DrugDashboards

Tapentadol Hydrochloride

Tapentadol Hydrochloride · TAPENTADOL HYDROCHLORIDE 75 mg/1 · Tablet, Film Coated · Oral · Epic Pharma Llc

NDC 42806-0627-01 · 100 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 24510-0075-10) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

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

Plans pay at point of sale
$14.57per unit
middle half $14.45$14.64 · 12 plans · Apr 1, 2026
Est. net of rebates
≈ $14.57
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 5 · prior auth 100% · step therapy 0% · qty limit 100%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

NADAC price per unit

$0$5.00$10.00$15.00May 2026Sep 2026$10.73
4 price points · per EASource: CMS NADAC

Estimated fill cost

#30 count
$321.81
#90 count
$965.42

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Supply fragility

10Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • 3 active manufacturers+10

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for tapentadol hydrochloride (oral solid) in the next 90 days

sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

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

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

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 · Opioid Analgesic REMS Shared System REMS

Regulatory

Application
ANDA214378
TE code
AB
Approval date
Jan 27, 2026
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Tapentadol Hydrochloride (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Collegium Pharmaceutical, Inc.TAPENTADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Collegium Pharmaceutical, Inc.TAPENTADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Collegium Pharmaceutical, Inc.TAPENTADOL HYDROCHLORIDE 75 mg/1Jul 15, 2026Sep 2, 2026
Epic Pharma LlcTAPENTADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Epic Pharma LlcTAPENTADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Epic Pharma LlcTAPENTADOL HYDROCHLORIDE 75 mg/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.TAPENTADOL HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.TAPENTADOL HYDROCHLORIDE 75 mg/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.TAPENTADOL HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Tapentadol Hydrochloride — NDC 42806-0627-01," retrieved September 3, 2026, https://drugdashboards.com/drug/42806062701.

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