers and 3417 adult and pediatric patients who received single or multiple doses of micafungin for injection across 50 clinical trials, including the invasive candidiasis, esophageal candidiasis and prophylaxis trials.

The doses of micafungin for injection administered included doses above and below the recommended doses [see Dosage and Administration (2.1, 2.2)] and ranged from 0.75 mg/kg to 15 mg/kg in pediatric patients and 12.5 mg to 150 mg/day or greater in adults. Clinical Trials Experience in Adults In clinical trials with micafungin for injection, 2497/2748 (91%) adult patients experienced at least one adverse reaction. Candidemia and Other Candida Infections In a randomized, double-blind trial for the treatment of candidemia and other Candida infections, adverse reactions occurred in 183/200 (92%) and 171/193 (89%) patients in the micafungin for injection 100 mg/day, and caspofungin (70 mg loading dose followed by 50 mg/day dose) treatment groups, respectively.

Selected adverse reactions occurring in 5% or more of the patients and more frequently in the micafungin for injection treatment group, are shown in Table 3. Table 3. Selected * Adverse Reactions in Adult Patients with Candidemia and Other Candida Infections Adverse Reactions by System Organ Class † Micafungin for Injection 100 mg n (%) Caspofungin ‡ n (%) Number of Patients 200 193 Gastrointestinal Disorders 81 (41) 76 (39) Diarrhea 15 (8) 14 (7) Vomiting 18 (9) 16 (8) Metabolism and Nutrition Disorders 77 (39) 73 (38) Hypoglycemia 12 (6) 9 (5) Hyperkalemia 10 (5) 5 (3) General Disorders/Administration Site Conditions 59 (30) 51 (26) Investigations 36 (18) 37 (19) Blood Alkaline Phosphatase Increased 11 (6) 8 (4) Cardiac Disorders 35 (18) 36 (19) Atrial Fibrillation 5 (3) 0 Patient base: all randomized patients who received at least 1 dose of trial drug. * During IV treatment + 3 days. † Within a system organ class, patients may experience more than 1 adverse reaction. ‡ 70 mg loading dose on day 1 followed by 50 mg/day thereafter (caspofungin).

In a second, supportive, randomized, double-blind trial for the treatment of candidemia and other Candida infections, adverse reactions occurred in 245/264 (93%) and 250/265 (94%) adult and pediatric patients in the micafungin for injection (100 mg/day) and amphotericin B liposome (3 mg/kg/day) treatment groups, respectively. In this trial, the following adverse reactions were reported in patients at least 16 years of age in the micafungin for injection and amphotericin B liposome treatment groups, respectively: nausea (10% vs.

8%), diarrhea (11% vs. 11%), vomiting (13% vs. 9%), abnorma… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

Monitor for sirolimus, itraconazole or nifedipine toxicity, and dosage of sirolimus, itraconazole or nifedipine should be reduced, if necessary. (7)

7.1Effect of Other Drugs on Micafungin for Injection CYP3A4, CYP2C9 and CYP2C19 Inhibitors Co-administration of micafungin for injection with cyclosporine, itraconazole, voriconazole and fluconazole did not alter the pharmacokinetics of micafungin for injection. CYP2C19 and CYP3A4 Inducer Co-administration of micafungin for injection with rifampin and ritonavir did not alter the pharmacokinetics of micafungin for injection. Co-administration of Micafungin for Injection with Other Drugs Co-administration of micafungin for injection with mycophenolate mofetil (MMF), amphotericin B, tacrolimus, prednisolone, sirolimus and nifedipine did not alter the pharmacokinetics of micafungin for injection.

7.2Effect of Micafungin for Injection on Other Drug CYP3A4 Substrates There was no effect of single or multiple doses of micafungin for injection on cyclosporine, tacrolimus, prednisolone, voriconazole and fluconazole pharmacokinetics. Sirolimus AUC was increased by 21% with no effect on C max in the presence of steady-state micafungin for injection compared with sirolimus alone. Nifedipine AUC and C max were increased by 18% and 42%, respectively, in the presence of steady-state micafungin for injection compared with nifedipine alone.

Itraconazole AUC and C max were increased by 22% and 11%, respectively. Patients receiving sirolimus, nifedipine, and itraconazole in combination with micafungin for injection should be monitored for sirolimus, nifedipine, and itraconazole toxicity and the sirolimus, nifedipine, and itraconazole dosage should be reduced if necessary. UDP-Glycosyltransferase Substrate Co-administration of mycophenolate mofetil (MMF) with micafungin for injection did not alter the pharmacokinetics of MMF.

7.1Effect of Other Drugs on Micafungin for Injection CYP3A4, CYP2C9 and CYP2C19 Inhibitors Co-administration of micafungin for injection with cyclosporine, itraconazole, voriconazole and fluconazole did not alter the pharmacokinetics of micafungin for injection. CYP2C19 and CYP3A4 Inducer Co-administration of micafungin for injection with rifampin and ritonavir did not alter the pharmacokinetics of micafungin for injection. Co-administration of Micafungin for Injection with Other Drugs Co-administration of micafungin for injection with mycophenolate mofetil (MMF), amphotericin B, tacrolimus, prednisolone, sirolimus and nifedipine did not alter the pharmacokinetics of micafungin for injection.

7.2Effect of Micafungin for Injection on Other Drug CYP3A4 Substrates There was no effect of single or multiple doses of micafungin for injection on cyclosporine, tacrolimus, prednisolone, voriconazole and fluconazole pharmacokinetics. Sirolimus AUC was increased by 21% with no effect on C max in the presence of steady-state micafungin for injection compared with sirolimus alone. Nifedipine AUC and C max were increased by 18% and 42%, respectively, in the presence of steady-state micafungin for injection compared with nifedipine alone.

Itraconazole AUC and C max were increased by 22% and 11%, respectively. Patients receiving sirolimus, nifedipine, and itraconazole in combination with micafungin for injection should be monitored for sirolimus, nifedipine, and itraconazole toxicity and the sirolimus, nifedipine, and itraconazole dosage should be reduced if necessary. UDP-Glycosyltransferase Substrate Co-administration of mycophenolate mofetil (MMF) with micafungin for injection did not alter the pharmacokinetics of MMF.

👥 Use in Specific Populations ~3 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies, micafungin for injection may cause fetal harm when administered to a pregnant woman (see Data) . There is insufficient human data on the use of micafungin for injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, intravenous administration of micafungin sodium to pregnant rabbits during organogenesis at doses four times the maximum recommended human dose resulted in visceral abnormalities and increased abortion (see Data) .

Advise pregnant women of the risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations 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 In an embryo-fetal toxicity study in pregnant rabbits, intravenous administration of micafungin sodium during organogenesis (days 6 to 18 of gestation) resulted in fetal visceral abnormalities and abortion at 32 mg/kg, a dose equivalent to four times the recommended human dose based on body surface area comparisons. Visceral abnormalities included abnormal lobation of the lung, levocardia, retrocaval ureter, anomalous right subclavian artery, and dilatation of the ureter.

8.2Lactation Risk Summary There are no data on the presence of micafungin in human milk, the effects on the breast-fed infant or the effects on milk production. Micafungin was present in the milk of lactating rats following intravenous administration. 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 micafungin for injection, and any potential adverse effects on the breast-fed child from micafungin for injection, or from the underlying maternal condition.

8.4Pediatric Use Pediatric Patients 4 Months of Age and Older The safety and effectiveness of micafungin for injection for the treatment of esophageal candidiasis, candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and for prophylaxis of Candida infections in patients undergoing HSCT have been established in pediatric patients 4 months of age and older. Use of micafungin for injection for these indications and in this age group is supported by evidence from adequate and well-controlled studies in adult and pediatric patients with additional pharmacokinetic and safety data in pediatric patients 4 months of age and older [see Indications and Usage (1), Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)] .

Pediatric Patients Younger than 4 Months of Age Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses Without Meningoencephalitis and/or Ocular Dissemination in Pediatric Patients Younger Than 4 Months of Age The safety and effectiveness of micafungin for injection for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination at a dosage of 4 mg/kg once daily have been established in pediatric patients younger than 4 months of age.

This use and dosage of micafungin for injection are supported by evidence from adequate and well-controlled studies in adult and pediatric patients 4 months of age and older with additional pharmacokinetic and safety data in pediatric patients younger than 4 months of age [see Adverse Reactions (6.1) and Clinical Pharmacology (12.3)] . Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses With Meningoencephalitis and/or Ocular Dissemination in Pediatric Patients Younger Than 4 Month… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 87 words ▾

Micafungin for injection is highly protein bound and, therefore, is not dialyzable. No cases of micafungin for injection overdosage have been reported. Repeated daily doses up to 8 mg/kg (maximum total dose of 896 mg) in adult patients, up to 6 mg/kg in pediatric patients 4 months of age and older, and up to 15 mg/kg in pediatric patients younger than 4 months of age have been administered in clinical trials with no reported dose-limiting toxicity [see Adverse Reactions (6.1) and Use in Specific Populations (8.4)] .

🧬 Clinical Pharmacology ~3 min read ▾

12.1Mechanism of Action Micafungin is a member of the echinocandin class of antifungal agents [see Microbiology (12.4)] .

12.2Pharmacodynamics The pharmacodynamics of micafungin related to hematogenous Candida meningoencephalitis are described in other sections of the prescribing information [see Use in Specific Populations (8.4) and Microbiology (12.4)] .

12.3Pharmacokinetics Adults The pharmacokinetics of micafungin were determined in healthy subjects, hematopoietic stem cell transplant recipients, and patients with esophageal candidiasis up to a maximum daily dose of 8 mg/kg body weight. The relationship of area under the concentration-time curve (AUC) to micafungin dose was linear over the daily dose range of 50 mg to 150 mg and 3 mg/kg to 8 mg/kg body weight. Typically, 85% of the steady-state concentration is achieved after three daily micafungin for injection doses.

Steady-state pharmacokinetic parameters in relevant patient populations after repeated daily administration are presented in Table 7. Table 7. Pharmacokinetic Parameters of Micafungin in Adult Patients Population n Dose (mg) Pharmacokinetic Parameters (Mean ± Standard Deviation) C max (mcg/mL) AUC 0-24 * (mcg·h/mL) t ½ (h) Cl (mL/min/kg) Patients with IC † [Day 1] 20 100 5.7 ± 2.2 83 ± 51 14.5 ± 7.0 0.359 ± 0.179 [Steady-State] 20 100 10.1 ± 4.4 97 ± 29 13.4 ± 2.0 0.298 ± 0.115 HIV ‡ - Positive Patients with EC § [Day 1] 20 50 4.1 ± 1.4 36 ± 9 14.9 ± 4.3 0.321 ± 0.098 20 100 8.0 ± 2.4 108 ± 31 13.8 ± 3.0 0.327 ± 0.093 14 150 11.6 ± 3.1 151 ± 45 14.1 ± 2.6 0.340 ± 0.092 [Day 14 or 21] 20 50 5.1 ± 1.0 54 ± 13 15.6 ± 2.8 0.300 ± 0.063 20 100 10.1 ± 2.6 115 ± 25 16.9 ± 4.4 0.301 ± 0.086 14 150 16.4 ± 6.5 167 ± 40 15.2 ± 2.2 0.297 ± 0.081 HSCT ¶ Recipients [Day 7] per kg 8 3 21.1 ± 2.84 234 ± 34 14.0 ± 1.4 0.214 ± 0.031 10 4 29.2 ± 6.2 339 ± 72 14.2 ± 3.2 0.204 ± 0.036 8 6 38.4 ± 6.9 479 ± 157 14.9 ± 2.6 0.224 ± 0.064 8 8 60.8 ± 26.9 663 ± 212 17.2 ± 2.3 0.223 ± 0.081 * AUC 0-infinity is presented for Day 1; AUC 0-24 is presented for steady-state. † candidemia or other Candida infections. ‡ human immunodeficiency virus. § esophageal candidiasis. ¶ hematopoietic stem cell transplant.

Pediatric Patients 4 Months of Age and Older Micafungin pharmacokinetics in 229 pediatric patients 4 months through 16 years of age were characterized using population pharmacokinetics. Micafungin exposure was dose proportional across the dose and age range studied. Table 8.

Summary (Mean +/- Standard Deviation) of Micafungin Pharmacokinetics in Pediatric Patients 4 Months of Age and Older (Steady-State) Body weight group N Dose * mg/kg C max.ss † (mcg/mL) AUC .ss † (mcg·h/mL) t½ ‡ (h) CL ‡ (mL/min/kg) 30 kg or less 149 1.0 7.1 +/- 4.7 55 +/- 16 12.5 +/- 4.6 0.328 +/- 0.091 2.0 14.2 +/- 9.3 109 +/- 31 3.0 21.3 +/- 14.0 164 +/- 47 Greater than 30 kg 80 1.0 8.7 +/- 5.6 67 +/- 17 13.6 +/- 8.8 0.241 +/- 0.061 2.0 17.5 +/- 11.2 134 +/- 33 2.5 23.0 +/- 14.5 176 +/- 42 * Or the equivalent if receiving the adult dose (50, 100, or 150 mg). † Derived from simulations from the population PK model. ‡ Derived from the population PK model.

Pediatric Patients Younger than 4 Months of Age Micafungin pharmacokinetic data in 103 pediatric patients less than 4 months of age were assessed using population pharmacokinetics. Predicted micafungin AUC estimates were dose proportional across the dose regimens and age ranges studied. The body weight-normalized micafungin clearance in pediatric patients less than 4 months of age is higher than the body weight-normalized micafungin clearance in older pediatric patients greater than 4 months of age and adults.

Administration of 4 mg/kg once daily micafungin to pediatric patients less than 4 months of age produces a mean (SD) steady-state AUC of 131 (50) mcg·h/mL, which is comparable to the steady-state AUC in pediatric patients 4 months of age and older administered micafungin 2 mg/kg/day and adults administered 100 mg once daily. Specific Populations Adult Pa… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 148 words ▾

Micafungin for Injection USP is supplied as a sterile, white lyophilized cake or powder for reconstitution for intravenous infusion, and is available in the following packaging configurations: NDC 42658-022-01, 50 mg single-dose vials, sealed with a green flip-off cap, packaged individually. NDC 42658-022-02, Cartons of 10 individually packaged 50 mg single-dose vials, sealed with a green flip-off cap. NDC 42658-023-01, 100 mg single-dose vials, sealed with a purple flip-off cap, packaged individually.

NDC 42658-023-02, Cartons of 10 individually packaged 100 mg single-dose vials, sealed with a purple flip-off cap. Storage Unopened vials of lyophilized material must be stored at 20˚C to 25˚C (68˚F to 77˚F); excursions permitted to 15˚C to 30˚C (59˚F to 86˚F) [see USP Controlled Room Temperature]. Store the reconstituted product at 25˚C (77˚F) [see Dosage and Administration (2.4)] .

Store the diluted solution at 25˚C (77˚F) [see Dosage and Administration (2.4)] . Protect from light.

📋 Description ~1 min read ▾

Micafungin for Injection USP is a sterile, lyophilized product for intravenous (IV) infusion that contains Micafungin Sodium USP. Micafungin Sodium USP is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall.

Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg Micafungin Sodium USP) or 100 mg micafungin (equivalent to 101.73 mg Micafungin Sodium USP), 200 mg lactose monohydrate, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for Injection USP must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration (2)] . Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5-7.

Micafungin Sodium USP is chemically designated as: Pneumocandin A0,1-[(4 R ,5 R )-4,5-dihydroxy- N 2 -[4-[5-[4-(pentyloxy) phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4 S )4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of Micafungin Sodium USP is: The empirical/molecular formula is C 56 H 70 N 9 NaO 23 S and the formula weight is 1292.26. Micafungin Sodium USP is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane.

Micafungin_Sodium_Version 03 US 5kg 20240416

🔬 Clinical Studies ~3 min read ▾

14.1Treatment of Candidemia and Other Candida Infections in Adult and Pediatric Patients 4 Months of Age and Older Two dose levels of micafungin for injection were evaluated in a randomized, double-blind study to determine the efficacy and safety versus caspofungin in patients with invasive candidiasis and candidemia. Patients were randomized to receive once daily intravenous infusions (IV) of micafungin for injection, either 100 mg/day or 150 mg/day or caspofungin (70 mg loading dose followed by 50 mg maintenance dose).

Patients in both study arms were permitted to switch to oral fluconazole after at least 10 days of intravenous therapy, provided they were non-neutropenic, had improvement or resolution of clinical signs and symptoms, had a Candida isolate which was susceptible to fluconazole, and had documentation of 2 negative cultures drawn at least 24 hours apart. Patients were stratified by APACHE II score (20 or less or greater than 20) and by geographic region. Patients with Candida endocarditis were excluded from this analysis.

Outcome was assessed by overall treatment success based on clinical (complete resolution or improvement in attributable signs and symptoms and radiographic abnormalities of the Candida infection and no additional antifungal therapy) and mycological (eradication or presumed eradication) response at the end of IV therapy. Deaths that occurred during IV study drug therapy were treated as failures. In this study, 111/578 (19.2%) of the patients had baseline APACHE II scores of greater than 20, and 50/578 (8.7%) were neutropenic at baseline (absolute neutrophil count less than 500 cells/mm 3 ).

Outcome, relapse and mortality data are shown for the recommended dose of micafungin for injection (100 mg/day) and caspofungin in Table 9. Table 9. Efficacy Analysis: Treatment Success in Patients in Study 03-0-192 with Candidemia and Other Candida Infections Micafungin for Injection 100 mg/day n (%) % treatment difference (95% CI) Caspofungin 70/50 mg/day * n (%) Treatment Success at End of IV Therapy † 135/191 (70.7) 7.4 (-2.0, 16.3) 119/188 (63.3) Success in Patients with Neutropenia at Baseline 14/22 (63.6) 5/11 (45.5) Success by Site of Infection Candidemia 116/163 (71.2) 103/161 (64) Abscess 4/5 (80) 5/9 (55.6) Acute Disseminated ‡ 6/13 (46.2) 5/9 (55.6) Endophthalmitis 1/3 1/1 Chorioretinitis 0/3 0 Skin 1/1 0 Kidney 2/2 1/1 Pancreas 1/1 0 Peritoneum 1/1 0 Lung/Skin 0/1 0 Lung/Spleen 0/1 0 Liver 0 0/2 Intraabdominal abscess 0 3/5 Chronic Disseminated 0/1 0 Peritonitis 4/6 (66.7) 2/5 (40) Success by Organism § C. albicans 57/81 (70.4) 45/73 (61.6) C. glabrata 16/23 (69.6) 19/31 (61.3) C. tropicalis 17/27 (63) 22/29 (75.9) C. parapsilosis 21/28 (75) 22/39 (56.4) C. krusei 5/8 (62.5) 2/3 (66.7) C. guilliermondii 1/2 0/1 C. lusitaniae 2/3 (66.7) 2/2 Relapse through 6 Weeks ¶ Overall 49/135 (36.3) 44/119 (37) Culture-confirmed relapse 5 4 Required systemic antifungal therapy 11 5 Died during follow-up 17 16 Not assessed 16 19 Overall study mortality 58/200 (29) 51/193 (26.4) Mortality during IV therapy 28/200 (14) 27/193 (14) * 70 mg loading dose on day 1 followed by 50 mg/day thereafter (caspofungin). † All patients who received at least one dose of study medication and had documented invasive candidiasis or candidemia.

Patients with Candida endocarditis were excluded from the analyses. ‡ A patient may have had greater than 1 organ of dissemination. § A patient may have had greater than 1 baseline infection species. ¶ All patients who had a culture-confirmed relapse or required systemic antifungal therapy in the post-treatment period for a suspected or proven Candida infection. Also includes patients who died or were not assessed in follow-up. In two cases of ophthalmic involvement assessed as failures in the above table due to missing evaluation at the end of IV treatment with micafungin for injection, therapeutic success was documented during protocol-defined oral fluconazole therapy.

14.2Treatment of E… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence 20 words ▾

There has been no evidence of either psychological or physical dependence or withdrawal or rebound effects with micafungin for injection.

🧪 Nonclinical Toxicology 118 words ▾

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2Animal Toxicology and/or Pharmacology High doses of micafungin sodium (5 to 8 times the highest recommended human dose, based on AUC comparisons) have been associated with irreversible changes to the liver when administered for 3 or 6 months, and these changes may be indicative of pre-malignant processes [see Nonclinical Toxicology (13.1)] .

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2Animal Toxicology and/or Pharmacology High doses of micafungin sodium (5 to 8 times the highest recommended human dose, based on AUC comparisons) have been associated with irreversible changes to the liver when administered for 3 or 6 months, and these changes may be indicative of pre-malignant processes [see Nonclinical Toxicology (13.1)] .

📄 Package Label / Principal Display Panel 78 words ▾

NDC 42658-022-01 Vial Label Micafungin for injection, USP 50 mg per vial NDC 42658-023-01 Vial Label Micafungin for injection, USP 100 mg per vial NDC 42658-022-01 Inner carton Micafungin for injection, USP 50 mg per vial NDC 42658-023-01 Inner carton Micafungin for injection, USP 100 mg per vial NDC 42658-022-02 Outer carton Micafungin for injection, USP 50 mg per vial NDC 42658-023-02 Outer carton Micafungin for injection, USP 100 mg per vial 11411-draft-vial-label-50mg-10-pack 11411-draft-vial-label-100mg-10-pack 11411-draft-inner-carton-50mg-sdv 11411-draft-inner-carton-100mg-sdv 11411-draft-outer-carton-50mg-10-pack 11411-draft-outer-carton-100mg-10-pack

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Micafungin — the program that covers self-administered drugs. 9 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Micafungin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.03M
Claims incl. refills
5.1K
Beneficiaries
1.6K
Spend / beneficiary
$1,280.10
Spend / claim
$399.51
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Hisun Pharmaceuticals USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (42658-0022-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Hisun Pharmaceuticals USA, 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.
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.
← 42658-0021-01 · Hisun 42658-0023-01 · Hisun →
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.