DrugDashboards

buprenorphine and naloxone

buprenorphine and naloxone · BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1 · Tablet · Sublingual · Hikma Pharmaceuticals USA Inc.

NDC 00054-0188-13 · 30 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

14 companies supply this market — deep enough that no single failure threatens the supply. The price is down 15% over the past year, to $0.4620 per unit. 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.

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.

  • Pharmacies pay (NADAC)$0.4620per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D point of sale (median)$0.6805per unitnegotiated price across 5,489 plans — before rebates · Apr 1, 2026
  • Federal contracts pay (FSS)$0.9227per unitGolden State Medical Supply, Inc. · Jun 15, 2023200% of what pharmacies pay — higher than 76% of drugs with this benchmark
  • Medicaid generic ceiling (FUL)$0.4620per TABweighted avg manufacturer price $0.2310 · Aug 1, 2026100% of what pharmacies pay — higher than 10% of drugs with this benchmark

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
$0.6805per unit
middle half $0.4279$1.26 · 5,489 plans · Apr 1, 2026
Est. net of rebates
≈ $0.6805
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 2 · prior auth 0% · step therapy 0% · qty limit 40%

*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$2.00$4.00Aug 2014Sep 2026$0.462
146 price points · per EA · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$13.86
#90 count
$41.58

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

Medicaid spend (2025)

$7.1M
144,234 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

0Low risk

Nothing here is signaling trouble: several manufacturers, no current shortage, no recent serious recalls, stable pricing. In drug supply, boring is the good outcome.

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 buprenorphine and naloxone (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 · median tier 2 across plans
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Brixadi

Regulatory

Application
ANDA203326
TE code
AB
Approval date
Jun 27, 2014
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 buprenorphine and naloxone (Tablet)

LabelerStrengthFirst seenLast seen
Bryant Ranch PrepackBUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1Jul 15, 2026Sep 3, 2026
Actavis Pharma, Inc.BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1Jul 15, 2026Sep 2, 2026
Actavis Pharma, Inc.BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingBUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingBUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCBUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCBUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCBUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE 2 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCBUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE .5 mg/1Jul 15, 2026Sep 2, 2026
AvPAKBUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1Jul 15, 2026Sep 2, 2026
AvPAKBUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackBUPRENORPHINE 8 mg/1; NALOXONE 2 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackBUPRENORPHINE 2 mg/1; NALOXONE .5 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1Aug 5, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1Aug 5, 2026Sep 2, 2026
Lannett Company, Inc.BUPRENORPHINE 8 mg/1; NALOXONE 2 mg/1Jul 15, 2026Sep 2, 2026
Lannett Company, Inc.BUPRENORPHINE 2 mg/1; NALOXONE .5 mg/1Jul 15, 2026Sep 2, 2026
Redpharm DrugBUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1Jul 15, 2026Sep 2, 2026
Rhodes Pharmaceuticals LLCBUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Rhodes Pharmaceuticals LLCBUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1Jul 15, 2026Sep 2, 2026
Unit Dose Solutions, Inc.BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackBUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1Jul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "buprenorphine and naloxone — NDC 00054-0188-13," retrieved September 3, 2026, https://drugdashboards.com/drug/00054018813.

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