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Ivosidenib 1 kg/kg Powder, 20 kg — NDC 54864-720-15 (Billing 54864-0720-15)

by DOTTIKON EXCLUSIVE SYNTHESIS AG · 20 kg in 1 DRUM

This is a package of 20 kg of Ivosidenib 1 kg/kg Powder from DOTTIKON EXCLUSIVE SYNTHESIS AG, marketed since Jul 2018 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 54864-0720-15
🏷️ FDA NDC (as labeled) 54864-720-15 billing pads the product segment with a zero
This package
Contains20 kg Pack sizes2 compare ↓
Main listing for product 54864-720 · Also comes in: 20 kg 54864-720-63
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

NDC database record

One package, one record: these facts belong to NDC 54864-720-15 alone.

Record
FDA NDC Directory package listing · Bulk ingredient
Code segments
54864 labeler · 720 product · 15 package
Package marketed since
Jul 20, 2018
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5486472015 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54864-720-15
Product NDC 54864-720
11-digit billing NDC 54864072015
SPL Set ID d091edd9-324c-46b1-e053-2a95a90a4a48
DEA schedule Non-controlled
Marketing category BULK INGREDIENT
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-07-20
Dosage form POWDER
Substance IVOSIDENIB
Why two NDCs? The FDA registers this code as 54864-720-15 — 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 → 54864-0720-15. 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

📗 Our plain-language guide HelloPharmacist
  • It treats adults whose cancer has an IDH1 mutation. That includes certain cases of AML, MDS and previously treated cholangiocarcinoma. Your doctor confirms the mutation with a test...
  • Take your Tibsovo tablet once a day at about the same time. You can take it with or without food, but avoid a high-fat meal. Swallow it whole and do not crush, split or chew it.
  • If you vomit a dose, do not take another. Wait for your next one. If you miss a dose, take it as soon as you can, as long as it is at least 12 hours before the next one. Never take...
  • Diarrhea, nausea, tiredness, swelling, joint or muscle aches and a lower appetite are common. Call your team promptly if you have fever, trouble breathing, rapid weight gain, swell...
📖 Read our full Ivosidenib guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer gPer 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.
Try another pack size: 20 kg
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
54864-0720-15 You're viewing this Main listing 20 kg in 1 DRUM — — Active
54864-0720-63 54864-720-63 20 kg in 1 DRUM — — Active

Pack size FAQ

What quantity is in this package?
This package contains 20 kg — 20 kg in 1 drum.
How does this package differ from NDC 54864-0720-63?
Both are Ivosidenib 1 kg/kg Powder — the drug itself is identical. This page's package is the 20 kg one, while NDC 54864-0720-63 is the 20 kg package.
What NDC number is used to bill for this package of Ivosidenib 1 kg/kg Powder?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ivosidenib 1 kg/kgthis 54864-0720-15 DOTTIKON 20 kg — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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

LabelerDOTTIKON EXCLUSIVE SYNTHESIS AG
Labeler code54864
First marketedJul 2018
Product typeBulk Ingredient
Portfolio16 products on file

More NDCs from DOTTIKON EXCLUSIVE SYNTHESIS AG labeler code 54864

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 FDA label FDA SPL

The complete FDA label for this product, 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 ↗

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

Medicare Part D (outpatient prescription) spending for Tibsovo (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Tibsovo. 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
$90.52M
Claims incl. refills
2.8K
Beneficiaries
1.2K
Spend / beneficiary
$78,436.66
Spend / claim
$31,905.50
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 Ivosidenib — the ingredient across all brands.

Top reported reactions

Fatigue169
Nausea121
Diarrhoea119
Differentiation Syndrome93
Disease Progression88
Malignant Neoplasm Progression79
Electrocardiogram Qt Prolonged76

Age at onset

Adolescent1
Adult27
Elderly57

Reporter sex

2,057 reports
Male · 51%
Female · 48%
Unknown · 0%

Serious outcomes

Hospitalization642
Death207
Life-threatening52
Disabling6
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 431 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

Bulk ingredient (not a finished retail product)

This is a bulk ingredient listing — not a retail prescription package

Ivosidenib 1 kg/kg POWDER is listed with FDA as a bulk ingredient (a drug substance supplied for further manufacturing or licensed pharmacy compounding). It is not a finished product a patient would receive at a retail pharmacy, so consumer-style information — a patient label, retail pricing, package photos — generally does not exist for this NDC. The listing identifies the substance and package for supply-chain and regulatory purposes.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — 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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Bulk Ingredient". Products approved under an application carry an NDA, ANDA, or BLA number.
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.
Can I get this product filled at a pharmacy?
Not as listed here. A bulk ingredient NDC identifies drug substance supplied for manufacturing or licensed compounding — it is not a finished, dispensable package. A pharmacy prescription would involve a finished product with its own NDC.
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 DOTTIKON EXCLUSIVE SYNTHESIS AG. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 20 kg (54864-0720-63). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
DOTTIKON EXCLUSIVE SYNTHESIS AG 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.
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.
← 54864-0674-15 · DOTTIKON 54864-0843-15 · DOTTIKON →
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.