DrugDashboards

Hydrocodone Bitartrate

Hydrocodone Bitartrate · HYDROCODONE BITARTRATE 40 mg/1 · Tablet, Extended Release · Oral · Alvogen Inc.

NDC 47781-0394-60 · 60 TABLET, EXTENDED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately.

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

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

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

  • Part D plans paid (avg)$9.23per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$12.64per unitnegotiated price across 1,329 plans — before rebates · Apr 1, 2026

Medicare Part D

All Part D pricing →
ⓘ 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
$12.64per unit
middle half $9.02$15.03 · 1,329 plans · Apr 1, 2026
Est. net of rebates
≈ $12.64
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
24%of plans cover it
tier 4 · prior auth 98% · step therapy 1% · qty limit 99%

*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

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

Estimated fill cost

WAC per package, as filed
$921.53
Reported to Texas DSHS · 2026 annual filing · Alvogen Inc.

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

Medicaid spend (2022)

$15,406
36 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

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

sole-source market · price up 9% YoY

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 →

Is this a "specialty" drug?

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

  • Part D specialty tier · median tier 4 across plans
  • Costs ≥ $950/fill · avg $557.50 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Opioid Analgesic REMS Shared System REMS

Regulatory

Application
ANDA208269
TE code
AB
Approval date
Mar 1, 2021
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 Hydrocodone Bitartrate (Tablet, Extended Release)

LabelerStrengthFirst seenLast seen
Alvogen Inc.HYDROCODONE BITARTRATE 40 mg/1Jul 15, 2026Sep 2, 2026
Alvogen Inc.HYDROCODONE BITARTRATE 120 mg/1Jul 15, 2026Sep 2, 2026
Alvogen Inc.HYDROCODONE BITARTRATE 60 mg/1Jul 15, 2026Sep 2, 2026
Alvogen Inc.HYDROCODONE BITARTRATE 30 mg/1Jul 15, 2026Sep 2, 2026
Alvogen Inc.HYDROCODONE BITARTRATE 80 mg/1Jul 15, 2026Sep 2, 2026
Alvogen Inc.HYDROCODONE BITARTRATE 100 mg/1Jul 15, 2026Sep 2, 2026
Alvogen Inc.HYDROCODONE BITARTRATE 20 mg/1Jul 15, 2026Sep 2, 2026
Knoa Pharma LLCHYDROCODONE BITARTRATE 80 mg/1Jul 15, 2026Sep 2, 2026
Knoa Pharma LLCHYDROCODONE BITARTRATE 100 mg/1Jul 15, 2026Sep 2, 2026
Knoa Pharma LLCHYDROCODONE BITARTRATE 20 mg/1Jul 15, 2026Sep 2, 2026
Knoa Pharma LLCHYDROCODONE BITARTRATE 30 mg/1Jul 15, 2026Sep 2, 2026
Knoa Pharma LLCHYDROCODONE BITARTRATE 40 mg/1Jul 15, 2026Sep 2, 2026
Knoa Pharma LLCHYDROCODONE BITARTRATE 60 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Hydrocodone Bitartrate — NDC 47781-0394-60," retrieved September 3, 2026, https://drugdashboards.com/drug/47781039460.

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