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Pentam 300 PENTAMIDINE ISETHIONATE 300 mg/3mL Injection, Powder, Lyophilized, For Solution — NDC 63323-113-10 (Billing 63323-0113-10)

by Fresenius Kabi USA, LLC · 10 VIAL in 1 TRAY / 3 mL in 1 VIAL

This is a package of Pentam 300 PENTAMIDINE ISETHIONATE 300 mg/3mL Injection, Powder, Lyophilized, For Solution from Fresenius Kabi USA, LLC, marketed since Jan 2001 and currently FDA-listed. It is this product's only package size.

NDC 63323-0113-10
🏷️ FDA NDC (as labeled) 63323-113-10 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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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 63323-113-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63323 labeler · 113 product · 10 package
Package marketed since
Jan 16, 2001
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0363323113018
Medicaid fills, this package
600 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63323-113-10
Product NDC 63323-113
11-digit billing NDC 63323011310
NCPDP billing unit EA — each (per item)
RxCUI 861601, 861604
UNII V2P3K60DA2
UPC 0363323113018
Application # NDA019264
SPL Set ID cc2b635e-4840-4dc3-a177-5484371680e8
Established class (EPC) Antiprotozoal
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2001-01-16
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance PENTAMIDINE ISETHIONATE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 16000045002130
GPI class Pentam
GCN Seq No 009599
GCN 42990
HICL code 004162
Ingredient (HICL) Pentamidine Isethionate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W4
Therapeutic class — intermediate (HIC2) Antiparasitics
HIC3 code W4K
Therapeutic class — specific (HIC3) Antiprotozoal Drugs,Miscellaneous
AHFS code 08:30.12.00
AHFS class Antiprotozoals, P Jirovecii Pneumonia
FDB label name PENTAM 300 MG VIAL
FDB brand name Pentam 300
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009599
  • GCN: 42990
  • GPI-14 (Medi-Span): 16000045002130
  • HICL (First Databank): 004162
  • AHFS class code: 08:30.12.00
  • RxCUI (RxNorm): 861601
Why two NDCs? The FDA registers this code as 63323-113-10 — 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 → 63323-0113-10. 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 Antiprotozoal class.

Pharmacologic class Antiprotozoal
Drug family (ATC) Other agents against leishmaniasis and trypanosomiasis
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 PENTAM 300 MG VIAL Ingredient Pentamidine Isethionate
📗 Our plain-language guide HelloPharmacist
  • It helps prevent Pneumocystis pneumonia, a serious lung infection, in people with HIV who are at high risk. That means a past episode of PJP or a low CD4+ count (200/mm³ or lower).
  • The inhaled form is breathed in as a mist through a nebulizer. In the studies, this was done every two or four weeks. Your prescriber will tell you your schedule, so follow it clos...
  • Cough, tiredness, decreased appetite, dizziness, fever, wheezing and shortness of breath were commonly reported. Some people notice a bad taste, nausea or diarrhea. Tell your care...
  • Get help for trouble breathing, swelling, fainting, a racing or irregular heartbeat, severe stomach pain, or signs of low blood sugar like shakiness or confusion. These can be seri...
📖 Read our full Pentamidine Oral Inhalation guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
8
Nutrient depletion considerations

Pentamidine may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Pentamidine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $113.98 $3,419.34 / 30 ml
Medicare drug plans payPart D · Q2 2026 $164.21 $4,926.32 / 30 ml
Medicare Part B allowsASP · J2516 $0.160 / J2516 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)63323-113-10
11-digit billing NDC63323-0113-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2516
DescriptorINJECTION, PENTAMIDINE ISETHIONATE, 1 MG
Billing units / pkg300 units
How the units are derivedThis package is 10 EA; the HCPCS unit is 1 MG, so one package = 300 billing units.
Medicare Part B spend (2026 (Q1))$5,358 · 73 claims · $73.39 per claim (all NDCs under J2516)
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
63323-0113-10 You're viewing this Main listing 10 VIAL in 1 TRAY / 3 mL in 1 VIAL 2001-01-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pentamidine Isethionate 300 mg/300mg 00121-1101-02 PAI 10 vials — AP FDA listed —
Pentamidine Isethionate 300 mg/300mg 13925-0515-10 Seton 10 vials — AP FDA listed —
pentamidine isethionate 300 mg/300mg 23155-0748-41 Heritage 10 vials — AP FDA listed —
Pentamidine Isethionate 300 mg/3mL 39822-3050-02 XGen 10 vials — — Discontinued —
Pentam 300 300 mg/3mLthis 63323-0113-10 Fresenius 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

🏛️
2001
On the market since
Jan 2001
📍
2026
Currently FDA-listed
25 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.

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

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationNDA019264 (NDA)
Labeler code63323
First marketedJan 2001
Product typeHuman Prescription Drug
Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 63323

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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

INDICATIONS AND USAGE Pentam 300 (pentamidine isethionate for injection) is indicated for the treatment of pneumonia due to Pneumocystis carinii .

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION CAUTION: DO NOT USE SODIUM CHLORIDE INJECTION, USP FOR INITIAL RECONSTITUTION BECAUSE PRECIPITATION WILL OCCUR. Pentamidine isethionate should be administered IM or IV only. The recommended regimen for adults and pediatric patients beyond 4 months of age is 4 mg/kg once a day for 14 to 21 days.

Therapy for longer than 21 days with pentamidine isethionate has also been used but may be associated with increased toxicity. Intramuscular Injection The contents of one vial (300 mg) should be dissolved in 3 mL of Sterile Water for Injection, USP at 22° - 30°C (72° - 86°F). The calculated daily dose should then be withdrawn and administered by deep IM injection.

Intravenous Injection The contents of one vial (300 mg) should first be dissolved in 3 to 5 mL of Sterile Water for Injection, USP, or 5% Dextrose Injection, USP at 22°- 30°C (72° - 86°F). The calculated dose of pentamidine isethionate should then be withdrawn and diluted further in 50 to 250 mL of 5% Dextrose Injection, USP. The diluted IV solutions containing pentamidine isethionate should be infused over a period of 60 to 120 minutes.

Aseptic technique should be employed in preparation of all solutions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Stability After reconstitution with sterile water, the Pentam solution is stable for 48 hours in the original vial at room temperature if protected from light.

To avoid crystallization,store at 22° - 30°C (72° - 86°F). Intravenous infusion solutions of pentamidine isethionate at 1 mg/mL and 2.5 mg/mL prepared in 5% Dextrose Injection, USP are stable at room temperature for up to 24 hours. Intravenous (IV) solutions of pentamidine isethionate have been shown to be incompatible with fluconazole and foscarnet sodium.

IV solutions of pentamidine isethionate have been shown to be compatible with IV solutions of zidovudine (AZT) and diltiazem hydrochloride.

Intramuscular Injection The contents of one vial (300 mg) should be dissolved in 3 mL of Sterile Water for Injection, USP at 22° - 30°C (72° - 86°F). The calculated daily dose should then be withdrawn and administered by deep IM injection.

Intravenous Injection The contents of one vial (300 mg) should first be dissolved in 3 to 5 mL of Sterile Water for Injection, USP, or 5% Dextrose Injection, USP at 22°- 30°C (72° - 86°F). The calculated dose of pentamidine isethionate should then be withdrawn and diluted further in 50 to 250 mL of 5% Dextrose Injection, USP. The diluted IV solutions containing pentamidine isethionate should be infused over a period of 60 to 120 minutes.

Aseptic technique should be employed in preparation of all solutions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Stability After reconstitution with sterile water, the Pentam solution is stable for 48 hours in the original vial at room temperature if protected from light. To avoid crystallization,store at 22° - 30°C (72° - 86°F). Intravenous infusion solutions of pentamidine isethionate at 1 mg/mL and 2.5 mg/mL prepared in 5% Dextrose Injection, USP are stable at room temperature for up to 24 hours.

Intravenous (IV) solutions of pentamidine isethionate have been shown to be incompatible with fluconazole and foscarnet sodium. IV solutions of pentamidine isethionate have been shown to be compatible with IV solutions of zidovudine (AZT) and diltiazem hydrochloride.

⛔ Contraindications 12 words ▾

CONTRAINDICATIONS Contraindicated in patients with a history of hypersensitivity to pentamidine isethionate.

⚠️ Warnings 193 words ▾

WARNINGS Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis and cardiac arrhythmias have been reported in patients treated with pentamidine isethionate, both by the IM and IV routes. Severe hypotension may result after a single IM or IV dose and is more likely with rapid IV administration (see PRECAUTIONS ). The administration of the drug should, therefore, be limited to the patients in whom Pneumocystis carinii has been demonstrated.

Patients should be closely monitored for the development of serious adverse reactions (see PRECAUTIONS and ADVERSE REACTIONS ). Extravasations have been reported which, in some instances, proceeded to ulceration, tissue necrosis and/or sloughing at the injection site. While not common, surgical debridement and skin grafting has been necessary in some of these cases; long-term sequelae have been reported.

Prevention is the most effective means of limiting the severity of extravasation. The intravenous needle or catheter must be properly positioned and closely observed throughout the period of pentamidine isethionate administration. If extravasation occurs, the injection should be discontinued immediately and restarted in another vein.

Because there are no known local treatment measures which have proven to be useful, management of the extravasation should be symptomatic.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. CAUTION : Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis and cardiac arrhythmias have been reported in patients treated with pentamidine isethionate, both by the IM and IV routes. Nephrotoxic events (increased creatinine, impaired renal function, azotemia, and renal failure) are common with the parenteral administration of pentamidine isethionate.

The administration of the drug should, therefore, be limited to the patients in whom Pneumocystis carinii has been demonstrated. The most frequently reported spontaneous adverse events (1 to 30%) reported in clinical trials, regardless of their relation to pentamidine isethionate therapy were as follows (n=424): Cardiovascular: Hypotension 5.0% Gastrointestinal: Anorexia/Nausea 5.9% Hematologic: Anemia Leukopenia Thrombocytopenia 1.2% 10.4% 2.6% Hepatic: Elevated liver function tests 8.7% Metabolic: Hypoglycemia 5.9% Neurologic: Confusion/hallucinations 1.7% Skin: Sterile abscess and/or necrosis, pain, or induration at the site of IM injection Rash 11.1% 3.3% Special Senses: Bad taste 1.7% Urogenital: Azotemia Elevated serum creatinine Elevated blood urea nitrogen Impaired renal function 8.5% 23.6% 6.6% 28.8% Adverse events with a frequency of less than 1% incidence were as follows (No causal relationship to treatment has been established for these adverse events): Body as a whole: Allergic reaction (i.e. urticaria, itching, rash), anaphylaxis, arthralgia, chills, extrapulmonary pneumocystosis, headache, night sweats, and Stevens-Johnson syndrome.

Cardiovascular: Abnormal ST segment of electrocardiogram, cardiac arrhythmias, cerebrovascular accident, hypertension, palpitations, phlebitis, syncope, tachycardia, vasodilatation, vasculitis and ventricular tachycardia. Gastrointestinal: Abdominal pain, diarrhea, dry mouth, dyspepsia, hematochezia, hypersalivation, melena, pancreatitis, splenomegaly, and vomiting. Hematological: Defibrination, eosinophilia, neutropenia, pancytopenia, and prolonged clotting time.

Hepatic: Hepatic dysfunction, hepatitis and hepatomegaly Metabolic: Hyperglycemia, hyperkalemia, hypocalcemia, and hypomagnesemia. Neurological: Anxiety, confusion, depression, dizziness, drowsiness, emotional lability, hypesthesia, insomnia, memory loss, neuropathy, nervousness, neuralgia, paranoia, paresthesia, peripheral neuropathy, seizure, tremors, unsteady gait, and vertigo. Respiratory system: Asthma, bronchitis, bronchospasm, chest congestion, chest tightness, coryza, cyanosis, eosinophilic or interstitial pneumonitis, gagging, hemoptysis, hyperventilation, laryngitis, laryngospasm, non-specific lung disorder, nasal congestion, pleuritis, pneumothorax, rales, rhinitis, shortness of breath, and tachypnea.

Skin: Desquamation, dry and breaking hair, dry skin, erythema, dermatitis, pruritus, rash, and urticaria. Special senses: Blepharitis, blurred vision, conjunctivitis, contact lens discomfort, eye pain or discomfort, loss of hearing, loss of taste, and loss of smell. Urogenital: Flank pain, hematuria, incontinence, nephritis, renal dysfunction and renal failure.

From post-marketing clinical experience with pentamidine isethionate, the following adverse events have been reported: cough, diabetes mellitus/ketoacidosis, dyspnea, infiltration (extravasation–see WARNINGS ), and torsades de pointes.

🆘 Overdosage 74 words ▾

OVERDOSAGE A 17 month old infant inadvertently received 1600 mg of intravenous pentamidine isethionate which was followed by renal and hepatic function impairment, hypotension and cardiopulmonary arrest. Treatment included cardiopulmonary resuscitation, epinephrine, atropine and intubation. In addition, a four hour course of charcoal hemoperfusion was accompanied by reduction of pentamidine serum concentration and stabilization of the patient’s condition.

The patient recovered from these adverse events, but later died due to an unknown cause. 1

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Pentamidine isethionate, an aromatic diamidine, is known to have activity against Pneumocystis carinii . The mode of action of pentamidine is not fully understood. In vitro studies indicate that the drug interferes with protozoal nuclear metabolism by inhibition of DNA, RNA, phospholipid and protein synthesis.

Pharmacokinetics Pharmacokinetic parameters following the administration of 4 mg/kg pentamidine isethionate as a single two-hour intravenous infusion or after a single intramuscular injection to 12 patients with AIDS are presented in the following table: Mean ± SD Cmax ng/mL Clearance L/h Half-life hours Vdss L Concentration ng/mL 8 hour 24 hour 2 hour I.V. infusion 4 mg/kg (N=6) 612 ± 371 248 ± 91 6.4 ± 1.3 821 ± 535 19.3 ± 16.9 2.9 ±

1.4I.M. 4 mg/kg (N=6) 209 ± 48 305 ± 81 9.4 ± 2.0 2724 ± 1066 22.9 ± 8.0 6.6 ±

3.5In seven patients treated with daily IM doses of pentamidine at 4 mg/kg for 10 to 12 days, plasma concentrations were between 300 to 500 ng/mL. The concentrations did not appreciably change with time after injection or from day to day. Higher plasma concentrations were encountered in patients with an elevated blood urea nitrogen.

The patients continued to excrete decreasing amounts of pentamidine in urine up to 6 to 8 weeks after cessation of the treatment. Following multiple intravenous administration of pentamidine isethionate (3.7 to 4 mg/kg/day infused over 4 hours) to 6 patients with AIDS being treated for PCP, the pharmacokinetic parameters obtained on Days 1,4 and 7 are summarized in the following table: Mean ± SD Cmax* ng/mL Cmin* ng/mL Clearance mL/min Renal Clearance mL/min/1.73 m 2 Creatinine Clearance mL/min/1.73 m 2 Day 1 175.3 ± 54 --- 5737 ± 1878 269 ± 149 97 ± 12 Day 4 210.9 ± 80 17.6 ± 9.5 3350 ± 1944 214 ± 145 93 ± 17 Day 7 256.7 ± 89 40.8 ± 16.1 1989 ± 566 134 ± 60 69 ± 17 *derived from Lidman Compared to the mean AUC on Day 1, AUC on Day 4 and Day 7 were about 2 and 3 fold higher, respectively, suggesting that steady state was not achieved by Day 7 of dosing.

In other published reports of pharmacokinetics of pentamidine following daily intravenous doses of 2 to 4 mg/kg/day, clearance ranged from 30 to 40 mL/min/kg and Vdss ranged from 200 to 400 L/kg. Reported values for terminal half-lives of 2.8 to 12 days is suggestive of a deep peripheral compartment. In the urine, up to 12% of the administered dose has been recovered during a dosing interval as unchanged pentamidine.

Tissue distribution was studied in mice given a single intraperitoneal injection of pentamidine at 10 mg/kg. The concentration was highest in the kidneys followed by the liver. In mice, pentamidine was excreted unchanged, primarily via the kidneys with some elimination in the feces.

The ratio of amounts excreted in the urine and feces (4:1) was constant over the period of study. Tissue distribution has also been studied in normal and in renally impaired dogs (N = 3 each) given 13 mg/kg of pentamidine IV, in 2 doses separated by five weeks. The concentration of pentamidine was highest in the liver followed by kidneys and lungs.

Pentamidine was concentrated in these organs approximately 70 to 1000 times that of the peak serum concentration. Similar findings were reported in normal and in renally impaired dogs (N = 2 each) given 97.5 mg/kg of pentamidine IV, in 15 daily doses. After repeated doses, the organs showed a further 3 to 7 fold accumulation while serum concentrations remained unchanged.

Pharmacokinetics Pharmacokinetic parameters following the administration of 4 mg/kg pentamidine isethionate as a single two-hour intravenous infusion or after a single intramuscular injection to 12 patients with AIDS are presented in the following table: Mean ± SD Cmax ng/mL Clearance L/h Half-life hours Vdss L Concentration ng/mL 8 hour 24 hour 2 hour I.V. infusion 4 mg/kg (N=6) 612 ± 371 248 ± 91 6.4 ± 1.3 821 ± 535 19.3 ± 16.9 2.9 ±

1.4I.M. 4 mg/kg (N=6) 209 ± 48 305 ± 81 9.4 ± 2.0 2724 ± 1066 22.9 ± 8.0… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 55 words ▾

HOW SUPPLIED PENTAM ® 300 (pentamidine isethionate for injection) Product Code Unit of Sale Strength Each 11310 NDC 63323-113-10 Unit of 10 300 mg NDC 63323-113-01 Lyophilized Product in Single Dose Vial Store dry product at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Preservative Free. Discard unused portion.

📋 Description 89 words ▾

DESCRIPTION Pentam 300 (pentamidine isethionate for injection), an anti-protozoal agent, is a sterile, nonpyrogenic, lyophilized product. After reconstitution, it should be administered by intramuscular (IM) or intravenous (IV) routes (see DOSAGE AND ADMINISTRATION ). Pentamidine isethionate is a white crystalline powder soluble in water and glycerin, slightly soluble in alcohol and insoluble in ether, acetone, and chloroform.

It is chemically designated as 4,4-[1,5-pentanediylbis(oxy)]bis-benzenecarboximidamid with the following structural formula: Each vial contains: Pentamidine isethionate . . . . . . . . . . . . . 300 mg pentam-structure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Pentamidine isethionate should be used with caution in patients with hypertension, hypotension, ventricular tachycardia, hypoglycemia, hyperglycemia, hypocalcemia, pancreatitis, leukopenia, thrombocytopenia, anemia, hepatic or renal dysfunction and Stevens-Johnson syndrome. Patients may develop sudden, severe hypotension after a single dose of pentamidine isethionate, whether given IV or IM. Therefore, patients receiving the drug should be lying down and the blood pressure should be monitored closely during administration of the drug and several times thereafter until the blood pressure is stable.

Equipment for emergency resuscitation should be readily available. If pentamidine isethionate is administered IV, it should be infused over a period of 60 to 120 minutes. Pentamidine isethionate-induced hypoglycemia has been associated with pancreatic islet cell necrosis and inappropriately high plasma insulin concentrations.

Hyperglycemia and diabetes mellitus, with or without preceding hypoglycemia, have also occurred, sometimes several months after therapy with pentamidine isethionate. Therefore, blood glucose levels should be monitored daily during therapy with pentamidine isethionate, and several times thereafter. Renal and Hepatic Impairment The efficacy or safety of alternative Pentam 300 dosing protocols have not been established for patients with impaired renal or hepatic function.

Laboratory Tests The following tests should be carried out before, during and after therapy: a) Daily blood urea nitrogen and serum creatinine determinations. b) Daily blood glucose determinations. c) Complete blood count and platelet count. d) Liver function test, including serum bilirubin, alkaline phosphatase, AST (SGOT), and ALT (SGPT). e) Serum calcium determinations. f) Electrocardiograms. Drug Interactions No drug interaction studies with Pentam 300 have been conducted. Because the nephrotoxic effects may be additive, the concomitant or sequential use of pentamidine isethionate and other nephrotoxic drugs such as aminoglycosides, amphotericin B, cisplatin, foscarnet, or vancomycin should be closely monitored and avoided, if possible.

Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted to evaluate the potential of pentamidine isethionate as a carcinogen, mutagen, or cause of impaired fertility. Pregnancy-Pregnancy Category C Animal reproduction studies have not been conducted with pentamidine isethionate. It is also not known whether pentamidine isethionate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Pentamidine isethionate should not be given to a pregnant woman unless the potential benefits are judged to outweigh the unknown risks. Nursing Mothers It is not known whether pentamidine isethionate is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from pentamidine isethionate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Because many drugs are excreted in human milk, pentamidine isethionate should not be given to a nursing mother unless the potential benefits are judged to outweigh the unknown risks. Pediatric Use Intravenous and intramuscular pentamidine has been described as an effective treatment for Pneumocystis carinii pneumonia (PCP) in immunocompromised pediatric patients beyond 4 months of age. The efficacy and safety profiles in these pediatric patients were similar to those observed in adult patients (See DOSAGE AND ADMINISTRATION and OVERDOSAGE ) .

General Pentamidine isethionate should be used with caution in patients with hypertension, hypotension, ventricular tachycardia, hypoglycemia, hyperglycemia, hypocalcemia, pancreatitis, leukopenia, thrombocytopenia, anemia, hepatic or renal dysfunction and Stevens-Johnson syndrome. Patients may develop sudden, severe hypotension after… [Excerpted — this section continues on DailyMed.]

📚 References 27 words ▾

REFERENCE Watts RG; Conte JE, Jr.; Zurlinden E; Waldo FB: Effect of charcoal hemoperfusion on clearance of pentamidine isethionate after accidental overdose. J Toxicol Clin Toxicol 1997;35:89-92.

📄 Package Label / Principal Display Panel 100 words ▾

PACKAGE LABEL - PRINCIPAL DISPLAY – Pentam ® 300 mg Single Dose Vial Label NDC 63323-113-01 11310 PENTAM ® 300 (pentamidine isethionate for injection) 300 mg Lyophilized For IM or IV Use Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Pentam® 300 mg Single Dose Vial Label

PACKAGE LABEL - PRINCIPAL DISPLAY – Pentam ® 300 mg Single Dose Tray Label NDC 63323-113-10 11310 PENTAM ® 300 (pentamidine isethionate for injection) 300 mg Lyophilized For Intramuscular or Intravenous Use Rx only 10 Single Dose Vials PACKAGE LABEL - PRINCIPAL DISPLAY – Pentam®300 mg Single Dose Tray Label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
600
Units reimbursed last 4 qtrs
548
Gross reimbursed last 4 qtrs
$62.5K
Avg / prescription
$104.10
Avg / unit
$113.98
Latest quarter Q1 2026
59Rx
Fee-for-service vs managed care ⓘ
40% FFS 60% MCO
Fee-for-service · 240 Rx Managed care · 360 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: 93 units · 0.9 per 100k residents MI New York: 27 units · 0.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 9 units · 0.2 per 100k residents OR Nevada: 210 units · 6.6 per 100k residents 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: 104 units · 0.3 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: 66 units · 1.5 per 100k residents 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: 6 units · 0.0 per 100k residents FL
Units reimbursed · per 100k residents
0.06.6
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 Nevada 6.6 /100k
2 Kentucky 1.5 /100k
3 Michigan 0.9 /100k
4 California 0.3 /100k
5 Oregon 0.2 /100k
6 New York 0.1 /100k
7 Florida 0.0 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Pentamidine Isethionate (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Pentamidine Isethionate. 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
$2.1K
Claims incl. refills
19
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$108.06
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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Pentam 300 (this brand).

Top reported reactions

Febrile Neutropenia132
Pyrexia126
Aplastic Anaemia77
Diarrhoea73
Neutropenia73
Mucosal Inflammation57
Pneumonia55

Reporter sex

1,089 reports

Serious outcomes

Death201
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 88 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — 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 ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fresenius Kabi 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 J2516 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.
← 63323-0108-26 · Fresenius 63323-0117-59 · Fresenius →
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.