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Micafungin 10 mg/mL Injection, Powder, Lyophilized, For Solution — NDC 42023-229-10 (Billing 42023-0229-10)

by Par Health USA, LLC · 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

This is a package of Micafungin 10 mg/mL Injection, Powder, Lyophilized, For Solution from Par Health USA, LLC, no longer marketed (first marketed Aug 2021), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 42023-0229-10
🏷️ FDA NDC (as labeled) 42023-229-10 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ On shortage ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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

NDC database record

One package, one record: these facts belong to NDC 42023-229-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
42023 labeler · 229 product · 10 package
Package marketed since
Aug 1, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4202322910 6
Medicaid fills, this package
13 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Active FDA shortage. Micafungin Sodium Injection is currently reported in shortage by the FDA. Shortage details →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42023-229-10
Product NDC 42023-229
11-digit billing NDC 42023022910
NCPDP billing unit EA — each (per item)
RxCUI 861379, 861383
UNII IS1UP79R56
Application # NDA212156
SPL Set ID 70b3f044-95ca-4503-b669-ed39972592b6
Established class (EPC) Echinocandin Antifungal
Chemical class Lipopeptides
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2025)
Marketing start 2021-08-01
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance MICAFUNGIN SODIUM

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

GPI-14 11500050102120
GPI class Micafungin Sodium
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 42023-229-10 — 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 → 42023-0229-10. 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 $90.72 $9,072.00 / 100 ml
Medicare drug plans payPart D · Q2 2026 $22.33 $2,232.83 / 100 ml
Medicare Part B allowsASP · J2247 $0.219 / J2247 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)42023-229-10
11-digit billing NDC42023-0229-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2247
DescriptorINJECTION, MICAFUNGIN SODIUM (PAR PHARM) NOT THEREAPEUTICALLY EQUIVALENT TO J2248, 1 MG
Billing units / pkg50 units
How the units are derivedThis package is 10 EA; the HCPCS unit is 1 MG, so one package = 50 billing units.
Medicare Part B spend (2026 (Q1))$819 · 39 claims · $21.00 per claim (all NDCs under J2247)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
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
42023-0229-10 You're viewing this Main listing 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE 2021-08-01 — Discontinued by firm

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/mLthis 42023-0229-10 Par 10 vials — — Discontinued —
Micafungin 50 mg 42658-0022-01 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 the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2021
On the market since
Aug 2021
📍
2026
Currently FDA-listed
5 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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 Micafungin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerPar Health USA, LLC
Application holderPH HEALTH LTD
FDA applicationNDA212156 (NDA)
Labeler code42023
First marketedAug 2021
Product typeHuman Prescription Drug
Portfolio219 products on file

More NDCs from Par Health USA, LLC labeler code 42023

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE 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 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 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. Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Mycamine ® (micafungin for injection).

However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Micafungin for Injection is an echinocandin indicated in adult and pediatric patients for: Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older. ( 1 ) Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older.

( 1 ) Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT). ( 1 ) Limitations of Use 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 ▾

2 DOSAGE AND ADMINISTRATION R eco m m e nd e d Dosage Administered by Indication, Weight and Age ( 2.1 , 2.2 , 8.4 ) Adult Pediatric Patients 4 Months and Older 30 kg or less Pediatric Patients 4 Months and Older greater than 30 kg Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses 100 mg daily 2 mg/kg/day (maximum 100 mg daily) Treatment of Esophageal Candidiasis 150 mg daily 3 mg/kg/day 2.5 mg/kg/day (maximum 150 mg daily) Prophylaxis of Candida Infections in HSCT Recipients 50 mg daily 1 mg/kg/day (maximum 50 mg daily) Infuse over 1 hour.

( 2.4 ) 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. T able 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 C andida Infections in HSCT Recipients 1 mg/kg once daily (maximum daily dose 50 mg) Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Mycamine ® (micafungin for injection).

However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

2.3Directions for Reconstitution, Dilution, Preparation and Storage 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.

R econstitution 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 : after reconstitution each mL contains 20 mg of micafungin. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not use material if there is any evidence of precipitation or foreign matter. Aseptic technique must be strictly observed in all handling since no preservative or bacteriostatic agent is present in Micafungin for Injection or in the materials specified for reconstitution and dilution. The reconstituted product should be protected from light and… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 47 words ▾

3 DOSAGE FORMS AND STRENGTHS Micafungin for Injection is a sterile, white lyophilized 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 48 words ▾

4 CONTRAINDICATIONS 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 ▾

5 WARNINGS AND PRECAUTIONS 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.

( 2.4 , 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 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 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 ( 2.4 )] . 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 ( 2.4 ) and Adverse Reactions ( 6.1 )] .

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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 ) To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 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 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 3227 adult and pediatric patients who received single or multiple doses of micafungin for injection across 46 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 10 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. C andidemia and Other Candida Infections In a randomized, double-blind trial for 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. T able 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 (%) C aspofungin § n (%) N umber of Patients 200 193 G astrointestinal 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) G eneral Disorders/Administration Site Conditions 59 (30) 51 (26) I nvestigations 36 (18) 37 (19) Blood Alkaline Phosphatase Increased 11 (6) 8 (4) C ardiac 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%), abnormal liver tests (4% vs. 3%); increased aspartate aminotransferase (3% vs. 2%), and increased blood alkaline phosphatase (3% vs.

2%). E s ophageal Candidiasis In a randomized, double-blind study for treatment of esophageal c… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS 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. CYP2C19 and CYP3A4 Inducer Co-administration of micafungin for injection with rifampin and ritonavir did not alter the pharmacokinetics of micafungin. Co-administration of Micafungin 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 Drugs 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 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 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, Micafungin for Injection may cause fetal harm. Advise pregnant women of the risk to the fetus. ( 8.1 )

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 visceral abnormalities and abortion at 32 mg/kg, a dose equivalent to about four times the recommended 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 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. In a rabbit model of hematogenous Candida meningoencephalitis (HCME) with Candida albicans (minimum inhibitory concentration of 0.125 mcg/mL), a decrease in mean fungal burden in central nervous system (CNS) compartments assessed as the average of combined fungal burden in the cerebrum, cerebellum, and spinal cord relative to untreated controls, was observed with increasing micafungin dosages administered once daily for 7 days.

In this rabbit model, micafungin concentrations could not be reliably detected in cerebrospinal fluid (CSF). Due to limitations of the study design, the clinical significance of a decreased CNS fungal burden in the rabbit H… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 219 words ▾

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 visceral abnormalities and abortion at 32 mg/kg, a dose equivalent to about four times the recommended 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.

🧒 Pediatric Use ~2 min read ▾

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 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. In a rabbit model of hematogenous Candida meningoencephalitis (HCME) with Candida albicans (minimum inhibitory concentration of 0.125 mcg/mL), a decrease in mean fungal burden in central nervous system (CNS) compartments assessed as the average of combined fungal burden in the cerebrum, cerebellum, and spinal cord relative to untreated controls, was observed with increasing micafungin dosages administered once daily for 7 days.

In this rabbit model, micafungin concentrations could not be reliably detected in cerebrospinal fluid (CSF). Due to limitations of the study design, the clinical significance of a decreased CNS fungal burden in the rabbit HCME model is uncertain. The safety and effectiveness of micafungin for injection in pediatric patients younger than 4 months of age have not been established for the: Treatment of esophageal candidiasis Prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Mycamine ® (micafungin for injection).

However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information .

🧓 Geriatric Use 124 words ▾

8.5Geriatric Use A total of 418 subjects in clinical studies of micafungin for injection were 65 years of age and older, and 124 subjects were 75 years of age and older. No overall differences in safety and effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

The exposure and disposition of a 50 mg micafungin for injection dose administered as a single 1-hour infusion to 10 healthy subjects aged 66 to 78 years were not significantly different from those in 10 healthy subjects aged 20 to 24 years. No dose adjustment is necessary for the elderly.

🆘 Overdosage 120 words ▾

10 OVERDOSAGE 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 10 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 )] .

Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Mycamine ® (micafungin for injection). However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

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. T able 7. Pharmacokinetic Parameters of Micafungin in Adult Patients P opulation n D ose (m g ) P harmacokinetic Parameters ( Mean ± Standard Deviation) C m a x (m c g/mL) AUC 0-24* (m c g·h/mL) t 1/2 ( h) Cl (m L/ m i n/kg) Patients with IC † [Day 1] [Steady State] 20 20 100 100 5.7±2.2 10.1±4.4 83±51 97±29 14.5±7.0 13.4±2.0 0.359 ±0.179 0.298 ±0.115 HIV ‡ - Positive Patients with EC § [Day 1] [Day 14 or 21] 20 20 14 20 20 14 50 100 150 50 100 150 4.1±1.4 8.0±2.4 11.6±3.1 5.1±1.0 10.1±2.6 16.4±6.5 36±9 108±31 151±45 54±13 115±25 167±40 14.9±4.3 13.8±3.0 14.1±2.6 15.6±2.8 16.9±4.4 15.2±2.2 0.321 ±0.098 0.327 ±0.093 0.340 ±0.092 0.300±0.063 0.301±0.086 0.297±0.081 HSCT ¶ Recipients [Day 7] 8 10 8 8 per kg 3 4 6 8 21.1±2.84 29.2±6.2 38.4±6.9 60.8±26.9 234±34 339±72 479±157 663±212 14.0±1.4 14.2±3.2 14.9±2.6 17.2±2.3 0.214±0.031 0.204±0.036 0.224±0.064 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) B ody weight group N D ose* m g/kg C m a x .ss † (m c g/mL) AUC .ss † (m c g·h /mL) t 1/2 ‡ ( h) CL ‡ (m L/ m i n/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.

Specific Populations Adult Patients with Renal Impairment Micafungin for injection does not require dose adjustment in patients with renal impairment. A single 1-hour infusion of 100 mg micafungin for injection was administered to 9 adult subjects with severe renal impairment (creatinine clearance less than 30 mL/min) and to 9 age-, gender-, and weight-matched subjects with normal renal function (creatinine clearance greater than 80 mL/min). The maximum concentration (C max ) and AUC were not significantly altered by severe renal impairment.

Since micafungin is highly protein bound, it is not dialyzable. Supplementary dosing should not be required following hemodialysis. Adult Patients with Hepatic Impairment A single 1-hour infusion of 100 mg micafungin for injection was administered to 8 adult subjects with moderate hepatic impairment (Child-Pugh score 7 to 9) and 8 age-, gender-,… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 21 words ▾

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

📦 How Supplied / Storage and Handling 114 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Micafungin for Injection is supplied as a sterile, white lyophilized powder for reconstitution for intravenous infusion, and is available in the following packaging configurations: NDC 42023-229-10: 50 mg single-dose vials supplied in packages of 10 NDC 42023-230-10: 100 mg single-dose vials supplied in packages of 10 The vial stopper is not manufactured with natural rubber latex. Storage Store Micafungin for Injection, for intravenous use at room temperature, 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].

Store the reconstituted product at 25°C (77°F) [see Dosage and Administration ( 2.3 )]. Store the diluted solution at 25°C (77°F) [see Dosage and Administration ( 2.3 )]. Protect from light.

📋 Description ~1 min read ▾

11 DESCRIPTION Micafungin for injection is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium 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) and 200 mg sucrose or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium) and 400 mg sucrose, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for injection must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration ( 2.3 )] . Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 4.5 to 7.0.

Micafungin sodium 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 is: The empirical/molecular formula is C 56 H 70 N 9 NaO 23 S and the formula weight is 1292.26. Micafungin sodium 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 structural formula

💬 Information for Patients 179 words ▾

17 PATIENT COUNSELING INFORMATION Hypersensitivity Inform patients about the serious adverse effects of Micafungin for Injection including hypersensitivity reactions e.g., anaphylaxis and anaphylactoid reactions including shock. Hepatic Inform patients about the serious adverse effects of Micafungin for Injection including hepatic effects e.g., abnormal liver tests, hepatic impairment, hepatitis or worsening hepatic failure. Hematologic Inform patients about the serious adverse effects of Micafungin for Injection including hematological effects e.g., acute intravascular hemolysis, hemolytic anemia and hemoglobinuria.

Renal Inform patients about the serious adverse effects of Micafungin for Injection including renal effects e.g., elevations in BUN and creatinine, renal impairment or acute renal failure. Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk of Micafungin for Injection to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy.

Concomitant Medications Instruct patients to inform their healthcare provider of any other medications they are currently taking with Micafungin for Injection, including over-the-counter medications. Manufactured for: Par Health USA Rochester, MI 48307 © 2026 Par Health, Inc. or one of its affiliates. R07/2026

🧬 Pharmacokinetics ~3 min read ▾

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. T able 7. Pharmacokinetic Parameters of Micafungin in Adult Patients P opulation n D ose (m g ) P harmacokinetic Parameters ( Mean ± Standard Deviation) C m a x (m c g/mL) AUC 0-24* (m c g·h/mL) t 1/2 ( h) Cl (m L/ m i n/kg) Patients with IC † [Day 1] [Steady State] 20 20 100 100 5.7±2.2 10.1±4.4 83±51 97±29 14.5±7.0 13.4±2.0 0.359 ±0.179 0.298 ±0.115 HIV ‡ - Positive Patients with EC § [Day 1] [Day 14 or 21] 20 20 14 20 20 14 50 100 150 50 100 150 4.1±1.4 8.0±2.4 11.6±3.1 5.1±1.0 10.1±2.6 16.4±6.5 36±9 108±31 151±45 54±13 115±25 167±40 14.9±4.3 13.8±3.0 14.1±2.6 15.6±2.8 16.9±4.4 15.2±2.2 0.321 ±0.098 0.327 ±0.093 0.340 ±0.092 0.300±0.063 0.301±0.086 0.297±0.081 HSCT ¶ Recipients [Day 7] 8 10 8 8 per kg 3 4 6 8 21.1±2.84 29.2±6.2 38.4±6.9 60.8±26.9 234±34 339±72 479±157 663±212 14.0±1.4 14.2±3.2 14.9±2.6 17.2±2.3 0.214±0.031 0.204±0.036 0.224±0.064 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) B ody weight group N D ose* m g/kg C m a x .ss † (m c g/mL) AUC .ss † (m c g·h /mL) t 1/2 ‡ ( h) CL ‡ (m L/ m i n/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.

Specific Populations Adult Patients with Renal Impairment Micafungin for injection does not require dose adjustment in patients with renal impairment. A single 1-hour infusion of 100 mg micafungin for injection was administered to 9 adult subjects with severe renal impairment (creatinine clearance less than 30 mL/min) and to 9 age-, gender-, and weight-matched subjects with normal renal function (creatinine clearance greater than 80 mL/min). The maximum concentration (C max ) and AUC were not significantly altered by severe renal impairment.

Since micafungin is highly protein bound, it is not dialyzable. Supplementary dosing should not be required following hemodialysis. Adult Patients with Hepatic Impairment A single 1-hour infusion of 100 mg micafungin for injection was administered to 8 adult subjects with moderate hepatic impairment (Child-Pugh score 7 to 9) and 8 age-, gender-, and weight-matched subjects with normal hepatic function.

The C max and AUC values of micafungin were lower by approximately 22% in subjects with moderate hepatic impairment compared to normal subjects. This difference in micafungin exposure does not require dose adjustment of micafungin for injection in patients with moderate hepatic impairment. A single 1-hour infusion of 100 mg micafun… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

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. T able 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) C aspofungin 70/50 mg/day* n (%) T reatment 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 C andidemia A bscess A cute Disseminated ‡ Endophthalmitis Chorioretinitis Skin Kidney Pancreas Peritoneum Lung/Skin Lung/Spleen Liver Intraabdominal abscess C hronic Disseminated P e ritonitis 116/163 (71.2) 4/5 (80) 6/13 (46.2) 1/3 0/3 1/1 2/2 1/1 1/1 0/1 0/1 0 0 103/161 (64) 5/9 (55.6) 5/9 (55.6) 1/1 0 0 1/1 0 0 0 0 0/2 3/5 0/1 4/6 (66.7) 0 2/5 (40) Success by Organism § C . albicans C. glabrata C. tropicalis C . parapsilosis C . krusei C . guilliermondii C . lusitaniae 57/81 (70.4) 16/23 (69.6) 17/27 (63) 21/28 (75) 5/8 (62.5) 1/2 2/3 (66.7) 45/73 (61.6) 19/31 (61.3) 22/29 (75.9) 22/39 (56.4) 2/3 (66.7) 0/1 2/2 R elapse through 6 Weeks ¶ Overall Culture-confirmed relapse Required systemic antifungal therapy Died during follow-up Not assessed 49/135 (36.3) 5 11 17 16 44/119 (37) 4 5 16 19 O verall study mortality Mortality during IV therapy 58/200 (29) 28/200 (14) 51/193 (26.4) 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 fluc… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence 25 words ▾

9 DRUG ABUSE AND DEPENDENCE There has been no evidence of either psychological or physical dependence or withdrawal or rebound effects with micafungin for injection.

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Hepatic carcinomas and adenomas were observed in a 6-month intravenous toxicology study with an 18-month recovery period of micafungin sodium in rats designed to assess the reversibility of hepatocellular lesions. Rats administered micafungin sodium for 3 months at 32 mg/kg/day (corresponding to 8 times the highest recommended human dose [150 mg/day], based on AUC comparisons), exhibited colored patches/zones, multinucleated hepatocytes and altered hepatocellular foci after 1 or 3-month recovery periods, and adenomas were observed after a 21-month recovery period.

Rats administered micafungin sodium at the same dose for 6 months exhibited adenomas after a 12-month recovery period; after an 18-month recovery period, an increased incidence of adenomas was observed, and additionally, carcinomas were detected. A lower dose of micafungin sodium (equivalent to 5 times the human AUC) in the 6-month rat study resulted in a lower incidence of adenomas and carcinomas following 18 months recovery. The duration of micafungin for injection dosing in these rat studies (3 or 6 months) exceeds the usual duration of micafungin dosing in patients, which is typically less than 1 month for treatment of esophageal candidiasis, but dosing may exceed 1 month for Candida prophylaxis.

Although the increase in carcinomas in the 6-month rat study did not reach statistical significance, the persistence of altered hepatocellular foci subsequent to micafungin for injection dosing, and the presence of adenomas and carcinomas in the recovery periods suggest a causal relationship between micafungin sodium, altered hepatocellular foci, and hepatic neoplasms. Whole-life carcinogenicity studies of micafungin for injection in animals have not been conducted, and it is not known whether the hepatic neoplasms observed in treated rats also occur in other species, or if there is a dose threshold for this effect.

Micafungin sodium was not mutagenic or clastogenic when evaluated in a standard battery of i n vitro and in vivo tests (i.e., bacterial reversion - S. typhimurium, E. coli ; chromosomal aberration; intravenous mouse micronucleus). Male rats treated intravenously with micafungin sodium for 9 weeks showed vacuolation of the epididymal ductal epithelial cells at or above 10 mg/kg (about 0.6 times the recommended clinical dose for esophageal candidiasis, based on body surface area comparisons). Higher doses (about twice the recommended clinical dose, based on body surface area comparisons) resulted in higher epididymis weights and reduced numbers of sperm cells.

In a 39-week intravenous study in dogs, seminiferous tubular atrophy and decreased sperm in the epididymis were observed at 10 and 32 mg/kg, doses equal to about 2 and 7 times the recommended clinical dose, based on body surface area comparisons. There was no impairment of fertility in animal studies with micafungin sodium.

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 )] .

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Hepatic carcinomas and adenomas were observed in a 6-month intravenous toxicology study with an 18-month recovery period of micafungin sodium in rats designed to assess the reversibility of hepatocellular lesions. Rats administered micafungin sodium for 3 months at 32 mg/kg/day (corresponding to 8 times the highest recommended human dose [150 mg/day], based on AUC comparisons), exhibited colored patches/zones, multinucleated hepatocytes and altered hepatocellular foci after 1 or 3-month recovery periods, and adenomas were observed after a 21-month recovery period.

Rats administered micafungin sodium at the same dose for 6 months exhibited adenomas after a 12-month recovery period; after an 18-month recovery period, an increased incidence of adenomas was observed, and additionally, carcinomas were detected. A lower dose of micafungin sodium (equivalent to 5 times the human AUC) in the 6-month rat study resulted in a lower incidence of adenomas and carcinomas following 18 months recovery. The duration of micafungin for injection dosing in these rat studies (3 or 6 months) exceeds the usual duration of micafungin dosing in patients, which is typically less than 1 month for treatment of esophageal candidiasis, but dosing may exceed 1 month for Candida prophylaxis.

Although the increase in carcinomas in the 6-month rat study did not reach statistical significance, the persistence of altered hepatocellular foci subsequent to micafungin for injection dosing, and the presence of adenomas and carcinomas in the recovery periods suggest a causal relationship between micafungin sodium, altered hepatocellular foci, and hepatic neoplasms. Whole-life carcinogenicity studies of micafungin for injection in animals have not been conducted, and it is not known whether the hepatic neoplasms observed in treated rats also occur in other species, or if there is a dose threshold for this effect.

Micafungin sodium was not mutagenic or clastogenic when evaluated in a standard battery of i n vitro and in vivo tests (i.e., bacterial reversion - S. typhimurium, E. coli ; chromosomal aberration; intravenous mouse micronucleus). Male rats treated intravenously with micafungin sodium for 9 weeks showed vacuolation of the epididymal ductal epithelial cells at or above 10 mg/kg (about 0.6 times the recommended clinical dose for esophageal candidiasis, based on body surface area comparisons). Higher doses (about twice the recommended clinical dose, based on body surface area comparisons) resulted in higher epididymis weights and reduced numbers of sperm cells.

In a 39-week intravenous study in dogs, seminiferous tubular atrophy and decreased sperm in the epididymis were observed at 10 and 32 mg/kg, doses equal to about 2 and 7 times the recommended clinical dose, based on body surface area comparisons. There was no impairment of fertility in animal studies with micafungin sodium.

📄 Package Label / Principal Display Panel 18 words ▾

PRINCIPAL DISPLAY PANEL - 50 mg 50 mg carton

PRINCIPAL DISPLAY PANEL - 100 mg 100 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.
📅 Q1 2025 – Q4 2025 · 4 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
13
Units reimbursed last 4 qtrs
92
Gross reimbursed last 4 qtrs
$8.3K
Avg / prescription
$642.02
Avg / unit
$90.7200
Latest quarter Q4 2025
0Rx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 13 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 92 units · 0.2 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.20.2
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 0.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
Par Health USA, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2247 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.
← 42023-0224-01 · Par 42023-0230-10 · Par →
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.