DrugDashboards

Hydrocodone Bitartrate and Acetaminophen

Hydrocodone Bitartrate and Acetaminophen · HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1 · Tablet · Oral · Lupin Pharmaceuticals,Inc.

NDC 43386-0357-01 · 100 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

15 companies supply this market — deep enough that no single failure threatens the supply. The price is down 11% over the past year, to $0.1389 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)$0.1389per EAinvoice-surveyed acquisition cost · Jun 17, 2026
  • Medicaid generic ceiling (FUL)$0.1389per TABweighted avg manufacturer price $0.0654 · Jun 1, 2026100% of what pharmacies pay — higher than 10% of drugs with this benchmark

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00406-0124-05) — 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
$0.2352per unit
middle half $0.1848$0.3319 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $0.2352
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 3 · prior auth 2% · step therapy 0% · qty limit 96%

*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 6 quarters since 2024.

NADAC price per unit

$0$0.1$0.2Nov 2017Sep 2026$0.1389
105 price points · per EA · held since Invalid Date · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$4.17
#90 count
$12.50

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

Medicaid spend (2024)

$266
17 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)

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

OAI inspection at a producing facility (24 months) · 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
ANDA206245
TE code
Approval date
Dec 1, 2016
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class III · TerminatedMay 24, 2018
    LUPIN SOMERSETLabeling: Missing Label

Manufacturers of Hydrocodone Bitartrate and Acetaminophen (Tablet)

LabelerStrengthFirst seenLast seen
Asclemed USA, Inc.HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
Asclemed USA, Inc.HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
Bryant Ranch PrepackHYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
Bryant Ranch PrepackHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 3, 2026
Bryant Ranch PrepackHYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 3, 2026
Bryant Ranch PrepackHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
Bryant Ranch PrepackHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
Bryant Ranch PrepackHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 3, 2026
NuCare Pharmaceuticals,Inc.HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
NuCare Pharmaceuticals,Inc.HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
NuCare Pharmaceuticals,Inc.HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
Proficient Rx LPHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
SpecGx LLCHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 20, 2026Sep 3, 2026
St. Mary's Medical Park PharmacyHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
XLCare Pharmaceuticals, Inc.HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
XLCare Pharmaceuticals, Inc.HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
XLCare Pharmaceuticals, Inc.HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
XLCare Pharmaceuticals, Inc.HYDROCODONE BITARTRATE 2.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 3, 2026
A-S Medication SolutionsHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
American Health PackagingHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
American Health PackagingHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
American Health PackagingHYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCHYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Aurolife Pharma, LLCHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Aurolife Pharma, LLCHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 2, 2026
Aurolife Pharma, LLCHYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Aurolife Pharma, LLCHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 2, 2026
Aurolife Pharma, LLCHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Aurolife Pharma, LLCHYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 2, 2026
AvPAKHYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
AvPAKHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
AvPAKHYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.HYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.HYDROCODONE BITARTRATE 10 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.HYDROCODONE BITARTRATE 2.5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.HYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026
Cranbury Pharmaceuticals, LLCHYDROCODONE BITARTRATE 7.5 mg/1; ACETAMINOPHEN 300 mg/1Aug 26, 2026Sep 2, 2026
Cranbury Pharmaceuticals, LLCHYDROCODONE BITARTRATE 5 mg/1; ACETAMINOPHEN 325 mg/1Aug 26, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Hydrocodone Bitartrate and Acetaminophen — NDC 43386-0357-01," retrieved September 3, 2026, https://drugdashboards.com/drug/43386035701.

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