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AmBisome amphotericin B 50 mg/12.5mL Injection, Powder, Lyophilized, For Solution, 12.5 mL — NDC 00469-3051-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

AmBisome amphotericin B 50 mg/12.5mL Injection, Powder, Lyophilized, For Solution, 12.5 mL — NDC 0469-3051-30 (Billing 00469-3051-30)

by Astellas Pharma US, Inc. · 12.5 mL in 1 VIAL, SINGLE-DOSE

This is a package of 12.5 mL of AmBisome amphotericin B 50 mg/12.5mL Injection, Powder, Lyophilized, For Solution from Astellas Pharma US, Inc., no longer marketed (first marketed Aug 1997), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 00469-3051-30
🏷️ FDA NDC (as labeled) 0469-3051-30 billing pads the labeler segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ 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

⚠️
Other active recalls for Amphotericin B (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 19, 2024 — Out of specification for assay (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0493-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0469-3051-30
Product NDC 0469-3051
11-digit billing NDC 00469305130
NCPDP billing unit EA — each (per item)
RxCUI 967385, 967388
UNII 7XU7A7DROE
Application # NDA050740
SPL Set ID f7be6506-4d20-401e-a0ff-02ad7c33158a
Established class (EPC) Lipid-based Polyene Antifungal; Polyene Antifungal
Chemical class Polyenes
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 1997-08-11
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance AMPHOTERICIN B
TE code (Orange Book) AB · RLD · RS

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

GPI-14 11000010401920
GPI class AmBisome
GCN Seq No 030773
GCN 07387
HICL code 012800
Ingredient (HICL) Amphotericin B Liposome
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W3
Therapeutic class — intermediate (HIC2) Antimycotics
HIC3 code W3A
Therapeutic class — specific (HIC3) Antifungal Antibiotics
AHFS code 08:14.28.00
AHFS class Polyene Antifungals
FDB label name AMBISOME 50 MG VIAL
FDB brand name Ambisome
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 030773
  • GCN: 07387
  • GPI-14 (Medi-Span): 11000010401920
  • HICL (First Databank): 012800
  • AHFS class code: 08:14.28.00
  • RxCUI (RxNorm): 967385
Why two NDCs? The FDA registers this code as 0469-3051-30 — a 4-4-2 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 labeler segment → 00469-3051-30. 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 Polyene Antifungal class.

Pharmacologic class Polyene Antifungal, Lipid-based Polyene Antifungal
Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Antibiotics, Antibiotics
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 AMBISOME 50 MG VIAL Ingredient Amphotericin B Liposome
📖 What it is MedlinePlus · NLM

Amphotericin B injection is used to treat serious and potentially life-threatening fungal infections. Amphotericin B injection is in a class of medications called antifungals. It works by slowing the growth of fungi that cause infection.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats serious, life-threatening fungal infections. The liposomal product AmBisome is also used for fever in people with low white blood cell counts who may have a fungal infect...
  • It is given slowly through a vein by healthcare professionals. Conventional amphotericin B infusions take about 2 to 6 hours, and you may get a small test dose first. Your team wil...
  • Chills, fever, nausea, vomiting, diarrhea and low potassium are common. AmBisome tends to cause fewer chills and kidney effects than conventional amphotericin B. Tell your nurse ri...
  • Amphotericin B can affect your kidneys and lower potassium, which can strain the heart. Your team watches your kidney function and electrolytes closely.
📖 Read our full Amphotericin B Injection guide →
1
Nutrient depletion considerations

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

🧪 Full Amphotericin B 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 $220.87 $2,760.82 / 12.5 ml
Medicare drug plans payPart D · Q2 2026 $313.58 $3,919.71 / 12.5 ml
Medicare Part B allowsASP · J0289 $19.845 / J0289 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)0469-3051-30
11-digit billing NDC00469-3051-30
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ0289
DescriptorINJECTION, AMPHOTERICIN B LIPOSOME, 10 MG
Billing units / pkg5 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 10 MG, so one package = 5 billing units.
Medicare Part B spend (2026 (Q1))$311,802 · 240 claims · $1,299.18 per claim (all NDCs under J0289)
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
00469-3051-30 You're viewing this Main listing 12.5 mL in 1 VIAL, SINGLE-DOSE 1997-08-11 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
AmBisome 50 mg/12.5mLthis 00469-3051-30 Astellas 12.5 ml — AB Discontinued —
Amphotericin B 50 mg 23155-0594-31 Heritage 1 vial — AB FDA listed —
Amphotericin B 50 mg/12.5mL 55150-0365-01 Eugia 1 vial — AB FDA listed —
Amphotericin B 50 mg 62756-0233-01 Sun 1 vial — AB FDA listed —
Amphotericin B 50 mg 62756-0954-01 Sun 1 vial — AB FDA listed —
Amphotericin B liposome 50 mg/12.5mL 67457-0926-50 Mylan 1 vial — AB 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

🏛️
1997
On the market since
Aug 1997
📍
2026
Currently FDA-listed
29 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.

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

  • UNII H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
  • UNII 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
  • UNII 4271ZA8WXO
    A synthetic phospholipid (fat-like compound) derived from or similar to those found in cell membranes. It acts as an emulsifier and surfactant, helping to mix water and oil-based ingredients together in the medicine.
  • UNII H1109Z9J4N
    A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
  • UNII U16QOD6C4E
    Sodium succinate hexahydrate is a salt form of succinic acid that contains water molecules. It functions as a buffer to help maintain stable pH levels in the medicine and may also act as a filler or tonicity agent.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerAstellas Pharma US, Inc.
Application holderASTELLAS PHARMA US INC
FDA applicationNDA050740 (NDA)
Labeler code00469
First marketedAug 1997
Product typeHuman Prescription Drug
Portfolio35 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 118 words ▾

INDICATIONS AND USAGE Am B isome is indicated for the following: • Empirical therapy for presumed fungal infection in febrile, neutropenic patients. • Treatment of Cryptococcal Meningitis in HIV-infected patients (see DESCRIPTION OF CLINICAL STUDIES ). • Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate. • Treatment of visceral leishmaniasis.

In immunocompromised patients with visceral leishmaniasis treated with Am B isome, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES ). See DOSAGE AND ADMINISTRATION for recommended doses by indication.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION AmBisome is not interchangeable or substitutable on a mg per mg basis with other amphotericin B products. Different amphotericin B products are not equivalent in terms of pharmacodynamics, pharmacokinetics and dosing. Am B isome should be administered by intravenous infusion, using a controlled infusion device, over a period of approximately 120 minutes.

An in-line membrane filter may be used for the intravenous infusion of Am B isome, provided THE MEAN PORE DIAMETER OF THE FILTER IS NOT LESS THAN

1.0MICRON . NOTE: An existing intravenous line must be flushed with 5% Dextrose Injection prior to infusion of AmBisome. If this is not feasible, AmBisome must be administered through a separate line.

Infusion time may be reduced to approximately 60 minutes in patients in whom the treatment is well-tolerated. If the patient experiences discomfort during infusion, the duration of infusion may be increased. The recommended initial dose of Am B isome for each indication for adult and pediatric patients is as follows: Indication Dose (mg/kg/day) Empirical therapy 3 Systemic fungal infections: Aspergillus Candida Cryptococcus 3 - 5 Cryptococcal meningitis in HIV-infected patients (see DESCRIPTION OF CLINICAL STUDIES ) 6 Dosing and rate of infusion should be individualized to the needs of the specific patient to ensure maximum efficacy while minimizing systemic toxicities or adverse events.

Doses recommended for visceral leishmaniasis are presented below: Visceral Leishmaniasis Dose (mg/kg/day) Immunocompetent patients 3 (days 1 - 5) and 3 on days 14, 21 Immunocompromised patients 4 (days 1 - 5) and 4 on days 10, 17, 24, 31, 38 For immunocompetent patients who do not achieve parasitic clearance with the recommended dose, a repeat course of therapy may be useful. For immunocompromised patients who do not clear parasites or who experience relapses, expert advice regarding further treatment is recommended.

For additional information, see DESCRIPTION OF CLINICAL STUDIES . Directions for Reconstitution, Filtration and Dilution Read This Entire Section Carefully Before Beginning Reconstitution Am B isome must be reconstituted using Sterile Water for Injection, USP (without a bacteriostatic agent). Vials of Am B isome containing 50 mg of amphotericin B are prepared as follows: Reconstitution 1.

Aseptically add 12 mL of Sterile Water for Injection, USP to each Am B isome vial to yield a preparation containing 4 mg amphotericin B/mL. CAUTION: DO NOT RECONSTITUTE WITH SALINE OR ADD SALINE TO THE RECONSTITUTED CONCENTRATION, OR MIX WITH OTHER DRUGS. The use of any solution other than those recommended, or the presence of a bacteriostatic agent in the solution, may cause precipitation of Am B isome.

2. Immediately after the addition of water, SHAKE THE VIAL VIGOROUSLY for 30 seconds to completely disperse the Am B isome. Am B isome forms a yellow, translucent suspension.

Visually inspect the vial for particulate matter and continue shaking until completely dispersed. Filtration and Dilution 3. Calculate the amount of reconstituted (4 mg/mL) Am B isome to be further diluted.

4. Withdraw this amount of reconstituted Am B isome into a sterile syringe. 5.

Attach the 5 micron filter provided to the syringe. Inject the syringe contents through the filter, into the appropriate amount of 5% Dextrose Injection (use only one filter per vial of Am B isome). 6.

Am B isome must be diluted with 5% Dextrose Injection to a final concentration of 1 to 2 mg/mL prior to administration. Lower concentrations (0.2 to 0.5 mg/mL) may be appropriate for infants and small children to provide sufficient volume for infusion. DISCARD PARTIALLY USED VIALS .

⛔ Contraindications 43 words ▾

CONTRAINDICATIONS Am B isome is contraindicated in those patients who have demonstrated or have a known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk.

⚠️ Warnings 42 words ▾

WARNINGS Anaphylaxis has been reported with amphotericin B deoxycholate and other amphotericin B-containing drugs, including Am B isome. If a severe anaphylactic reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusions of Am B isome.

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS The following adverse events are based on the experience of 592 adult patients (295 treated with Am B isome and 297 treated with amphotericin B deoxycholate) and 95 pediatric patients (48 treated with Am B isome and 47 treated with amphotericin B deoxycholate) in Study 94-0-002, a randomized double-blind, multi-center study in febrile, neutropenic patients. Am B isome and amphotericin B were infused over two hours. The incidence of common adverse events (incidence of 10% or greater) occurring with Am B isome compared to amphotericin B deoxycholate, regardless of relationship to study drug, is shown in the following table: Empirical Therapy Study 94-0-002 Common Adverse Events Adverse Event by Body System AmBisome N = 343 % Amphotericin B N = 344 % Body as a Whole Abdominal pain Asthenia Back pain Blood product transfusion reaction Chills Infection Pain Sepsis 19.8 13.1 12 18.4 47.5 11.1 14 14 21.8 10.8 7.3 18.6 75.9 9.3 12.8

11.3Cardiovascular System Chest pain Hypertension Hypotension Tachycardia 12 7.9 14.3 13.4 11.6 16.3 21.5

20.9Digestive System Diarrhea Gastrointestinal hemorrhage Nausea Vomiting 30.3 9.9 39.7 31.8 27.3 11.3 38.7

43.9Metabolic and Nutritional Disorders Alkaline phosphatase increased ALT (SGPT) increased AST (SGOT) increased Bilirubinemia BUN increased Creatinine increased Edema Hyperglycemia Hypernatremia Hypervolemia Hypocalcemia Hypokalemia Hypomagnesemia Peripheral edema 22.2 14.6 12.8 18.1 21 22.4 14.3 23 4.1 12.2 18.4 42.9 20.4 14.6 19.2 14 12.8 19.2 31.1 42.2 14.8 27.9 11 15.4 20.9 50.6 25.6

17.2Nervous System Anxiety Confusion Headache Insomnia 13.7 11.4 19.8 17.2 11 13.4 20.9

14.2Respiratory System Cough increased Dyspnea Epistaxis Hypoxia Lung disorder Pleural effusion Rhinitis 17.8 23 14.9 7.6 17.8 12.5 11.1 21.8 29.1 20.1 14.8 17.4 9.6 11 Skin and Appendages Pruritus Rash Sweating 10.8 24.8 7 10.2 24.4

10.8Urogenital System Hematuria 14 14 Am B isome was well tolerated. Am B isome had a lower incidence of chills, hypertension, hypotension, tachycardia, hypoxia, hypokalemia, and various events related to decreased kidney function as compared to amphotericin B deoxycholate. In pediatric patients (16 years of age or less) in this double-blind study, Am B isome compared to amphotericin B deoxycholate, had a lower incidence of hypokalemia (37% versus 55%), chills (29% versus 68%), vomiting (27% versus 55%), and hypertension (10% versus 21%).

Similar trends, although with a somewhat lower incidence, were observed in open-label, randomized Study 104-14 involving 205 febrile neutropenic pediatric patients (141 treated with Am B isome and 64 treated with amphotericin B deoxycholate). Pediatric patients appear to have more tolerance than older individuals for the nephrotoxic effects of amphotericin B deoxycholate. The following adverse events are based on the experience of 244 patients (202 adult and 42 pediatric patients) of whom 85 patients were treated with Am B isome 3 mg/kg, 81 patients were treated with Am B isome 5 mg/kg and 78 patients were treated with amphotericin B lipid complex 5 mg/kg in Study 97-0-034, a randomized, double-blind, multi-center study in febrile, neutropenic patients.

Am B isome and amphotericin B lipid complex were infused over two hours. The incidence of adverse events occurring in more than 10% of subjects in one or more arms, regardless of relationship to study drug, are summarized in the following table: Empirical Therapy Study 97-0-034 Common Adverse Events Adverse Event by Body System AmBisome 3 mg/kg/day N = 85 % AmBisome 5 mg/kg/day N = 81 % Amphotericin B Lipid Complex 5 mg/kg/day N = 78 % Body as a Whole Abdominal pain Asthenia Chills/rigors Sepsis Transfusion reaction 12.9 8.2 40 12.9 10.6 9.9 6.2 48.1 7.4 8.6 11.5 11.5 89.7 11.5

5.1Cardiovascular System Chest pain Hypertension Hypotension Tachycardia 8.2 10.6 10.6 9.4 11.1 19.8 7.4 18.5 6.4 23.1 19.2

23.1Digestive System Diarrhea Nausea Vomiting 15.3 25.9 22.4 17.3 29.6 25.9 14.1 37.2 30.… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

Drug Interactions No formal clinical studies of drug interactions have been conducted with Am B isome; however, the following drugs are known to interact with amphotericin B and may interact with Am B isome: Antineoplastic Agents Concurrent use of antineoplastic agents may enhance the potential for renal toxicity, bronchospasm, and hypotension. Antineoplastic agents should be given concomitantly with caution. Corticosteroids and Corticotropin (ACTH) Concurrent use of corticosteroids and ACTH may potentiate hypokalemia, which could predispose the patient to cardiac dysfunction.

If used concomitantly, serum electrolytes and cardiac function should be closely monitored. Digitalis Glycosides Concurrent use may induce hypokalemia and may potentiate digitalis toxicity. When administered concomitantly, serum potassium levels should be closely monitored.

Flucytosine Concurrent use of flucytosine may increase the toxicity of flucytosine by possibly increasing its cellular uptake and/or impairing its renal excretion. Azoles (e.g., ketoconazole, miconazole, clotrimazole, fluconazole, etc.) In vitro and in vivo animal studies of the combination of amphotericin B and imidazoles suggest that imidazoles may induce fungal resistance to amphotericin B. Combination therapy should be administered with caution, especially in immunocompromised patients.

Leukocyte Transfusions Acute pulmonary toxicity has been reported in patients simultaneously receiving intravenous amphotericin B and leukocyte transfusions. Other Nephrotoxic Medications Concurrent use of amphotericin B and other nephrotoxic medications may enhance the potential for drug-induced renal toxicity. Intensive monitoring of renal function is recommended in patients requiring any combination of nephrotoxic medications.

Skeletal Muscle Relaxants Amphotericin B-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants (e.g. tubocurarine) due to hypokalemia. When administered concomitantly, serum potassium levels should be closely monitored.

🧒 Pediatric Use 125 words ▾

Pediatric Use Pediatric patients, age 1 month to 16 years, with presumed fungal infection (empirical therapy), confirmed systemic fungal infections or with visceral leishmaniasis have been successfully treated with Am B isome. In studies which included 302 pediatric patients administered Am B isome, there was no evidence of any differences in efficacy or safety of Am B isome compared to adults. Since pediatric patients have received Am B isome at doses comparable to those used in adults on a per kilogram body weight basis, no dosage adjustment is required in this population.

Safety and effectiveness in pediatric patients below the age of one month have not been established (See DESCRIPTION OF CLINICAL STUDIES - Empirical Therapy in Febrile Neutropenic Patients and DOSAGE AND ADMINISTRATION ).

🧓 Geriatric Use 48 words ▾

Elderly Patients Experience with Am B isome in the elderly (65 years or older) comprised 72 patients. It has not been necessary to alter the dose of Am B isome for this population. As with most other drugs, elderly patients receiving Am B isome should be carefully monitored.

🆘 Overdosage 80 words ▾

OVERDOSAGE The toxicity of Am B isome due to overdose has not been defined. Repeated daily doses up to 10 mg/kg in pediatric patients and 15 mg/kg in adult patients have been administered in clinical trials with no reported dose-related toxicity. Management If overdosage should occur, cease administration immediately.

Symptomatic supportive measures should be instituted. Particular attention should be given to monitoring renal function. Hemodialysis or peritoneal dialysis do not appear to significantly affect the elimination of Am B isome.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Pharmacokinetics The assay used to measure amphotericin B in the serum after administration of Am B isome does not distinguish amphotericin B that is complexed with the phospholipids of Am B isome from amphotericin B that is uncomplexed. The pharmacokinetic profile of amphotericin B after administration of Am B isome is based upon total serum concentrations of amphotericin B. The pharmacokinetic profile of amphotericin B was determined in febrile neutropenic cancer and bone marrow transplant patients who received 1-2 hour infusions of 1 to 5 mg/kg/day Am B isome for 3 to 20 days.

The pharmacokinetics of amphotericin B after administration of Am B isome is nonlinear such that there is a greater than proportional increase in serum concentrations with an increase in dose from 1 to 5 mg/kg/day. The pharmacokinetic parameters of total amphotericin B (mean ± SD) after the first dose and at steady state are shown in the table below. Pharmacokinetic Parameters of AmBisome Dose 1 mg/kg/day 2.5 mg/kg/day 5 mg/kg/day Day 1 n = 8 Last n = 7 1 n = 7 Last n = 7 1 n = 12 Last n = 9 Parameters C max (mcg/mL) 7.3 ± 3.8 12.2 ± 4.9 17.2 ± 7.1 31.4 ± 17.8 57.6 ± 21 83 ±

35.2AUC 0-24 (mcg•hr/mL) 27 ± 14 60 ± 20 65 ± 33 197 ± 183 269 ± 96 555 ± 311 t ½ (hr) 10.7 ± 6.4 7 ± 2.1 8.1 ± 2.3 6.3 ± 2 6.4 ± 2.1 6.8 ±

2.1V ss (L/kg) 0.44 ± 0.27 0.14 ± 0.05 0.40 ± 0.37 0.16 ± 0.09 0.16 ± 0.10 0.10 ±

0.07Cl (mL/hr/kg) 39 ± 22 17 ± 6 51 ± 44 22 ± 15 21 ± 14 11 ± 6 Distribution Based on total amphotericin B concentrations measured within a dosing interval (24 hours) after administration of Am B isome, the mean half-life was 7-10 hours. However, based on total amphotericin B concentration measured up to 49 days after dosing of Am B isome, the mean half-life was 100-153 hours. The long terminal elimination half-life is probably a slow redistribution from tissues.

Steady state concentrations were generally achieved within 4 days of dosing. Although variable, mean trough concentrations of amphotericin B remained relatively constant with repeated administration of the same dose over the range of 1 to 5 mg/kg/day, indicating no significant drug accumulation in the serum. Metabolism The metabolic pathways of amphotericin B after administration of Am B isome are not known.

Excretion The mean clearance at steady state was independent of dose. The excretion of amphotericin B after administration of Am B isome has not been studied. Pharmacokinetics in Special Populations Renal Impairment The effect of renal impairment on the disposition of amphotericin B after administration of Am B isome has not been studied.

However, Am B isome has been successfully administered to patients with pre-existing renal impairment (see DESCRIPTION OF CLINICAL STUDIES ). Hepatic Impairment The effect of hepatic impairment on the disposition of amphotericin B after administration of Am B isome is not known. Pediatric and Elderly Patients The pharmacokinetics of amphotericin B after administration of Am B isome in pediatric and elderly patients has not been studied; however, Am B isome has been used in pediatric and elderly patients (see DESCRIPTION OF CLINICAL STUDIES ).

Gender and Ethnicity The effect of gender or ethnicity on the pharmacokinetics of amphotericin B after administration of Am B isome is not known.

📦 How Supplied / Storage and Handling 25 words ▾

HOW SUPPLIED Am B isome for Injection is available as an individual carton (NDC 0469-3051-30). Each carton contains one pre-packaged, disposable sterile 5 micron filter.

📋 Description ~2 min read ▾

DESCRIPTION Am B isome ® for Injection is a sterile, non-pyrogenic lyophilized product for intravenous infusion. Each vial contains amphotericin B 50 milligrams (mg), intercalated into a liposomal membrane consisting of alpha tocopherol approximately 0.64 mg; cholesterol 52 mg; distearoyl phosphatidylglycerol sodium salt 84 mg; hydrogenated soy phosphatidylcholine 213 mg, together with disodium succinate hexahydrate 27 mg; and sucrose 900 mg. Am B isome may also contain hydrochloric acid and/or sodium hydroxide as pH adjusters.

Following reconstitution with Sterile Water for Injection, USP, the resulting pH of the suspension is between 5-6. Am B isome is a true single bilayer liposomal drug delivery system. Liposomes are closed, spherical vesicles created by mixing specific proportions of amphophilic substances such as phospholipids and cholesterol so that they arrange themselves into multiple concentric bilayer membranes when hydrated in aqueous solutions.

Single bilayer liposomes are then formed by microemulsification of multilamellar vesicles using a homogenizer. Am B isome consists of these unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Due to the nature and quantity of amphophilic substances used, and the lipophilic moiety in the amphotericin B molecule, the drug is an integral part of the overall structure of the Am B isome liposomes.

Am B isome contains true liposomes that are less than 100 nm in diameter. A schematic depiction of the liposome is presented below. Note: Liposomal encapsulation or incorporation into a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated drug or non-lipid associated drug.

In addition, different liposomal or lipid-complex products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect the functional properties of these drug products. Amphotericin B is a macrocyclic, polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus .

Amphotericin B is designated chemically as: [1R-(1R*,3S*,5R*,6R*,9R*,11R*,15S*,16R*,17R*,18S*,19E,21E,23E,25E,27E,29E,31E,33R*,35S*,36R*,37S*)]-33-[(3-Amino-3,6-dideoxy-β-D-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid (CAS No. 1397-89-3). Amphotericin B has a molecular formula of C 47 H 73 NO 17 and a molecular weight of 924.09.

The structure of amphotericin B is shown below: description Molecular structure of amphotericin B

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General As with any amphotericin B-containing product the drug should be administered by medically trained personnel. During the initial dosing period, patients should be under close clinical observation. Am B isome has been shown to be significantly less toxic than amphotericin B deoxycholate; however, adverse events may still occur.

Laboratory Tests Patient management should include laboratory evaluation of renal, hepatic and hematopoietic function, and serum electrolytes (particularly magnesium and potassium). Drug-Laboratory Interactions: Serum phosphate false elevation False elevations of serum phosphate may occur when samples from patients receiving Am B isome are analyzed using the PHOSm assay (e.g. used in Beckman Coulter analyzers including the Synchron LX20). This assay is intended for the quantitative determination of inorganic phosphorus in human serum, plasma or urine samples.

Drug Interactions No formal clinical studies of drug interactions have been conducted with Am B isome; however, the following drugs are known to interact with amphotericin B and may interact with Am B isome: Antineoplastic Agents Concurrent use of antineoplastic agents may enhance the potential for renal toxicity, bronchospasm, and hypotension. Antineoplastic agents should be given concomitantly with caution. Corticosteroids and Corticotropin (ACTH) Concurrent use of corticosteroids and ACTH may potentiate hypokalemia, which could predispose the patient to cardiac dysfunction.

If used concomitantly, serum electrolytes and cardiac function should be closely monitored. Digitalis Glycosides Concurrent use may induce hypokalemia and may potentiate digitalis toxicity. When administered concomitantly, serum potassium levels should be closely monitored.

Flucytosine Concurrent use of flucytosine may increase the toxicity of flucytosine by possibly increasing its cellular uptake and/or impairing its renal excretion. Azoles (e.g., ketoconazole, miconazole, clotrimazole, fluconazole, etc.) In vitro and in vivo animal studies of the combination of amphotericin B and imidazoles suggest that imidazoles may induce fungal resistance to amphotericin B. Combination therapy should be administered with caution, especially in immunocompromised patients.

Leukocyte Transfusions Acute pulmonary toxicity has been reported in patients simultaneously receiving intravenous amphotericin B and leukocyte transfusions. Other Nephrotoxic Medications Concurrent use of amphotericin B and other nephrotoxic medications may enhance the potential for drug-induced renal toxicity. Intensive monitoring of renal function is recommended in patients requiring any combination of nephrotoxic medications.

Skeletal Muscle Relaxants Amphotericin B-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants (e.g. tubocurarine) due to hypokalemia. When administered concomitantly, serum potassium levels should be closely monitored. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies in animals have been performed to evaluate carcinogenic potential of Am B isome.

Am B isome has not been tested to determine its mutagenic potential. A Segment I Reproductive Study in rats found an abnormal estrous cycle (prolonged diestrus) and decreased number of corpora lutea in the high-dose groups (10 and 15 mg/kg, doses equivalent to human doses of 1.6 and 2.4 mg/kg based on body surface area considerations). Am B isome did not affect fertility or days to copulation.

There were no effects on male reproductive function. Pregnancy There have been no adequate and well-controlled studies of Am B isome in pregnant women. Systemic fungal infections have been successfully treated in pregnant women with amphotericin B deoxycholate, but the number of cases reported has been small.

Segment II studies in both rats and rabbits have concluded that Am B isome had no teratogenic potential in these species. In rats, the maternal non-toxic dose of Am B isome was estimat… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 60 words ▾

Nursing Mothers Many drugs are excreted in human milk; however, it is not known whether Am B isome is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or whether to discontinue the drug, taking into account the importance of the drug to the mother.

🔬 Clinical Studies ~3 min read ▾

DESCRIPTION OF CLINICAL STUDIES Eleven clinical studies supporting the efficacy and safety of Am B isome were conducted. This clinical program included both controlled and uncontrolled studies. These studies, which involved 2,171 patients, included patients with confirmed systemic mycoses, empirical therapy, and visceral leishmaniasis.

Nineteen hundred and forty-six (1946) episodes were evaluable for efficacy, of which 1,280 (302 pediatric and 978 adults) were treated with Am B isome. Three controlled empirical therapy trials compared the efficacy and safety of Am B isome to amphotericin B. One of these studies was conducted in a pediatric population, one in adults, and a third in patients aged 2 years or more.

In addition, a controlled empirical therapy trial comparing the safety of Am B isome to Abelcet ® (amphotericin B lipid complex) was conducted in patients aged 2 years or more. One controlled trial compared the efficacy and safety of Am B isome to amphotericin B in HIV patients with cryptococcal meningitis. One compassionate use study enrolled patients who had failed amphotericin B deoxycholate therapy or who were unable to receive amphotericin B deoxycholate because of renal insufficiency.

Empirical Therapy in Febrile Neutropenic Patients Study 94-0-002, a randomized, double-blind, comparative multi-center trial, evaluated the efficacy of Am B isome (1.5-6 mg/kg/day) compared with amphotericin B deoxycholate (0.3-1.2 mg/kg/day) in the empirical treatment of 687 adult and pediatric neutropenic patients who were febrile despite having received at least 96 hours of broad spectrum antibacterial therapy. Therapeutic success required (a) resolution of fever during the neutropenic period, (b) absence of an emergent fungal infection, (c) patient survival for at least 7 days post therapy, (d) no discontinuation of therapy due to toxicity or lack of efficacy, and (e) resolution of any study-entry fungal infection.

The overall therapeutic success rates for Am B isome and the amphotericin B deoxycholate were equivalent. Results are summarized in the following table. Note: The categories presented below are not mutually exclusive.

Empirical Therapy in Febrile Neutropenic Patients: Randomized, Double-Blind Study in 687 Patients AmBisome 3 mg/kg/day Amphotericin B 0.6 mg/kg/day Number of patients receiving at least one dose of study drug 343 344 Overall Success 171 (49.9%) 169 (49.1%) Fever resolution during neutropenic period 199 (58%) 200 (58.1%) No treatment-emergent fungal infection 300 (87.5%) 301 (87.7%) Survival through 7 days post study drug 318 (92.7%) 308 (89.5%) Study drug not prematurely discontinued due to toxicity or lack of efficacy* 294 (85.7%) 280 (81.4%) * 8 and 10 patients, respectively, were treated as failures due to premature discontinuation alone.

This therapeutic equivalence had no apparent relationship to the use of prestudy antifungal prophylaxis or concomitant granulocytic colony-stimulating factors. The incidence of mycologically-confirmed, and clinically-diagnosed, emergent fungal infections are presented in the following table. Am B isome and amphotericin B were found to be equivalent with respect to the total number of emergent fungal infections.

Empirical Therapy in Febrile Neutropenic Patients: Emergent Fungal Infections AmBisome 3 mg/kg/day Amphotericin B 0.6 mg/kg/day Number of patients receiving at least one dose of study drug 343 344 Mycologically-confirmed fungal infection 11 (3.2%) 27 (7.8%) Clinically-diagnosed fungal infection 32 (9.3%) 16 (4.7%) Total emergent fungal infections 43 (12.5%) 43 (12.5%) Mycologically-confirmed fungal infections at study entry were cured in 8 of 11 patients in the Am B isome group and 7 of 10 in the amphotericin B group.

Study 97-0-034, a randomized, double-blind, comparative multi-center trial, evaluated the safety of Am B isome (3 and 5 mg/kg/day) compared with amphotericin B lipid complex (5 mg/kg/day) in the empirical treatment of 202 adult and 42 pediatric ne… [Excerpted — this section continues on DailyMed.]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 96 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies in animals have been performed to evaluate carcinogenic potential of Am B isome. Am B isome has not been tested to determine its mutagenic potential. A Segment I Reproductive Study in rats found an abnormal estrous cycle (prolonged diestrus) and decreased number of corpora lutea in the high-dose groups (10 and 15 mg/kg, doses equivalent to human doses of 1.6 and 2.4 mg/kg based on body surface area considerations).

Am B isome did not affect fertility or days to copulation. There were no effects on male reproductive function.

📄 Package Label / Principal Display Panel 23 words ▾

Principal Display Panel AmBisome (amphotericin B) liposome for injection equivalent to 50 mg amphotericin B For Intravenous Infusion Only Single-Use Vial Ambisome Carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
460
Units reimbursed last 4 qtrs
3.6K
Gross reimbursed last 4 qtrs
$785.4K
Avg / prescription
$1,707.39
Avg / unit
$220.87
Latest quarter Q4 2025
28Rx
Fee-for-service vs managed care ⓘ
28% FFS 72% MCO
Fee-for-service · 130 Rx Managed care · 330 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: 108 units · 1.1 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 108 units · 3.4 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 283 units · 2.4 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 50 units · 0.5 per 100k residents NJ Massachusetts: no data reported MA California: 1,895 units · 4.9 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 112 units · 5.3 per 100k residents 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: 11 units · 0.8 per 100k residents HI Texas: 989 units · 3.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.55.3
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 New Mexico 5.3 /100k
2 California 4.9 /100k
3 Iowa 3.4 /100k
4 Texas 3.2 /100k
5 Ohio 2.4 /100k
6 Michigan 1.1 /100k
7 Hawaii 0.8 /100k
8 New Jersey 0.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Ambisome — 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 Ambisome. 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
$25K
Claims incl. refills
31
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$807.72
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 Amphotericin B — the ingredient across all brands.

Top reported reactions

Condition Aggravated816
Pyrexia796
Multiple Organ Dysfunction Syndrome530
Acute Kidney Injury529
Sepsis481
Febrile Neutropenia470
Neutropenia437

Age at onset

Neonate89
Infant73
Child276
Adolescent109
Adult1,125
Elderly408

Reporter sex

14,763 reports
Male · 60%
Female · 40%
Unknown · 0%

Serious outcomes

Hospitalization6,303
Death5,701
Life-threatening1,931
Disabling198
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,493 727
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 No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
Astellas Pharma US, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J0289 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.
← 00469-3016-01 · Astellas 00469-3250-10 · Astellas →
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.