DrugDashboards

Oxycodone Hydrochloride and Acetaminophen

Oxycodone Hydrochloride and Acetaminophen · OXYCODONE HYDROCHLORIDE 7.5 mg/1; ACETAMINOPHEN 325 mg/1 · Tablet · Oral · Elite Laboratories, Inc.

NDC 64850-0622-01 · 100 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble. The price is down 13% over the past year, to $0.1825 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.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 63481-0628-70) — 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ⓘ
$0.1922per unit
middle half $0.1922–$0.2305 · 9 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $0.1922
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 2 · prior auth 0% · 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 8 quarters since 2024.

NADAC price per unit

$0$0.1$0.2$0.3Jul 2025Sep 2026$0.1825
15 price points · per EASource: CMS NADAC

Estimated fill cost

#30 count
$5.47
#90 count
$16.42

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

Medicaid spend (2025)

$899
45 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

13● Low risk

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

  • 4 active manufacturers+5
  • Class I/II recall on same molecule/form in past 12 months+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)

0.2%chance of a new FDA shortage posting for oxycodone hydrochloride and acetaminophen (oral solid) in the next 90 days

sole-source market · 2 Class I/II recall(s) in 12 months

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
ANDA209385
TE code
AA
Approval date
Jul 2, 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 Oxycodone Hydrochloride and Acetaminophen (Tablet)

LabelerStrengthFirst seenLast seen
Elite Laboratories, Inc.OXYCODONE HYDROCHLORIDE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Elite Laboratories, Inc.OXYCODONE HYDROCHLORIDE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Elite Laboratories, Inc.OXYCODONE HYDROCHLORIDE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
St. Mary's Medical Park PharmacyOXYCODONE HYDROCHLORIDE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
St. Mary's Medical Park PharmacyOXYCODONE HYDROCHLORIDE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
St. Mary's Medical Park PharmacyOXYCODONE HYDROCHLORIDE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
SpecGx LLCOXYCODONE HYDROCHLORIDE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Aug 31, 2026
SpecGx LLCOXYCODONE HYDROCHLORIDE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Aug 31, 2026
SpecGx LLCOXYCODONE HYDROCHLORIDE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Aug 28, 2026
SpecGx LLCOXYCODONE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 5 mg/1Jul 22, 2026Aug 22, 2026
SpecGx LLCOXYCODONE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 10 mg/1Jul 22, 2026Aug 21, 2026
SpecGx LLCOXYCODONE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 7.5 mg/1Jul 22, 2026Aug 21, 2026
Elite Laboratories, Inc.OXYCODONE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 5 mg/1Jul 22, 2026Aug 19, 2026
Elite Laboratories, Inc.OXYCODONE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 7.5 mg/1Jul 22, 2026Aug 19, 2026
Elite Laboratories, Inc.OXYCODONE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 10 mg/1Jul 22, 2026Aug 19, 2026
St. Mary's Medical Park PharmacyOXYCODONE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 5 mg/1Jul 22, 2026Aug 19, 2026
St. Mary's Medical Park PharmacyOXYCODONE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 7.5 mg/1Jul 22, 2026Aug 19, 2026
St. Mary's Medical Park PharmacyOXYCODONE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 10 mg/1Jul 22, 2026Aug 19, 2026
Endo USA, Inc.OXYCODONE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 10 mg/1Jul 22, 2026Aug 12, 2026
Endo USA, Inc.OXYCODONE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 5 mg/1Jul 22, 2026Aug 12, 2026
Endo USA, Inc.OXYCODONE HYDROCHLORIDE 325 mg/1; ACETAMINOPHEN 7.5 mg/1Jul 22, 2026Aug 12, 2026
St. Mary's Medical Park PharmacyACETAMINOPHEN 325 mg/1; OXYCODONE HYDROCHLORIDE 10 mg/1Jul 15, 2026Jul 18, 2026
Elite Laboratories, Inc.ACETAMINOPHEN 325 mg/1; OXYCODONE HYDROCHLORIDE 7.5 mg/1Jul 15, 2026Jul 15, 2026
Elite Laboratories, Inc.ACETAMINOPHEN 325 mg/1; OXYCODONE HYDROCHLORIDE 10 mg/1Jul 15, 2026Jul 15, 2026
Elite Laboratories, Inc.ACETAMINOPHEN 325 mg/1; OXYCODONE HYDROCHLORIDE 5 mg/1Jul 15, 2026Jul 15, 2026
Endo USA, Inc.ACETAMINOPHEN 325 mg/1; OXYCODONE HYDROCHLORIDE 10 mg/1Jul 15, 2026Jul 15, 2026
Endo USA, Inc.ACETAMINOPHEN 325 mg/1; OXYCODONE HYDROCHLORIDE 5 mg/1Jul 15, 2026Jul 15, 2026
Endo USA, Inc.ACETAMINOPHEN 325 mg/1; OXYCODONE HYDROCHLORIDE 7.5 mg/1Jul 15, 2026Jul 15, 2026
SpecGx LLCACETAMINOPHEN 325 mg/1; OXYCODONE HYDROCHLORIDE 10 mg/1Jul 15, 2026Jul 15, 2026
SpecGx LLCACETAMINOPHEN 325 mg/1; OXYCODONE HYDROCHLORIDE 7.5 mg/1Jul 15, 2026Jul 15, 2026
SpecGx LLCACETAMINOPHEN 325 mg/1; OXYCODONE HYDROCHLORIDE 5 mg/1Jul 15, 2026Jul 15, 2026
St. Mary's Medical Park PharmacyACETAMINOPHEN 325 mg/1; OXYCODONE HYDROCHLORIDE 5 mg/1Jul 15, 2026Jul 15, 2026
St. Mary's Medical Park PharmacyACETAMINOPHEN 325 mg/1; OXYCODONE HYDROCHLORIDE 7.5 mg/1Jul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Oxycodone Hydrochloride and Acetaminophen — NDC 64850-0622-01," retrieved September 3, 2026, https://drugdashboards.com/drug/64850062201.

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