Home › NDC Lookup › Ingredients › Foscarnet Sodium › 65145-0191-10
💉image loading
(from DailyMed)

Foscarnet Sodium 24 mg/mL Injection, Solution — NDC 65145-191-10 (Billing 65145-0191-10)

by Caplin Steriles Limited · 10 POUCH in 1 CASE / 1 BAG in 1 POUCH / 250 mL in 1 BAG

This is a package of Foscarnet Sodium 24 mg/mL Injection, Solution from Caplin Steriles Limited, marketed since May 2026 and currently FDA-listed. It is this product's only package size.

NDC 65145-0191-10
🏷️ FDA NDC (as labeled) 65145-191-10 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65145-191-10
Product NDC 65145-191
11-digit billing NDC 65145019110
RxCUI 1734377
UNII 964YS0OOG1
UPC 0365145191014
Application # ANDA220068
SPL Set ID 6ec3bb2a-fb40-4d4a-bc1b-feea80cc1a95
Established class (EPC) Pyrophosphate Analog DNA Polymerase Inhibitor
Mechanism of action Chelating Activity; DNA Polymerase Inhibitors
Chemical class Pyrophosphate Analog
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-20
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance FOSCARNET SODIUM
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1734377
Why two NDCs? The FDA registers this code as 65145-191-10 — 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 → 65145-0191-10. 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 Pyrophosphate Analog DNA Polymerase Inhibitor class.

Pharmacologic class Pyrophosphate Analog DNA Polymerase Inhibitor
Drug family (ATC) Phosphonic acid derivatives
How it works Chelating Activity, DNA Polymerase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It treats CMV retinitis, an eye infection, in people with AIDS. It also treats herpes simplex infections of the skin and mucous membranes that no longer respond to acyclovir, in pe...
  • It is given as a slow IV infusion with a pump, along with fluids to protect your kidneys. It should never be pushed in quickly. Your team sets the schedule based on your weight and...
  • Foscarnet can harm the kidneys and change levels of calcium, magnesium, potassium and phosphate. Regular tests let your team adjust the dose and treat problems early.
  • Tell your nurse about tingling around the mouth, numbness in your hands or feet, muscle spasms or a seizure. Also report hives, swelling, trouble breathing, a racing or irregular h...
📖 Read our full Foscarnet Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Foscarnet may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Foscarnet 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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65145-0191-10 You're viewing this Main listing 10 POUCH in 1 CASE / 1 BAG in 1 POUCH / 250 mL in 1 BAG 2026-05-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Foscarnet Sodium 24 mg/mL 00143-9192-01 Hikma 1 bottle — AP FDA listed —
foscarnet sodium 24 mg/mL 23155-0771-41 Heritage 1 bottle — AP Discontinued —
Foscarnet Sodium 24 mg/mL 25021-0189-84 Sagent 250 ml — AP FDA listed —
Foscarnet Sodium 6000 mg/250mL 43066-0089-10 Baxter 250 ml — AP FDA listed —
Foscarnet 24 mg/mL 63323-0875-50 Fresenius 1 bottle — AP FDA listed —
Foscarnet Sodium 24 mg/mLthis 65145-0191-10 Caplin 10 pouches — AP FDA listed —
Foscarnet Sodium 24 mg/mL 68083-0389-01 Gland 250 ml — AP FDA listed —
Foscarnet Sodium 24 mg/mL 70121-1744-02 Amneal 12 pouches — AP FDA listed —
Foscavir 24 mg/mL 76310-0024-45 Clinigen 10 pouches — AP Discontinued —
Foscarnet Sodium 24 mg/mL 70069-0864-10 Somerset 10 pouches — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

Inactive Ingredients / Excipients

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

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

LabelerCaplin Steriles Limited
Application holderCAPLIN STERILES LTD
FDA applicationANDA220068 (ANDA)
Labeler code65145
First marketedMay 2026
Product typeHuman Prescription Drug
Portfolio88 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 96 words ▾

WARNING RENAL IMPAIRMENT IS THE MAJOR TOXICITY OF FOSCARNET SODIUM INJECTION. FREQUENT MONITORING OF SERUM CREATININE, WITH DOSE ADJUSTMENT FOR CHANGES IN RENAL FUNCTION, AND ADEQUATE HYDRATION WITH ADMINISTRATION OF FOSCARNET SODIUM INJECTION IS IMPERATIVE.(See ADMINISTRATION section; Hydration.) SEIZURES, RELATED TO ALTERATIONS IN PLASMA MINERALS AND ELECTROLYTES, HAVE BEEN ASSOCIATED WITH FOSCARNET SODIUM INJECTION TREATMENT. THEREFORE, PATIENTS MUST BE CAREFULLY MONITORED FOR SUCH CHANGES AND THEIR POTENTIAL SEQUELAE.MINERAL AND ELECTROLYTE SUPPLEMENTATION MAY BE REQUIRED.

FOSCARNET SODIUM INJECTION IS INDICATED FOR USE ONLY IN IMMUNOCOMPROMISED PATIENTS WITH CMV RETINITIS AND MUCOCUTANEOUS ACYCLOVIR-RESISTANT HSV INFECTIONS. (See INDICATIONS section).

🎯 Indications and Usage 120 words ▾

INDICATIONS CMV Retinitis Foscarnet sodium injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Combination therapy with foscarnet sodium injection and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. SAFETY AND EFFICACY OF FOSCARNET SODIUM INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (e.g., PNEUMONITIS, GASTROENTERITIS); CONGENITAL OR NEONATAL CMV DISEASE; OR NONIMMUNOCOMPROMISED INDIVIDUALS.

Mucocutaneous Acyclovir Resistant HSV Infections Foscarnet sodium injection is indicated for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients. SAFETY AND EFFICACY OF FOSCARNET SODIUM INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER HSV INFECTIONS (e.g., RETINITIS, ENCEPHALITIS); CONGENITAL OR NEONATAL HSV DISEASE; OR HSV IN NONIMMUNOCOMPROMISED INDIVIDUALS.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE & ADMINISTRATION CAUTION - DO NOT ADMINISTER FOSCARNET SODIUM INJECTION BY RAPID OR BOLUS INTRAVENOUS INJECTION. THE TOXICITY OF FOSCARNET SODIUM INJECTION MAY BE INCREASED AS A RESULT OF EXCESSIVE PLASMA LEVELS. CARE SHOULD BE TAKEN TO AVOID UNINTENTIONAL OVERDOSE BY CAREFULLY CONTROLLING THE RATE OF INFUSION.

THEREFORE, AN INFUSION PUMP MUST BE USED. IN SPITE OF THE USE OF AN INFUSION PUMP, OVERDOSES HAVE OCCURRED. ADMINISTRATION Instructions for Administration and Preparation Foscarnet sodium injection is administered by controlled intravenous infusion, either by using a central venous line or by using a peripheral vein.

The rate of infusion must be no more than 1 mg/kg/minute. An individualized dose of foscarnet sodium injection should be calculated on the basis of body weight (mg/kg), renal function, indication of use and dosing frequency (refer to DOSAGE subsection). To reduce the risk of nephrotoxicity, creatinine clearance (mL/min/kg) should be calculated even if serum creatinine is within the normal range, and doses should be adjusted accordingly.

An individualized dose at the required concentration (24 mg/mL or 12 mg/mL) for the route of administration (central line or peripheral line) needs to be aseptically prepared prior to dispensing. The standard 24 mg/mL solution may be used with or without dilution when using a central venous catheter for infusion. When a peripheral vein catheter is used, the 24 mg/mL injection must be diluted to a 12 mg/mL concentration with 5% dextrose in water or with a normal saline solution prior to administration to avoid local irritation of peripheral veins.

Dilutions and/or removals of excess quantities should be accomplished under aseptic conditions. Solutions thus prepared should be used within 24 hours of first entry into a infusion bag. Hydration Hydration may reduce the risk of nephrotoxicity.

Clinically dehydrated patients should have their condition corrected before initiating foscarnet sodium injection therapy. It is recommended that 750-1000 mL of normal saline or 5% dextrose solution should be given prior to the first infusion of foscarnet sodium injection to establish diuresis. With subsequent infusions, 750-1000 mL of hydration fluid should be given with 90-120 mg/kg of foscarnet sodium injection, and 500 mL with 40-60 mg/kg of foscarnet sodium injection.

Hydration fluid may need to be decreased if clinically warranted. Oral rehydration with similar regimens may be considered in certain patients. After the first dose, the hydration fluid should be administered concurrently with each infusion of foscarnet sodium injection.

Compatibility With Other Solutions/Drugs Other drugs and supplements can be administered to a patient receiving foscarnet sodium injection. However, care must be taken to ensure that foscarnet sodium injection is only administered with normal saline or 5% dextrose solution and that no other drug or supplement is administered concurrently via the same catheter. Foscarnet has been reported to be chemically incompatible with 30% dextrose, amphotericin B, and solutions containing calcium such as Ringer’s lactate and TPN.

Physical incompatibility with other IV drugs has also been reported including acyclovir sodium, ganciclovir, trimetrexate glucuronate, pentamidine isethionate, vancomycin, trimethoprim/sulfamethoxazole, diazepam, midazolam, digoxin, phenytoin, leucovorin, and proclorperazine. Because of foscarnet’s chelating properties, a precipitate can potentially occur when divalent cations are administered concurrently in the same catheter. Parenteral drug products must be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.

Solutions that are discolored or contain particulate matter should not be used. Accidental Exposure Accidental skin and eye contact with foscarnet sodium solution may cause local irritation and burning sensation. If accidental contact occurs, the exposed… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 15 words ▾

CONTRAINDICATIONS Foscarnet sodium injection is contraindicated in patients with clinically significant hypersensitivity to foscarnet sodium.

⚠️ Warnings ~3 min read ▾

WARNINGS Renal Impairment THE MAJOR TOXICITY OF FOSCARNET SODIUM INJECTION IS RENAL IMPAIRMENT (see ADVERSE REACTIONS section). Renal impairment is most likely to become clinically evident during the second week of induction therapy, but may occur at any time during foscarnet sodium injection treatment. Renal function should be monitored carefully during both induction and maintenance therapy (see PATIENT MONITORING section).

Elevations in serum creatinine are usually, but not always, reversible following discontinuation or dose adjustment of foscarnet sodium injection. Safety and efficacy data for patients with baseline serum creatinine levels greater than 2.8 mg/dL or measured 24-hour creatinine clearances <50 mL/min are limited. SINCE FOSCARNET SODIUM INJECTION HAS THE POTENTIAL TO CAUSE RENAL IMPAIRMENT, DOSE ADJUSTMENT BASED ON SERUM CREATININE IS NECESSARY.

Hydration may reduce the risk of nephrotoxicity. It is recommended that 750–1000 mL of normal saline or 5% dextrose solution should be given prior to the first infusion of foscarnet sodium injection to establish diuresis. With subsequent infusions, 750–1000 mL of hydration fluid should be given with 90–120 mg/kg of foscarnet sodium injection, and 500 mL with 40–60 mg/kg of foscarnet sodium injection.

Hydration fluid may need to be decreased if clinically warranted. After the first dose, the hydration fluid should be administered concurrently with each infusion of foscarnet sodium injection. Mineral and Electrolyte Abnormalities Foscarnet sodium injection has been associated with changes in serum electrolytes including hypocalcemia, hypophosphatemia, hyperphosphatemia, hypomagnesemia, and hypokalemia (see ADVERSE REACTIONS section).

Foscarnet sodium injection may also be associated with a dose-related decrease in ionized serum calcium which may not be reflected in total serum calcium. This effect is likely to be related to chelation of divalent metal ions such as calcium by foscarnet. Patients should be advised to report symptoms of low ionized calcium such as perioral tingling, numbness in the extremities and paresthesias.

Particular caution and careful management of serum electrolytes is advised in patients with altered calcium or other electrolyte levels before treatment and especially in those with neurologic or cardiac abnormalities and those receiving other drugs known to influence minerals and electrolytes (see PATIENT MONITORING and Drug Interactions sections). Physicians should be prepared to treat these abnormalities and their sequelae such as tetany, seizures or cardiac disturbances. The rate of foscarnet sodium injection infusion may also affect the decrease in ionized calcium.

Therefore, an infusion pump must be used for administration to prevent rapid intravenous infusion (see DOSAGE AND ADMINISTRATION section). Slowing the infusion rate may decrease or prevent symptoms. Seizures Seizures related to mineral and electrolyte abnormalities have been associated with foscarnet sodium injection treatment (see WARNING section; Mineral and Electrolyte Abnormalities).

Several cases of seizures were associated with death. Cases of status epilepticus have been reported. Risk factors associated with seizures included impaired baseline renal function, low total serum calcium, and underlying CNS conditions.

Hypersensitivity Serious acute hypersensitivity reactions (e.g., anaphylactic shock, urticaria, angioedema) have been reported postmarketing in patients receiving foscarnet sodium injection (see ADVERSE REACTIONS section). If such an acute reaction occurs, therapy should be discontinued and appropriate medical therapy immediately instituted. QT prolongation and torsade de pointes Foscarnet sodium injection has been associated with prolongation of the QT interval, an ECG abnormality that has been associated with torsades de pointes, which has been reported during postmarketing surveillance for foscarnet sodium injection (see ADVERSE REACTIONS section).

Some of these… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS THE MAJOR TOXICITY OF FOSCARNET SODIUM INJECTION IS RENAL IMPAIRMENT (see WARNINGS section). Approximately 33% of 189 patients with AIDS and CMV retinitis who received foscarnet sodium injection (60 mg/kg TID), without adequate hydration, developed significant impairment of renal function (serum creatinine ≥ 2.0 mg/dL). The incidence of renal impairment in subsequent clinical trials in which 1000 mL of normal saline or 5% dextrose solution was given with each infusion of foscarnet sodium injection was 12% (34/280).

Foscarnet sodium injection has been associated with changes in serum electrolytes including hypocalcemia (15–30%), hypophosphatemia (8–26%) and hyperphosphatemia (6%), hypomagnesemia (15– 30%), and hypokalemia (16–48%) (see WARNINGS section). The higher percentages were derived from those patients receiving hydration. Foscarnet sodium injection treatment was associated with seizures in 18/189 (10%) AIDS patients in the initial five controlled studies (see WARNINGS section).

Risk factors associated with seizures included impaired baseline renal function, low total serum calcium, and underlying CNS conditions predisposing the patient to seizures. The rate of seizures did not increase with duration of treatment. Three cases were associated with overdoses of foscarnet sodium injection (see OVERDOSAGE section).

In five controlled U.S. clinical trials the most frequently reported adverse events in patients with AIDS and CMV retinitis are shown in Table 9. These figures were calculated without reference to drug relationship or severity. TABLE 9 Adverse Events Reported in Five Controlled US Clinical Trials n = 189 n = 189 Fever 65% Abnormal Renal Function 27% Nausea 47% Vomiting 26% Anemia 33% Headache 26% Diarrhea 30% Seizures 10% From the same controlled studies, adverse events categorized by investigator as “severe” are shown in Table 10.

Although death was specifically attributed to foscarnet sodium injection in only one case, other complications of foscarnet sodium injection (i.e., renal impairment, electrolyte abnormalities, and seizures) may have contributed to patient deaths (see WARNINGS section). TABLE 10 Severe Adverse Events n = 189 Death 14% Abnormal Renal Function 14% Marrow Suppression 10% Anemia 9% Seizures 7% From the five initial U.S. controlled trials of foscarnet sodium injection, the following list of adverse events has been compiled regardless of causal relationship to foscarnet sodium injection.

Evaluation of these reports was difficult because of the diverse manifestations of the underlying disease and because most patients received numerous concomitant medications. Incidence of 5% or Greater Body as a Whole: fever, fatigue, rigors, asthenia, malaise, pain, infection, sepsis, death Central and Peripheral Nervous System: headache, paresthesia, dizziness, involuntary muscle contractions, hypoesthesia, neuropathy, seizures including grand mal seizures (see WARNINGS) Gastrointestinal System: anorexia, nausea, diarrhea, vomiting, abdominal pain Hematologic: anemia, granulocytopenia, leukopenia, neutropenia (see PRECAUTIONS) Metabolic and Nutritional: mineral and electrolyte imbalances (see WARNINGS) including hypokalemia, hypocalcemia, hypomagnesemia, hypophosphatemia, hyperphosphatemia Psychiatric: depression, confusion, anxiety Respiratory System: coughing, dyspnea Skin and Appendages: rash, increased sweating Urinary System: alterations in renal function including increased serum creatinine, decreased creatinine clearance, and abnormal renal function (see WARNINGS) Special Senses: vision abnormalities Incidence between 1% and 5% Application Site: injection site pain, injection site inflammation Body as a Whole: back pain, chest pain (including reports of transient chest pain as part of infusion reactions), edema, influenza-like symptoms, bacterial infections, moniliasis, fungal infections, abscess Cardiovascular: hypertension, palpitations, ECG abnormalities including sinus tachycardi… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

Drug Interactions A possible drug interaction of foscarnet sodium injection and intravenous pentamidine has been described. Concomitant treatment of four patients in the United Kingdom with foscarnet sodium injection and intravenous pentamidine may have caused hypocalcemia; one patient died with severe hypocalcemia. Toxicity associated with concomitant use of aerosolized pentamidine has not been reported.

Because foscarnet sodium injection can reduce serum levels of ionized calcium, extreme caution is advised when used concurrently with other drugs known to influence serum calcium levels (e.g., intravenous pentamidine). Renal impairment and symptomatic hypocalcemia have been observed during concurrent treatment with foscarnet sodium injection and intravenous pentamidine. Because of foscarnet’s tendency to cause renal impairment, the use of foscarnet sodium injection should be avoided in combination with potentially nephrotoxic drugs such as aminoglycosides, amphotericin B, cyclosporine, acyclovir, methotrexate, tacrolimus and intravenous pentamidine (see above) unless the potential benefits outweigh the risks to the patient.

When diuretics are indicated, thiazides are recommended over loop diuretics because the latter inhibit renal tubular secretion, and may impair elimination of foscarnet sodium injection, potentially leading to toxicity. Abnormal renal function has been observed in clinical practice during the use of foscarnet sodium injection and ritonavir, or foscarnet sodium injection, ritonavir, and saquinavir. (See DOSAGE and ADMINISTRATION.) Because of the risk of QT prolongation and the potential for torsades de pointes, the use of foscarnet sodium injection should be avoided in combination with agents known to prolong the QT interval including Class IA (e.g., quinidine or procainamide) or Class III (e.g., dofetilide, amiodarone, sotalol) antiarrhythmic agents, phenothiazines, tricyclic antidepressants, and certain macrolides and fluoroquinolones.

🤰 Pregnancy 205 words ▾

Preganacy There are no adequate and well-controlled studies of foscarnet sodium injection in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Animal Data: Foscarnet sodium injection did not adversely affect fertility and general reproductive performance in rats.

The results of peri- and post-natal studies in rats were also negative. However, these studies used exposures that are inadequate to define the potential for impairment of fertility at human drug exposure levels. Daily subcutaneous doses up to 75 mg/kg administered to female rats prior to and during mating, during gestation, and 21 days post-partum caused a slight increase (< 5%) in the number of skeletal anomalies compared with the control group.

Daily subcutaneous doses up to 75 mg/kg administered to rabbits and 150 mg/kg administered to rats during gestation caused an increase in the frequency of skeletal anomalies/variations. On the basis of estimated drug exposure (as measured by AUC), the 150 mg/kg dose in rats and 75 mg/kg dose in rabbits were approximately one-eighth (rat) and one-third (rabbit) the estimated maximal daily human exposure. These studies are inadequate to define the potential teratogenicity at levels to which women will be exposed.

🧒 Pediatric Use 114 words ▾

Pediatric Use The safety and effectiveness of foscarnet sodium injection in pediatric patients have not been established. Foscarnet sodium injection is deposited in teeth and bone and deposition is greater in young and growing animals. Foscarnet sodium injection has been demonstrated to adversely affect development of tooth enamel in mice and rats.

The effects of this deposition on skeletal development have not been studied. Since deposition in human bone has also been shown to occur, it is likely that it does so to a greater degree in developing bone in pediatric patients. Administration to pediatric patients should be undertaken only after careful evaluation and only if the potential benefits for treatment outweigh the risks.

🧓 Geriatric Use 112 words ▾

Geriatric Use No studies of the efficacy or safety of foscarnet sodium injection in persons 65 years of age or older have been conducted. However, foscarnet sodium injection has been used in patients age 65 years of age and older. The pattern of adverse events seen in these patients is consistent across all age groups.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored. (See DOSAGE AND ADMINISTRATION).

🆘 Overdosage ~1 min read ▾

OVERDOSAGE In controlled clinical trials performed in the United States, overdosage with foscarnet sodium injection was reported in 10 out of 189 patients. All 10 patients experienced adverse events and all except one made a complete recovery. One patient died after receiving a total daily dose of 12.5 g for three days instead of the intended 10.9 g.

The patient suffered a grand mal seizure and became comatose. Three days later the patient expired with the cause of death listed as respiratory/cardiac arrest. The other nine patients received doses ranging from 1.14 times to 8 times their recommended doses with an average of 4 times their recommended doses.

Overall, three patients had seizures, three patients had renal function impairment, four patients had paresthesias either in limbs or periorally, and five patients had documented electrolyte disturbances primarily involving calcium and phosphate. Overdose (up to 20 times the recommended dose) has been reported in post-marketing use of foscarnet sodium injection. Some of these post-marketing reports were relative overdoses in that the dose of foscarnet sodium injection had not been adjusted in patients with a reduced renal function.

The pattern of adverse events associated with a foscarnet sodium injection overdose is consistent with the known adverse event profile of the drug. There is no specific antidote for foscarnet sodium injection overdose. Hemodialysis and hydration may be of benefit in reducing drug plasma levels in patients who receive an overdosage of foscarnet sodium injection, but the effectiveness of these interventions has not been evaluated.

The patient should be observed for signs and symptoms of renal impairment and electrolyte imbalance. Medical treatment should be instituted if clinically warranted.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Pharmacokinetics The pharmacokinetics of foscarnet has been determined after administration as an intermittent intravenous infusion during induction therapy in AIDS patients with CMV retinitis. Observed plasma foscarnet concentrations in four studies (FOS-01, ACTG-015, FP48PK, FP49PK) are summarized in Table 7: TABLE 7 Foscarnet Pharmacokinetic Characteristics* Parameter 60 mg/kg Q8h 90 mg/kg Q12h C max at steady-state (μM) 589 ± 192 (24) 623 ± 132 (19) C trough at steady-state (μM) 114 ± 91 (24) 63 ± 57 (17) Volume of distribution (L/kg) 0.41 ± 0.13 (12) 0.52 ± 0.20 (18) Plasma half-life (hr) 4.0 ± 2.0 (24) 3.3 ± 1.4 (18) Systemic clearance (L/hr) 6.2 ± 2.1 (24) 7.1 ± 2.7 (18) Renal clearance (L/hr) 5.6 ± 1.9 (5) 6.4 ± 2.5 (13) CSF: plasma ratio 0.69 ± 0.19 (9) † 0.66 ± 0.11 (5) ‡ *Values expressed as mean S.D.

(number of subjects studied) for each parameter † 50 mg/kg Q8h for 28 days, samples taken 3 hrs after end of 1 hr infusion (Astra Report 815-04 AC025-1) ‡ 90 mg/kg Q12hr for 28 days, samples taken 1 hr after end of 2 hr infusion (Hengge et al., 1993) Distribution In vitro studies have shown that 14 – 17% of foscarnet is protein bound at plasma drug concentrations of 1 – 1000 μM. The foscarnet terminal half-life determined by urinary excretion was 87.5 ± 41.8 hours, possibly due to release of foscarnet from bone. Postmortem data on several patients in European clinical trials provide evidence that foscarnet does accumulate in bone in humans; however, the extent to which this occurs has not been determined.

Special Populations Adults with Impaired Renal Function: The pharmacokinetic properties of foscarnet have been determined in a small group of adult subjects with normal and impaired renal function, as summarized in Table 8: TABLE 8 Pharmacokinetic Parameters (mean ± S.D.) After a Single 60 mg/kg Dose of foscarnet sodium injection in 4 Groups* of Adults with Varying Degrees of Renal Function Parameter Group 1 (N=6) Group 2 (N=6) Group 3 (N=6) Group 4 (N=4) Creatinine clearance (mL/min) 108 ± 16 68 ± 8 34 ± 9 20 ± 4 Foscarnet CL (mL/min/kg) 2.13 ± 0.71 1.33 ± 0.43 0.46 ± 0.14 0.43 ±

0.26Foscarnet half-life (hr) 1.93 ± 0.12 3.35 ± 0.87 13.0 ± 4.05 25.3 ± 18.7 *Group 1 patients had normal renal function defined as a creatinine clearance (CrCl) of >80 mL/min, Group 2 CrCl was 50 – 80 mL/min, Group 3 CrCl was 25 – 49 mL/min and Group 4 CrCl was 10 – 24 mL/min. Total systemic clearance (CL) of foscarnet decreased and half-life increased with diminishing renal function (as expressed by creatinine clearance). Based on these observations, it is necessary to modify the dosage of foscarnet in patients with renal impairment (see DOSAGE AND ADMINISTRATION).

Drug Interaction The pharmacokinetics of foscarnet and ganciclovir were not altered in 13 patients receiving either concomitant therapy or daily alternating therapy for maintenance of CMV disease. There is no clinically significant interaction with zidovudine (AZT), or probenecid. CLINICAL TRIALS CMV Retinitis A prospective, randomized, controlled clinical trial (FOS-03) was conducted in 24 patients with AIDS and CMV retinitis comparing treatment with foscarnet sodium injection to no treatment.

Patients received induction treatment of foscarnet sodium injection , 60 mg/kg every 8 hours for 3 weeks, followed by maintenance treatment with 90 mg/kg/day until retinitis progression (appearance of a new lesion or advancement of the border of a posterior lesion greater than 750 microns in diameter). All diagnoses and determinations of retinitis progression were made from masked reading of retinal photographs. The 13 patients randomized to treatment with foscarnet sodium injection had a significant delay in progression of CMV retinitis compared to untreated controls.

Median times to retinitis progression from study entry were 93 days (range 21 – >364) and 22 days (range 7 – 42), respectively. In another prospective clinical trial of CMV retinitis in patients with… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 168 words ▾

HOW SUPPLIED Foscarnet sodium injection, 24 mg/mL for intravenous infusion, is supplied in 250 mL dual port infusion bag containing 6000 mg foscarnet sodium (24 mg/mL) as follows: Strength Each 6,000 mg/250 mL (24 mg/mL) NDC 65145-191-01 1 Single-dose Intravenous Bag in an Overwrap For single-dose only. Discard unused portion. Store between 20° and 25°C (68° and 77°F) [see USP Controlled Room Temperature].

Protect from excessive heat (above 40°C) and from freezing. If refrigerated or exposed to temperatures below the freezing point, precipitation may occur. By keeping the infusion bag at room temperature with repeated shaking, the precipitate can be brought into solution again.

Foscarnet sodium injection should be used only if the infusion bag and twist off port, injection port seals are intact, a vacuum is present, and the solution is clear and colorless. Do not remove the infusion bag from the overwrap until ready for use. Made in India Distributed by : Caplin Steriles USA Inc, Hamilton, NJ 08619.

Code: TN/Drugs/TN00006405 Revised: February 2026 22201310 caplin-logo

📋 Description ~3 min read ▾

DESCRIPTION The chemical name of foscarnet sodium is phosphonoformic acid, trisodium salt. Foscarnet sodium is a white, crystalline powder containing 6 equivalents of water of hydration with an empirical formula of Na 3 CO 5 P•6H 2 O and a molecular weight of 300.1. The structural formula: Foscarnet sodium injection has the potential to chelate divalent metal ions, such as calcium and magnesium, to form stable coordination compounds.

Foscarnet sodium injection is a sterile, isotonic aqueous solution for intravenous administration only. The solution is clear and colorless. Each milliliter of foscarnet sodium injection contains 24 mg of foscarnet sodium hexahydrate in Water for Injection, USP.

Hydrochloric acid may have been added to adjust the pH of the solution to 7.4. Foscarnet sodium injection contains no preservatives. VIROLOGY Mechanism of Action Foscarnet exerts its antiviral activity by a selective inhibition at the pyrophosphate binding site on virus-specific DNA polymerases at concentrations that do not affect cellular DNA polymerases.

Foscarnet does not require activation (phosphorylation) by thymidine kinase or other kinases. Antiviral Activity in Cell Culture The quantitative relationship between the cell culture susceptibility of human cytomegalovirus (CMV) or herpes simplex virus 1 and 2 (HSV-1 and HSV-2) to foscarnet and clinical response to therapy has not been established and virus sensitivity testing has not been standardized. Sensitivity test results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (EC 50 ), vary greatly depending on the assay method used, cell type employed and the laboratory performing the test.

A number of sensitive viruses and their EC 50 values are listed below (Table 1). The combination antiviral activity of foscarnet and ganciclovir or acyclovir are not antagonistic in cell culture. TABLE 1 Foscarnet Inhibition of Virus Replication in Cell Culture Virus EC 50 value (μM) CMV Ganciclovir resistant CMV HSV-1, HSV-2 HSV-TK negative mutant HSV-DNA polymerase mutants 50-800 * 190 10-130 67 5-443 *Mean = 269 μM Antiviral Activity in vivo Statistically significant decreases in positive CMV cultures from blood and urine have been demonstrated in two studies (FOS-03 and ACTG-015/915) of subjects treated with foscarnet sodium injection.

Although median time to progression of CMV retinitis was increased in subjects treated with foscarnet sodium injection, reductions in positive blood or urine cultures have not been shown to correlate with clinical efficacy in individual subjects (Table 2). TABLE 2 Blood and Urine Culture Results from CMV Retinitis Patients* Blood +CMV -CMV Baseline End of Induction † 27 1 34 60 Urine +CMV -CMV Baseline End of Induction † 52 21 6 37 *A total of 77 subjects were treated with foscarnet sodium injection in two clinical trials (FOS-03 and ACTG-015/915).

Not all subjects had blood or urine cultures done and some subjects had results from both cultures. † (60 mg/kg foscarnet sodium injection TID for 2–3 weeks). Resistance Cell culture: CMV and HSV isolates with reduced susceptibility to foscarnet have been selected in cell culture by passage of wild type virus in the presence of increasing concentrations of the drug. All foscarnet resistant isolates are known to be generated through amino acid substitutions in the viral DNA polymerase pUL54 (CMV) or pUL30 (HSV) (Table 3).

TABLE 3 Summary of Foscarnet Resistance-associated DNA Polymerase Amino Acid Substitutions in Cell Culture CMV pUL54 T419M, T552N, S585A, F595I, Q807A, M844T/V, V946L HSV-1 pUL30 Y577H, E597D, A605V, L702H, V714M, L774F, L788M, D780N, L782I, P797T, L802F, V813M, V817M, Y818C, T821M, R842S, S889A, F891C, V892M, D907V, A910V, SRA914-916LCV, V958L, R959H HSV-2 pUL30 - In vivo : Limited clinical data are available on the development of clinical resistance to foscarnet and many pathways to resistance likely exist. Substitutions documented in the literatur… [Excerpted — this section continues on DailyMed.]

💬 Information for Patients ~1 min read ▾

Information for Patients CMV Retinitis: Patients should be advised that foscarnet sodium injection is not a cure for CMV retinitis, and that they may continue to experience progression of retinitis during or following treatment. They should be advised to have regular ophthalmologic examinations. Mucocutaneous Acyclovir-Resistant HSV Infections: Patients should be advised that foscarnet sodium injection is not a cure for HSV infections.

While complete healing is possible, relapse occurs in most patients. Because relapse may be due to acyclovir-sensitive HSV, sensitivity testing of the viral isolate is advised. In addition, repeated treatment with foscarnet sodium injection has led to the development of resistance associated with poorer response.

In the case of poor therapeutic response, sensitivity testing of the viral isolate also is advised. Effects on Ability to Drive and Use Machines: Adverse effects such as dizziness and convulsions may occur during foscarnet sodium injection therapy. Patients who experience seizures, dizziness, somnolence or other adverse reactions that could result in impairment, should be advised to avoid driving or operating machinery.

General: Patients should be informed that the major toxicities of foscarnet are renal impairment, electrolyte disturbances, and seizures, and that dose modifications and possibly discontinuation may be required. The importance of close monitoring while on therapy must be emphasized. Patients should be advised of the importance of reporting to their physicians symptoms of perioral tingling, numbness in the extremities or paresthesias during or after infusion as possible symptoms of electrolyte abnormalities.

Patients should also be advised to promptly report any cardiac symptoms. Should such symptoms occur, the infusion of foscarnet sodium injection should be stopped, appropriate laboratory samples for assessment of electrolyte concentrations obtained, and a physician consulted before resuming treatment. The rate of infusion must be no more than 1 mg/kg/minute.

The potential for renal impairment may be minimized by accompanying foscarnet sodium injection administration with hydration adequate to establish and maintain a diuresis during dosing.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Care must be taken to infuse solutions containing foscarnet sodium injection only into veins with adequate blood flow to permit rapid dilution and distribution to avoid local irritation (see DOSAGE AND ADMINISTRATION). Local irritation and ulcerations of penile epithelium have been reported in male patients receiving foscarnet sodium injection, possibly related to the presence of drug in the urine. Cases of male and female genital irritation/ulceration have been reported in patients receiving foscarnet sodium injection.

Adequate hydration with close attention to personal hygiene may minimize the occurrence of such events. Due to the sodium content of foscarnet sodium injection (240 micromoles (5.5 mg) of sodium per mL), avoid foscarnet sodium injection use when intravenous infusion of a large amount of sodium or water may not be tolerated (e.g. in patients with cardiomyopathy). Foscarnet sodium injection should also be avoided in patients on a controlled sodium diet.

Hematopoietic System Anemia has been reported in 33% of patients receiving foscarnet sodium injection in controlled studies. Granulocytopenia has been reported in 17% of patients receiving foscarnet sodium injection in controlled studies; however, only 1% (2/189) were terminated from these studies because of neutropenia. Information for Patients CMV Retinitis: Patients should be advised that foscarnet sodium injection is not a cure for CMV retinitis, and that they may continue to experience progression of retinitis during or following treatment.

They should be advised to have regular ophthalmologic examinations. Mucocutaneous Acyclovir-Resistant HSV Infections: Patients should be advised that foscarnet sodium injection is not a cure for HSV infections. While complete healing is possible, relapse occurs in most patients.

Because relapse may be due to acyclovir-sensitive HSV, sensitivity testing of the viral isolate is advised. In addition, repeated treatment with foscarnet sodium injection has led to the development of resistance associated with poorer response. In the case of poor therapeutic response, sensitivity testing of the viral isolate also is advised.

Effects on Ability to Drive and Use Machines: Adverse effects such as dizziness and convulsions may occur during foscarnet sodium injection therapy. Patients who experience seizures, dizziness, somnolence or other adverse reactions that could result in impairment, should be advised to avoid driving or operating machinery. General: Patients should be informed that the major toxicities of foscarnet are renal impairment, electrolyte disturbances, and seizures, and that dose modifications and possibly discontinuation may be required.

The importance of close monitoring while on therapy must be emphasized. Patients should be advised of the importance of reporting to their physicians symptoms of perioral tingling, numbness in the extremities or paresthesias during or after infusion as possible symptoms of electrolyte abnormalities. Patients should also be advised to promptly report any cardiac symptoms.

Should such symptoms occur, the infusion of foscarnet sodium injection should be stopped, appropriate laboratory samples for assessment of electrolyte concentrations obtained, and a physician consulted before resuming treatment. The rate of infusion must be no more than 1 mg/kg/minute. The potential for renal impairment may be minimized by accompanying foscarnet sodium injection administration with hydration adequate to establish and maintain a diuresis during dosing.

Drug Interactions A possible drug interaction of foscarnet sodium injection and intravenous pentamidine has been described. Concomitant treatment of four patients in the United Kingdom with foscarnet sodium injection and intravenous pentamidine may have caused hypocalcemia; one patient died with severe hypocalcemia. Toxicity associated with concomitant use of aerosolized pentamidine has not been reported.

Because foscarnet sodium inj… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 96 words ▾

Nursing Mothers It is not known whether foscarnet sodium injection is excreted in human milk; however, in lactating rats administered 75 mg/kg, foscarnet sodium injection was excreted in maternal milk at concentrations three times higher than peak maternal blood concentrations. Because of the potential for serious adverse events in nursing infants, a decision should be made whether to discontinue nursing or discontinue drug, taking into consideration the importance of the drug to the mother. The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breast-feed their infants to avoid risking postnatal transmission of HIV.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 132 words ▾

Carcinogenesis &Mutagenesis & Impairment of Fertility Carcinogenicity studies were conducted in rats and mice at oral doses of 500 mg/kg/day and 250 mg/kg/day. Oral bioavailability in unfasted rodents is < 20%. No evidence of oncogenicity was reported at plasma drug levels equal to 1/3 and 1/5, respectively, of those in humans (at the maximum recommended human daily dose) as measured by the area-under-the- time/concentration curve (AUC).

Foscarnet sodium injection showed genotoxic effects in the BALB/3T3 in vitro transformation assay at concentrations greater than 0.5 mcg/mL and an increased frequency of chromosome aberrations in the sister chromatid exchange assay at 1000 mcg/mL. A high dose of foscarnet (350 mg/kg) caused an increase in micronucleated polychromatic erythrocytes in vivo in mice at doses that produced exposures (area under curve) comparable to that anticipated clinically.

📄 Package Label / Principal Display Panel 6 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL foscarnet-bag-label foscarnet-pouch-label

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

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Foscarnet Sodium — 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 Foscarnet Sodium. 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.
Total Part D spend
$29.6K
Claims incl. refills
18
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$1,642.96
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Caplin Steriles Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Caplin Steriles Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 65145-0184-01 · Caplin 65145-0192-25 · Caplin →
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.