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TREANDA Bendamustine Hydrochloride 25 mg/5mL Injection, Powder, Lyophilized, For Solution — NDC 63459-390-08 (Billing 63459-0390-08)

by Cephalon, LLC · 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE

This is a package of TREANDA Bendamustine Hydrochloride 25 mg/5mL Injection, Powder, Lyophilized, For Solution from Cephalon, LLC, marketed since Jan 2010 and currently FDA-listed. It is this product's only package size.

NDC 63459-0390-08
🏷️ FDA NDC (as labeled) 63459-390-08 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⚠ On shortage ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 63459-390-08 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63459 labeler · 390 product · 08 package
Package marketed since
Jan 5, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6345939008 6
Medicaid fills, this package
28 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026
⚠️
Active FDA shortage. Bendamustine Hydrochloride Injection, Solution is currently reported in shortage by the FDA. Shortage details →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63459-390-08
Product NDC 63459-390
11-digit billing NDC 63459039008
NCPDP billing unit EA — each (per item)
Application # NDA022249
SPL Set ID 6f14f826-ae33-48f7-8a5a-413412030c2d
Established class (EPC) Alkylating Drug
Mechanism of action Alkylating Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-01-05
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance BENDAMUSTINE HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS

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

GCN Seq No 036745
GCN 07182
HICL code 016785
Ingredient (HICL) Bendamustine Hcl
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1A
Therapeutic class — specific (HIC3) Antineoplastic - Alkylating Agents
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name TREANDA 25 MG VIAL
FDB brand name Treanda
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 036745
  • GCN: 07182
  • HICL (First Databank): 016785
  • AHFS class code: 10:00.00.00
Why two NDCs? The FDA registers this code as 63459-390-08 — 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 → 63459-0390-08. 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.

Clinical

Label name TREANDA 25 MG VIAL Ingredient Bendamustine Hcl
📖 What it is MedlinePlus · NLM

Bendamustine injection is used to treat chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells). Bendamustine injection is also used to treat a type of non-Hodgkins lymphoma (NHL: cancer that begins in a type of white blood cell that normally fights infection) that is slow spreading, but has continued to worsen during or after treatment with another medication. Bendamustine is in a class of medications called alkylating agents. It works by killing existing cancer cells and limiting the growth of new cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of rituximab. It is a chemotherapy drug given...
  • A healthcare professional gives it as an IV infusion on two days in a row of each cycle. How long each infusion takes depends on the product. Your team will schedule everything and...
  • Nausea, vomiting, tiredness and fever are common. Low blood counts are also common, and your team will monitor them. Diarrhea, constipation, rash and headache can happen too.
  • Call right away for fever, chills or other signs of infection. Also call for rash, itching or swelling during or after an infusion, blistering or peeling skin, redness or pain at t...
📖 Read our full Bendamustine guide →
1
Nutrient depletion considerations

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

🧪 Full Bendamustine Hydrochloride 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 $325.10 $1,625.49 / 5 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9033 $2.960 / J9033 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)63459-390-08
11-digit billing NDC63459-0390-08
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9033
DescriptorInjection, bendamustine hcl (treanda), 1 mg
Billing units / pkg25 units
How the units are derivedThis package is 1; the HCPCS unit is 1 MG, so one package = 25 billing units.
Medicare Part B spend (2026 (Q1))$211,335 · 507 claims · $416.83 per claim (all NDCs under J9033)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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
63459-0390-08 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE 2010-01-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
bendamustine hydrochloride 25 mg/5mL 16729-0250-03 Accord 1 vial — AP FDA listed —
Bendamustine Hydrochloride 25 mg/5mL 55150-0391-01 Eugia 1 vial — AP FDA listed —
Treanda 25 mg/5mLthis 63459-0390-08 Cephalon, 1 vial — AP FDA listed —
Bendamustine 25 mg/5mL 71288-0102-10 Meitheal 1 vial — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2009
First FDA approval
May 2009
📍
2026
Currently FDA-listed
17 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🔒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.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 1, 2009 AP TE-rated RLD RS ⏳ ~4.5 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8445524 — drug substance (U-1402)
US 8791270 — method of use (U-1542)
US 8791270 — method of use (U-1542)
US 8883836 — method of use (U-1402)
US 9533955 — method of use (U-1952)
US 9533955 — method of use (U-1952)
US 8791270 — method of use (U-1542)
US 8445524 — drug substance (U-1402)
US 8791270 — method of use (U-1542)
US 8669279 — method of use (U-1402)
US 8344006 — method of use (U-1402)
US 9533955 — method of use (U-1949)
US 9533955 — method of use (U-1949)
US 8344006 — method of use (U-1402)
US 8669279 — method of use (U-1402)
US 8883836 — method of use (U-1402)
US 8445524 — drug substance
US 8609863 — drug product
US 8895756 — drug product
US 8609863 — drug product
US 8436190 — drug product
US 8445524 — drug substance
US 8436190 — drug product
US 8895756 — drug product
US 8436190*PED — drug product
US 8445524*PED — drug product
US 8436190*PED — drug product
US 8445524*PED — drug product
US 8883836*PED — drug product
US 8669279*PED — drug product
US 8883836*PED — drug product
US 8669279*PED — drug product
US 8791270*PED — drug product
US 8791270*PED — drug product
US 8791270*PED — drug product
US 8791270*PED — drug product
US 8344006*PED — drug product
US 8445524*PED — drug product
US 8445524*PED — drug product
US 8344006*PED — drug product
US 8609863*PED — drug product
US 8609863*PED — drug product
US 8895756*PED — drug product
US 8895756*PED — drug product
US 9533955*PED — drug product
US 9533955*PED — drug product
2009 2011 2013 2015 2017 2019 2021 2023 2025 2027 2029 2031
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (46)
PatentTypeUse codeExpires
US 8445524 ↗ Drug substance U-1402 Mar 26, 2029
US 8791270 ↗ Method of use U-1542 Jan 12, 2026
US 8791270 ↗ Method of use U-1542 Jan 12, 2026
US 8883836 ↗ Method of use U-1402 Mar 26, 2029
US 9533955 ↗ Method of use U-1952 Mar 26, 2029
US 9533955 ↗ Method of use U-1952 Mar 26, 2029
US 8791270 ↗ Method of use U-1542 Jan 12, 2026
US 8445524 ↗ Drug substance U-1402 Mar 26, 2029
US 8791270 ↗ Method of use U-1542 Jan 12, 2026
US 8669279 ↗ Method of use U-1402 Mar 26, 2029
US 8344006 ↗ Method of use U-1402 Sep 23, 2029
US 9533955 ↗ Method of use U-1949 Mar 26, 2029
US 9533955 ↗ Method of use U-1949 Mar 26, 2029
US 8344006 ↗ Method of use U-1402 Sep 23, 2029
US 8669279 ↗ Method of use U-1402 Mar 26, 2029
US 8883836 ↗ Method of use U-1402 Mar 26, 2029
US 8445524 ↗ Drug substance — Mar 26, 2029
US 8609863 ↗ Drug product — Jan 12, 2026
US 8895756 ↗ Drug product — Jan 12, 2026
US 8609863 ↗ Drug product — Jan 12, 2026
US 8436190 ↗ Drug product — Oct 26, 2030
US 8445524 ↗ Drug substance — Mar 26, 2029
US 8436190 ↗ Drug product — Oct 26, 2030
US 8895756 ↗ Drug product — Jan 12, 2026
US 8436190*PED ↗ Drug product — Apr 26, 2031
US 8445524*PED ↗ Drug product — Sep 26, 2029
US 8436190*PED ↗ Drug product — Apr 26, 2031
US 8445524*PED ↗ Drug product — Sep 26, 2029
US 8883836*PED ↗ Drug product — Sep 26, 2029
US 8669279*PED ↗ Drug product — Sep 26, 2029
US 8883836*PED ↗ Drug product — Sep 26, 2029
US 8669279*PED ↗ Drug product — Sep 26, 2029
US 8791270*PED ↗ Drug product — Jul 12, 2026
US 8791270*PED ↗ Drug product — Jul 12, 2026
US 8791270*PED ↗ Drug product — Jul 12, 2026
US 8791270*PED ↗ Drug product — Jul 12, 2026
US 8344006*PED ↗ Drug product — Mar 23, 2030
US 8445524*PED ↗ Drug product — Sep 26, 2029
US 8445524*PED ↗ Drug product — Sep 26, 2029
US 8344006*PED ↗ Drug product — Mar 23, 2030
US 8609863*PED ↗ Drug product — Jul 12, 2026
US 8609863*PED ↗ Drug product — Jul 12, 2026
US 8895756*PED ↗ Drug product — Jul 12, 2026
US 8895756*PED ↗ Drug product — Jul 12, 2026
US 9533955*PED ↗ Drug product — Sep 26, 2029
US 9533955*PED ↗ Drug product — Sep 26, 2029
Common questions
Is there a generic version of TREANDA 25 MG VIAL?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for TREANDA 25 MG VIAL. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

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

🧪 Avoiding an ingredient? See Bendamustine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerCephalon, LLC
Application holderCEPHALON INC
FDA applicationNDA022249 (NDA)
Labeler code63459
First marketedJan 2010
Product typeHuman Prescription Drug
Portfolio19 products on file

More NDCs from Cephalon, LLC labeler code 63459

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. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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
28
Units reimbursed last 4 qtrs
147
Gross reimbursed last 4 qtrs
$47.8K
Avg / prescription
$1,706.77
Avg / unit
$324.66
Latest quarter Q4 2025
16Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 28 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 116 units · 1.5 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.51.5
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 Washington 1.5 /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 Treanda — 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 Treanda. 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
$289.9K
Claims incl. refills
36
Beneficiaries
16
Spend / beneficiary
$18,120.35
Spend / claim
$8,053.49
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 Bendamustine Hydrochloride — the ingredient across all brands.

Top reported reactions

Pyrexia578
Disease Progression513
Covid-19411
Febrile Neutropenia379
Malignant Neoplasm Progression361
Neutropenia359
Neutrophil Count Decreased358

Age at onset

Child4
Adolescent8
Adult720
Elderly1,095

Reporter sex

8,443 reports
Male · 60%
Female · 40%
Unknown · 0%

Serious outcomes

Hospitalization3,274
Death1,603
Life-threatening463
Disabling105
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,486 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Cephalon, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cephalon, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9033 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.
← 63459-0348-04 · Teva 63459-0391-20 · Cephalon, →
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.