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Gomekli mirdametinib 2 mg Capsule, 84-count — NDC 82448-260-84 (Billing 82448-0260-84)

by SpringWorks Therapeutics, Inc. · 84 CAPSULE in 1 BOTTLE

This is a package of 84 capsules of Gomekli mirdametinib 2 mg Capsule from SpringWorks Therapeutics, Inc., marketed since Feb 2025 and currently FDA-listed.

NDC 82448-0260-84
🏷️ FDA NDC (as labeled) 82448-260-84 billing pads the product segment with a zero
This package
Contains84-count Medicaid pays$425.80 / unit · 12 mo Per package$35,767.03 / 84 capsules · Medicaid Pack sizes2 compare ↓
Also priced by: Part D plans $452.01/unit — full pricing hub ↓
Product page 82448-0260-42 Also comes in: 42 capsules 82448-260-42
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 82448-260-84 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
82448 labeler · 260 product · 84 package
Package marketed since
Feb 11, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
84 EA per package
Barcode (UPC-A, from the NDC)
3 8244826084 1
Medicaid fills, this package
102 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82448-260-84
Product NDC 82448-260
11-digit billing NDC 82448026084
NCPDP billing unit EA — each (per item)
Application # NDA219389
SPL Set ID 5132f76b-c3da-4831-833c-c48cb8eee26a
Established class (EPC) Kinase Inhibitor
Mechanism of action Mitogen-Activated Protein Kinase Kinase 1 Inhibitors; Mitogen-Activated Protein Kinase Kinase 2 Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-11
Route ORAL
Dosage form CAPSULE
Substance MIRDAMETINIB

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

GCN Seq No 087226
GCN 57082
HICL code 050277
Ingredient (HICL) Mirdametinib
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V3
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs (Continued 1)
HIC3 code V3U
Therapeutic class — specific (HIC3) Antineoplastic - Mek Kinase Inhibitors
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name GOMEKLI 2 MG CAPSULE
FDB brand name Gomekli
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 087226
  • GCN: 57082
  • HICL (First Databank): 050277
  • AHFS class code: 10:00.00.00
Why two NDCs? The FDA registers this code as 82448-260-84 — 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 → 82448-0260-84. 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 GOMEKLI 2 MG CAPSULE Ingredient Mirdametinib

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $425.80 $35,767.03 / 84 capsules
Medicare drug plans payPart D · Q2 2026 $452.01 $37,969.14 / 84 capsules
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
82448-0260-42 82448-260-42 Main listing 42 CAPSULE in 1 BOTTLE 2025-02-11 — Active
82448-0260-84 You're viewing this 84 CAPSULE in 1 BOTTLE 2025-02-11 — Active

You're viewing the largest of 2 pack sizes for this product.

This pack accounts for about 41% of this product's recent Medicaid fills; most go to the 42 capsules pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 84-count package — 84 capsule in 1 bottle.
How does this package differ from NDC 82448-0260-42?
Both are Gomekli mirdametinib 2 mg Capsule — the drug itself is identical. This page's package is the 84-count one, while NDC 82448-0260-42 is the 42 capsules package.
What NDC number is used to bill for this package of Gomekli mirdametinib 2 mg Capsule?
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
Gomekli 2 mgthis 82448-0260-84 SpringWorks 84 capsules — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2025
First FDA approval
Feb 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2044
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2044. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 11, 2025 RLD RS ⏳ ~18 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 11883375 — method of use (U-4130)
US 11883375 — method of use (U-4130)
US 11839595 — method of use (U-4130)
US 11839595 — method of use (U-4130)
US 11806322 — method of use (U-4130)
US 11806322 — method of use (U-4130)
US 11806321 — method of use (U-4130)
US 11806321 — method of use (U-4130)
US 11453641 — method of use (U-4130)
US 11453641 — method of use (U-4130)
US 12263146 — method of use (U-4130)
US 12263146 — method of use (U-4130)
US 12257215 — method of use (U-4130)
US 12257215 — method of use (U-4130)
US 12275688 — method of use (U-4130)
US 12275688 — method of use (U-4130)
US 12390430 — method of use (U-4130)
US 12390430 — method of use (U-4130)
US 12383517 — method of use (U-4130)
US 12383517 — method of use (U-4130)
US 12220390 — method of use (U-4130)
US 12220390 — method of use (U-4130)
US 12037306 — method of use (U-4130)
US 12037306 — method of use (U-4130)
US 12029711 — method of use (U-4130)
US 12029711 — method of use (U-4130)
US 12324791 — method of use (U-4591)
US 12324791 — method of use (U-4591)
US 12295925 — method of use (U-4590)
US 12295925 — method of use (U-4590)
US 12011424 — method of use (U-4595)
US 11819487 — method of use (U-4590)
US 11819487 — method of use (U-4590)
US 12661330 — method of use (U-4130)
US 12661330 — method of use (U-4130)
US 11084780 — drug substance
US 11066358 — drug substance
US 11066358 — drug substance
US 11084780 — drug substance
Exclusivity NCE
Exclusivity ODE-488
Exclusivity NCE
Exclusivity ODE-488
2025 2027 2029 2031 2033 2035 2037 2039 2041 2043
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 (39)
PatentTypeUse codeExpires
US 11883375 ↗ Method of use U-4130 Mar 16, 2043
US 11883375 ↗ Method of use U-4130 Mar 16, 2043
US 11839595 ↗ Method of use U-4130 Mar 16, 2043
US 11839595 ↗ Method of use U-4130 Mar 16, 2043
US 11806322 ↗ Method of use U-4130 Apr 9, 2043
US 11806322 ↗ Method of use U-4130 Apr 9, 2043
US 11806321 ↗ Method of use U-4130 Feb 17, 2041
US 11806321 ↗ Method of use U-4130 Feb 17, 2041
US 11453641 ↗ Method of use U-4130 Feb 17, 2041
US 11453641 ↗ Method of use U-4130 Feb 17, 2041
US 12263146 ↗ Method of use U-4130 Feb 17, 2041
US 12263146 ↗ Method of use U-4130 Feb 17, 2041
US 12257215 ↗ Method of use U-4130 Mar 16, 2043
US 12257215 ↗ Method of use U-4130 Mar 16, 2043
US 12275688 ↗ Method of use U-4130 Feb 17, 2041
US 12275688 ↗ Method of use U-4130 Feb 17, 2041
US 12390430 ↗ Method of use U-4130 Oct 10, 2044
US 12390430 ↗ Method of use U-4130 Oct 10, 2044
US 12383517 ↗ Method of use U-4130 Mar 15, 2044
US 12383517 ↗ Method of use U-4130 Mar 15, 2044
US 12220390 ↗ Method of use U-4130 Mar 16, 2043
US 12220390 ↗ Method of use U-4130 Mar 16, 2043
US 12037306 ↗ Method of use U-4130 Feb 17, 2041
US 12037306 ↗ Method of use U-4130 Feb 17, 2041
US 12029711 ↗ Method of use U-4130 Mar 15, 2044
US 12029711 ↗ Method of use U-4130 Mar 15, 2044
US 12324791 ↗ Method of use U-4591 Mar 16, 2043
US 12324791 ↗ Method of use U-4591 Mar 16, 2043
US 12295925 ↗ Method of use U-4590 Feb 17, 2041
US 12295925 ↗ Method of use U-4590 Feb 17, 2041
US 12011424 ↗ Method of use U-4595 Feb 17, 2041
US 11819487 ↗ Method of use U-4590 Feb 17, 2041
US 11819487 ↗ Method of use U-4590 Feb 17, 2041
US 12661330 ↗ Method of use U-4130 Feb 5, 2044
US 12661330 ↗ Method of use U-4130 Feb 5, 2044
US 11084780 ↗ Drug substance — Feb 17, 2041
US 11066358 ↗ Drug substance — Feb 17, 2041
US 11066358 ↗ Drug substance — Feb 17, 2041
US 11084780 ↗ Drug substance — Feb 17, 2041
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Feb 11, 2030
ODE-488Orphan Drug Exclusivity (7-year)Feb 11, 2032
NCENew Chemical Entity (5-year)Feb 11, 2030
ODE-488Orphan Drug Exclusivity (7-year)Feb 11, 2032
Common questions
Is there a generic version of GOMEKLI 2 MG CAPSULE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for GOMEKLI 2 MG CAPSULE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2044 — an estimate, not a guaranteed launch date.
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.

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

LabelerSpringWorks Therapeutics, Inc.
Application holderSPRINGWORKS THERAPEUTICS INC
FDA applicationNDA219389 (NDA)
Labeler code82448
First marketedFeb 2025
Product typeHuman Prescription Drug
Portfolio5 products on file

More NDCs from SpringWorks Therapeutics, Inc. labeler code 82448

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 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
102
Units reimbursed last 4 qtrs
8.6K
Gross reimbursed last 4 qtrs
$3.67M
Avg / prescription
$35,942.36
Avg / unit
$425.80
Latest quarter Q1 2026
58Rx
Fee-for-service vs managed care ⓘ
48% FFS 52% MCO
Fee-for-service · 49 Rx Managed care · 53 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: no data reported MI New York: 2,730 units · 13.9 per 100k residents 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: 1,428 units · 3.7 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: 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: 4,452 units · 14.6 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.714.6
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Texas 14.6 /100k
2 New York 13.9 /100k
3 California 3.7 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
42 capsules82448-0260-42 149 Rx · $3,270,716
84 capsules this page82448-0260-84 102 Rx · $3,666,121
Drug total (last 4 qtrs): 251 Rx · 16,509 units · $6,936,837 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Gomekli — 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 Gomekli. 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
$6.34M
Claims incl. refills
247
Beneficiaries
88
Spend / beneficiary
$72,094.78
Spend / claim
$25,685.59
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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ 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 SpringWorks Therapeutics, Inc.. 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 42 capsules (82448-0260-42). 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?
SpringWorks Therapeutics, 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.
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.
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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.