Netspot

68Ga-DOTATATE · Kit · Intravenous · Advanced Accelerator Applications USA, Inc

NDC 69488-0001-40 · 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE · NDA · View full market →

The short version

Only one company currently lists this market in the FDA directory — there is no backup if it stumbles.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

ⓘ How this was built

Data sources

FDA NDC Directory (openFDA) — labelers active in the last 30 days, repackagers classified from DailyMed SPL establishment roles
CMS NADAC — latest price vs the price in effect ~12 months earlier
FDA drug shortages and enforcement reports (openFDA)
FDA inspection classifications; DrugDashboards fragility score and 90-day shortage model

Method

Each sentence is a template that fires only when its condition holds in the data shown lower on this page: maker counts are distinct FDA labelers listing this molecule and dosage form in the last 30 days minus classified repackagers; the price trend compares the newest NADAC with the last price in effect at least 9 months earlier; shortage and recall sentences restate FDA rows for this drug's presentations (Class I/II, trailing 12 months); the plant sentence needs a MANUFACTURE-role establishment with a drug-quality OAI in 24 months; the verdict restates the fragility band; the risk sentence appears only when the model's probability is at least 1.5× the typical market. Nothing here is inferred beyond those rules.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

ⓘ How this was built

Data sources

CMS NADAC weekly files (data.medicaid.gov), December 2024 onward
CMS NADAC per-year archive files, 2013 – November 2024, averaged per month
CMS Federal Upper Limit file — weighted average manufacturer price (WAMP) of the generic group (dashed line)

Method

One line, two regimes: before December 2024 each point is the average of that month's archived NADAC rows for this NDC; from December 2024 each point is a row from the weekly file, which CMS publishes only when the price changes, so the line holds flat until the next change and is extended to today when the last row is under 6 months old. Since the December 2024 file CMS computes generic NADAC as a 3-month moving average, so recent generic moves are smoothed and lag the market. The dashed WAMP is the manufacturer-side average for the whole multiple-source group, not this NDC alone. To check a point: open the NADAC file for that date on data.medicaid.gov and find this NDC.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Estimated fill cost

WAC per package, as filed

$3,120.00

Reported to Texas DSHS · 2026 annual filing · Novartis Pharmaceuticals Corporation · package: 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicaid spend (2025)

ⓘ How this was built

Data sources

CMS State Drug Utilization Data (SDUD), data.medicaid.gov

Method

CMS's Medicaid Amount Reimbursed for this exact NDC over the period shown, fee-for-service and managed care together — the program's gross payment to pharmacies before manufacturer rebates (statutory rebates alone recover 23.1% or more of a brand's price). Taken from CMS's own national row for the NDC (state code XX), which still counts the state-level cells CMS blanks for privacy (fewer than 11 prescriptions in a state-quarter); a quarter with fewer than 11 prescriptions nationally is blanked even there. The prescription count is CMS's Number of Prescriptions. To check: filter the SDUD file for the year to this NDC and State = XX and sum the column.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

$1.7M

746 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

Not scored — fragility is computed for NDCs that have a NADAC price and a generic name.

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

Part D specialty tier
Costs ≥ $950/fill
Biologic (BLA)
Injectable / infused
Orphan-drug exclusivity
REMS program

Regulatory

Application: NDA208547
TE code: —
Approval date: Jun 1, 2016
Patents / exclusivity: 1 patent (1 unexpired), 0 exclusivity codes (0 unexpired)

ⓘ How this was built

Data sources

FDA Orange Book data files — patent and exclusivity tables for application NDA208547, edition retrieved 2026-08-24

Method

Rows are the Orange Book's patent and exclusivity listings for this NDA, de-duplicated across product numbers (the file repeats a listing for every strength). A listed patent is a claim the sponsor filed; it may cover a use rather than the molecule, may be challenged, and may be delisted — a listing is not proof a generic is blocked. Pediatric extensions appear as *PED rows. FDA blocks automated downloads of the Orange Book from cloud servers, so the edition can trail FDA's monthly release; the retrieval date above is the edition shown. To check: search the application number on FDA's Orange Book site.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Type	Number / code	Expires
patent	9375498	Aug 10, 2032

Shortage history

ⓘ How this was built

Data sources

FDA drug shortages via openFDA (current file: Current, To Be Discontinued, and recently Resolved rows)
Internet Archive (Wayback) snapshots of FDA's shortage list since 2019, reconstructed into episodes
DrugDashboards Kaplan–Meier duration curves and conditional duration model

Method

Top rows are FDA's live listings whose package NDC is this product or another package of the same generic name and dosage form. openFDA drops resolved rows after about six months, so older episodes come from monthly Wayback snapshots of FDA's file, matched on the molecule with dosage-form words stripped (that matching can pull in other salts or forms of the same molecule — the presentation is shown so you can tell). 'Month N of a typical M' compares this episode's age with the Kaplan–Meier median for its form class (injectable, oral solid, other) over episodes since October 2019, open episodes censored; the resolution odds come from a model conditioned on the episode's age and reason. To check: FDA's drug shortage database, and web.archive.org for its history.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

No FDA shortage listing for this drug's presentations in the current file, and no archived episode since 2019.

Recalls (this NDC)

ⓘ How this was built

Data sources

FDA drug enforcement reports via openFDA

Method

Enforcement reports whose product NDC list includes this exact package NDC, newest first, with FDA's classification (I = reasonable probability of serious harm, II = temporary or reversible harm, III = unlikely to cause harm) and the recall's current status. Reports for other packages of the same drug are not shown here; 275 of the last year's Class I/II reports carry no NDC at all and cannot be matched. To check: search the recall number on openFDA or FDA's enforcement reports.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Class III · TerminatedMar 18, 2022
Advanced Accelerator Applications USA, Inc. — Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Class II · TerminatedJan 10, 2020
Advanced Accelerator Applications USA, Inc. — Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).

Labelers of 68Ga-DOTATATE (Kit)

1 labeler active in the last 30 days; 0not seen for 30+ days. Keyed on FDA's generic-name string — other salts or forms of the molecule are separate rosters.

ⓘ How this was built

Data sources

FDA NDC Directory (openFDA), read daily since 2026-07-15 — labeler_name per package
DailyMed SPL establishment roles + name patterns → derived.labeler_kinds (repackager / manufacturer / unknown)

Method

One row per labeler that lists any package with this exact generic-name string and dosage form; strengths are combined. 'First seen' is the first daily snapshot that contained the labeler here (2026-07-15 for everything present at the start), 'last seen' the most recent; a labeler counts as active when seen in the last 30 days. Repackagers and relabelers are flagged when their own labels show only repack/relabel operations or their name matches a known repackager, and are excluded from every 'makers' count on this page. Listing is not volume: a labeler with a listed NDC may ship little or nothing. To check: search the generic name in FDA's NDC Directory and list the labelers.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Labeler	Strengths	First seen	Last seen
Advanced Accelerator Applications USA, Inc		Jul 15, 2026	Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 15, 2026.

Cite this page

DrugDashboards, "Netspot — NDC 69488-0001-40," retrieved September 4, 2026, https://drugdashboards.com/drug/69488000140.

Free to cite with attribution — see how the data is put together.