DrugDashboards

Buprenorphine and Naloxone

Buprenorphine and Naloxone · BUPRENORPHINE HYDROCHLORIDE 4 mg/1; NALOXONE 1 mg/1 · Film, Soluble · Buccal; Sublingual · Dr.Reddys Laboratories Inc

NDC 43598-0580-30 · 30 POUCH in 1 CARTON / 1 FILM, SOLUBLE in 1 POUCH · ANDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. The price is down 26% over the past year, to $2.53 per unit. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

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)$2.53per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Federal contracts pay (FSS)$2.12per unitGolden State Medical Supply, Inc. · Dec 15, 202584% of what pharmacies pay — a deeper discount than 57% of drugs with this benchmark

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

$0$2.00$4.00$6.00May 2019Sep 2026$2.53
89 price points · per EASource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$119.64
Reported to Texas DSHS · 2026 annual filing · Dr. Reddy's Laboratories, Inc.

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

Medicaid spend (2025)

$4.8M
45,765 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

28Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 2 active manufacturers+20
  • price down 29% year over year+8

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 (other) 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 · Brixadi

Regulatory

Application
ANDA205806
TE code
AB
Approval date
Jun 14, 2018
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 (Film, Soluble)

LabelerStrengthFirst seenLast seen
Camber Pharmaceuticals, Inc.BUPRENORPHINE HYDROCHLORIDE 12 mg/1; NALOXONE HYDROCHLORIDE 3 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.BUPRENORPHINE HYDROCHLORIDE 4 mg/1; NALOXONE HYDROCHLORIDE 1 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.BUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE HYDROCHLORIDE .5 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.BUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE HYDROCHLORIDE 2 mg/1Jul 15, 2026Sep 2, 2026
Dr.Reddys Laboratories IncBUPRENORPHINE HYDROCHLORIDE 4 mg/1; NALOXONE 1 mg/1Jul 15, 2026Sep 2, 2026
Dr.Reddys Laboratories IncBUPRENORPHINE HYDROCHLORIDE 2 mg/1; NALOXONE .5 mg/1Jul 15, 2026Sep 2, 2026
Dr.Reddys Laboratories IncBUPRENORPHINE HYDROCHLORIDE 12 mg/1; NALOXONE 3 mg/1Jul 15, 2026Sep 2, 2026
Dr.Reddys Laboratories IncBUPRENORPHINE HYDROCHLORIDE 8 mg/1; NALOXONE 2 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Buprenorphine and Naloxone — NDC 43598-0580-30," retrieved September 3, 2026, https://drugdashboards.com/drug/43598058030.

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