Mixed Salts of a Single-Entity Amphetamine Product

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate · DEXTROAMPHETAMINE SULFATE 3.125 mg/1; DEXTROAMPHETAMINE SACCHARATE 3.125 mg/1; AMPHETAMINE ASPARTATE MONOHYDRATE 3.125 mg/1; AMPHETAMINE SULFATE 3.125 mg/1 · Capsule, Extended Release · Oral · SpecGx LLC

NDC 00406-0805-01 · 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

4 companies list this market — a reasonable cushion if one runs into trouble.

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

$975.81

Reported to Texas DSHS · 2026 annual filing · SpecGX LLC · package: 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

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

Supply fragility

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

90-day shortage risk (model v2)

0.2%chance of a new FDA shortage posting for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months)

For scale: the typical drug’s chance is about 0.1% — this one is less than 1.5× that, which we treat as ordinary.

Backtested statistical model over the whole market, not this package alone. Model details →

ⓘ How this was built

Data sources

FDA NDC Directory labeler counts, CMS NADAC price trend, openFDA shortages and enforcement, FDA inspection classifications, Wayback archive of FDA's shortage list (labels)

Method

A logistic regression over molecule × dosage-form markets, trained on a monthly grid of historical dates since 2019 with labels equal to whether a new FDA shortage posting appeared within the following 90 days; eight features knowable on each date (labeler count, sole-source flag, NADAC year-over-year change, Class I/II recalls, injectable form, discontinuation filings, open shortage episodes, recent OAI inspection). The probability shown is the model's output for today's feature values; the reasons are the features pushing this market's probability up, listed only when the feature actually holds here. Held-out performance and coefficients are on the fragility page.

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

Where it's made

SpecGx LLCUnited States
api manufacture
SpecGx LLCUnited States
analysis · manufacture

Establishments this product's FDA label declares, with the role the label gives each (manufacture, API manufacture, pack, label, repack, analysis), located via FDA registration data. How we built this →

ⓘ How this was built

Data sources

DailyMed SPL labels (human prescription full release, monthly) — establishment DUNS and operations per label
FDA Drug Establishments Current Registration Site (DECRS) — DUNS to name and country
FDA Data Dashboard inspection classifications (Drug Quality Assurance)

Method

The label for this product's NDC-9 names each establishment and its operations; those DUNS numbers are matched to FDA's registration list for name and country. Only rows with a MANUFACTURE or API MANUFACTURE operation are places the drug is made; repack, relabel, pack, label and analysis rows are shown as what they are. The OAI badge means a drug-quality (GMP) inspection at that facility ended in Official Action Indicated within 24 months. Labels list plants, not volumes — a drug with two named plants may be made almost entirely at one. To check: open the label on DailyMed and its establishment section.

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

Regulatory

Application: ANDA211546
TE code: AB2
Approval date: Aug 31, 2023
Patents / exclusivity: None on file

ⓘ How this was built

Data sources

FDA Orange Book data files — patent and exclusivity tables for application ANDA211546, 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.

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.

Not on FDA's current shortage list. Archived episodes below.

Archived episodes (FDA list history via Wayback, 2019+)

In shortage now — Elite Laboratories, Inc., Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 64850-506-01) (listed as “Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet”)Aug 15, 2023 → last seen Jul 20, 2026
In shortage now — Teva Pharmaceuticals USA, Inc., Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 0555-0971-02) (listed as “Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet”)Oct 12, 2022 → last seen Jul 20, 2026
In shortage now — Teva Pharmaceuticals USA, Inc., Adderall, Tablet, 5 mg; 5 mg; 5 mg; 5 mg (NDC 57844-120-01) (listed as “Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet”)Oct 12, 2022 → last seen Jul 20, 2026
In shortage now — Teva Pharmaceuticals USA, Inc., Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 0555-0972-02) (listed as “Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet”)Oct 12, 2022 → last seen Jul 20, 2026
In shortage now — Teva Pharmaceuticals USA, Inc., Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 0555-0974-02) (listed as “Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet”)Oct 12, 2022 → last seen Jul 20, 2026
In shortage now — Sandoz Inc., Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 5 mg; 5 mg; 5 mg; 5 mg (NDC 0185-0853-01) (listed as “Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet”)Oct 12, 2022 → last seen Jul 20, 2026
In shortage now — Oryza Pharmaceuticals Inc., Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 72516-014-01) (listed as “Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet”)Oct 12, 2022 → last seen Jul 20, 2026
In shortage now — Oryza Pharmaceuticals Inc., Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 72516-016-01) (listed as “Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet”)Oct 12, 2022 → last seen Jul 20, 2026

Showing 8 of 30 archived episodes.

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.

No enforcement reports list this package NDC.

Labelers of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate (Capsule, Extended Release)

4 labelers 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
SpecGx LLC	AMPHETAMINE ASPARTATE MONOHYDRATE 6.25 mg/1; AMPHETAMINE SULFATE 6.25 mg/1; DEXTROAMPHETAMINE SACCHARATE 6.25 mg/1; DEXTROAMPHETAMINE SULFATE 6.25 mg/1; AMPHETAMINE ASPARTATE MONOHYDRATE 1.25 mg/1; AMPHETAMINE SULFATE 1.25 mg/1; DEXTROAMPHETAMINE SACCHARATE 1.25 mg/1; DEXTROAMPHETAMINE SULFATE 1.25 mg/1; AMPHETAMINE ASPARTATE MONOHYDRATE 12.5 mg/1; AMPHETAMINE SULFATE 12.5 mg/1; DEXTROAMPHETAMINE SACCHARATE 12.5 mg/1; DEXTROAMPHETAMINE SULFATE 12.5 mg/1 (+6 more)	Jul 15, 2026	Sep 3, 2026
Actavis Pharma, Inc.	AMPHETAMINE ASPARTATE MONOHYDRATE 1.25 mg/1; AMPHETAMINE SULFATE 1.25 mg/1; DEXTROAMPHETAMINE SACCHARATE 1.25 mg/1; DEXTROAMPHETAMINE SULFATE 1.25 mg/1; AMPHETAMINE ASPARTATE MONOHYDRATE 2.5 mg/1; AMPHETAMINE SULFATE 2.5 mg/1; DEXTROAMPHETAMINE SACCHARATE 2.5 mg/1; DEXTROAMPHETAMINE SULFATE 2.5 mg/1; AMPHETAMINE ASPARTATE MONOHYDRATE 3.75 mg/1; AMPHETAMINE SULFATE 3.75 mg/1; DEXTROAMPHETAMINE SACCHARATE 3.75 mg/1; DEXTROAMPHETAMINE SULFATE 3.75 mg/1 (+3 more)	Jul 15, 2026	Sep 2, 2026
Catalent Pharma Solutions, LLC	AMPHETAMINE ASPARTATE MONOHYDRATE 12.5 mg/1; AMPHETAMINE SULFATE 12.5 mg/1; DEXTROAMPHETAMINE SACCHARATE 12.5 mg/1; DEXTROAMPHETAMINE SULFATE 12.5 mg/1; AMPHETAMINE ASPARTATE MONOHYDRATE 6.25 mg/1; AMPHETAMINE SULFATE 6.25 mg/1; DEXTROAMPHETAMINE SACCHARATE 6.25 mg/1; DEXTROAMPHETAMINE SULFATE 6.25 mg/1; AMPHETAMINE ASPARTATE MONOHYDRATE 9.375 mg/1; AMPHETAMINE SULFATE 9.375 mg/1; DEXTROAMPHETAMINE SACCHARATE 9.375 mg/1; DEXTROAMPHETAMINE SULFATE 9.375 mg/1	Jul 15, 2026	Sep 2, 2026
Sun Pharmaceutical Industries, Inc.	AMPHETAMINE ASPARTATE MONOHYDRATE 12.5 mg/1; AMPHETAMINE SULFATE 12.5 mg/1; DEXTROAMPHETAMINE SACCHARATE 12.5 mg/1; DEXTROAMPHETAMINE SULFATE 12.5 mg/1; AMPHETAMINE ASPARTATE MONOHYDRATE 3.125 mg/1; AMPHETAMINE SULFATE 3.125 mg/1; DEXTROAMPHETAMINE SACCHARATE 3.125 mg/1; DEXTROAMPHETAMINE SULFATE 3.125 mg/1; AMPHETAMINE ASPARTATE MONOHYDRATE 6.25 mg/1; AMPHETAMINE SULFATE 6.25 mg/1; DEXTROAMPHETAMINE SACCHARATE 6.25 mg/1; DEXTROAMPHETAMINE SULFATE 6.25 mg/1 (+1 more)	Jul 15, 2026	Sep 2, 2026

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

Cite this page

DrugDashboards, "Mixed Salts of a Single-Entity Amphetamine Product — NDC 00406-0805-01," retrieved September 4, 2026, https://drugdashboards.com/drug/00406080501.

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