DrugDashboards

Hydrocodone Bitartrate and Acetaminophen

HYDROCODONE BITARTRATE and ACETAMINOPHEN · HYDROCODONE BITARTRATE 5 mg/10mL; ACETAMINOPHEN 217 mg/10mL · Solution · Oral · PAI Holdings, LLC dba PAI Pharma

NDC 00121-1544-40 · 4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE · ANDA · View full market →

The short version

7 companies supply this market — a reasonable cushion if one runs into trouble.

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.

  • Federal contracts pay (FSS)$372.53per package of 40x10MLGolden State Medical Supply, Inc. · Oct 31, 2025
  • List price (WAC, as filed)$376.29per packagePharmaceutical Associates Inc. · Dec 11, 2023

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

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

Estimated fill cost

WAC per package, as filed
$376.29
Reported to Texas DSHS · 2026 annual filing · PAI Holdings LLC dba Pharmaceutical Associates, Inc. / PAI Pharma

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

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 and acetaminophen (other) in the next 90 days

price up 13% YoY · 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
ANDA040838
TE code
AA
Approval date
May 10, 2013
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 and ACETAMINOPHEN (Solution)

LabelerStrengthFirst seenLast seen
Genus Lifesciences Inc.HYDROCODONE BITARTRATE 7.5 mg/15mL; ACETAMINOPHEN 325 mg/15mLAug 26, 2026Sep 3, 2026
American Health PackagingHYDROCODONE BITARTRATE 7.5 mg/15mL; ACETAMINOPHEN 325 mg/15mLAug 26, 2026Sep 2, 2026
Cranbury Pharmaceuticals, LLCHYDROCODONE BITARTRATE 10 mg/15mL; ACETAMINOPHEN 300 mg/15mLAug 26, 2026Sep 2, 2026
Cranbury Pharmaceuticals, LLCHYDROCODONE BITARTRATE 7.5 mg/15mL; ACETAMINOPHEN 325 mg/15mLAug 26, 2026Sep 2, 2026
Eywa Pharma IncHYDROCODONE BITARTRATE 7.5 mg/15mL; ACETAMINOPHEN 325 mg/15mLAug 26, 2026Sep 2, 2026
PAI Holdings, LLC dba PAI PharmaHYDROCODONE BITARTRATE 2.5 mg/5mL; ACETAMINOPHEN 108 mg/5mLAug 26, 2026Sep 2, 2026
PAI Holdings, LLC dba PAI PharmaHYDROCODONE BITARTRATE 5 mg/10mL; ACETAMINOPHEN 217 mg/10mLAug 26, 2026Sep 2, 2026
PAI Holdings, LLC dba PAI PharmaHYDROCODONE BITARTRATE 7.5 mg/15mL; ACETAMINOPHEN 325 mg/15mLAug 26, 2026Sep 2, 2026
Redpharm drugHYDROCODONE BITARTRATE 7.5 mg/15mL; ACETAMINOPHEN 325 mg/15mLAug 26, 2026Sep 2, 2026
Redpharm DrugHYDROCODONE BITARTRATE 7.5 mg/15mL; ACETAMINOPHEN 325 mg/15mLAug 26, 2026Sep 2, 2026
Genus Lifesciences Inc.HYDROCODONE BITARTRATE 325 mg/15mL; ACETAMINOPHEN 7.5 mg/15mLJul 22, 2026Aug 21, 2026
American Health PackagingHYDROCODONE BITARTRATE 325 mg/15mL; ACETAMINOPHEN 7.5 mg/15mLJul 22, 2026Aug 19, 2026
Cranbury Pharmaceuticals, LLCHYDROCODONE BITARTRATE 300 mg/15mL; ACETAMINOPHEN 10 mg/15mLJul 22, 2026Aug 19, 2026
Cranbury Pharmaceuticals, LLCHYDROCODONE BITARTRATE 325 mg/15mL; ACETAMINOPHEN 7.5 mg/15mLJul 22, 2026Aug 19, 2026
Eywa Pharma IncHYDROCODONE BITARTRATE 325 mg/15mL; ACETAMINOPHEN 7.5 mg/15mLJul 22, 2026Aug 19, 2026
PAI Holdings, LLC dba PAI PharmaHYDROCODONE BITARTRATE 325 mg/15mL; ACETAMINOPHEN 7.5 mg/15mLJul 22, 2026Aug 19, 2026
PAI Holdings, LLC dba PAI PharmaHYDROCODONE BITARTRATE 108 mg/5mL; ACETAMINOPHEN 2.5 mg/5mLJul 22, 2026Aug 19, 2026
PAI Holdings, LLC dba PAI PharmaHYDROCODONE BITARTRATE 217 mg/10mL; ACETAMINOPHEN 5 mg/10mLJul 22, 2026Aug 19, 2026
Redpharm drugHYDROCODONE BITARTRATE 325 mg/15mL; ACETAMINOPHEN 7.5 mg/15mLJul 22, 2026Aug 19, 2026
Redpharm DrugHYDROCODONE BITARTRATE 325 mg/15mL; ACETAMINOPHEN 7.5 mg/15mLJul 22, 2026Aug 19, 2026
Genus Lifesciences Inc.ACETAMINOPHEN 325 mg/15mL; HYDROCODONE BITARTRATE 7.5 mg/15mLJul 15, 2026Jul 19, 2026
American Health PackagingACETAMINOPHEN 325 mg/15mL; HYDROCODONE BITARTRATE 7.5 mg/15mLJul 15, 2026Jul 15, 2026
Cranbury Pharmaceuticals, LLCACETAMINOPHEN 325 mg/15mL; HYDROCODONE BITARTRATE 7.5 mg/15mLJul 15, 2026Jul 15, 2026
Cranbury Pharmaceuticals, LLCACETAMINOPHEN 300 mg/15mL; HYDROCODONE BITARTRATE 10 mg/15mLJul 15, 2026Jul 15, 2026
Eywa Pharma IncACETAMINOPHEN 325 mg/15mL; HYDROCODONE BITARTRATE 7.5 mg/15mLJul 15, 2026Jul 15, 2026
PAI Holdings, LLC dba PAI PharmaACETAMINOPHEN 217 mg/10mL; HYDROCODONE BITARTRATE 5 mg/10mLJul 15, 2026Jul 15, 2026
PAI Holdings, LLC dba PAI PharmaACETAMINOPHEN 325 mg/15mL; HYDROCODONE BITARTRATE 7.5 mg/15mLJul 15, 2026Jul 15, 2026
PAI Holdings, LLC dba PAI PharmaACETAMINOPHEN 108 mg/5mL; HYDROCODONE BITARTRATE 2.5 mg/5mLJul 15, 2026Jul 15, 2026
Redpharm drugACETAMINOPHEN 325 mg/15mL; HYDROCODONE BITARTRATE 7.5 mg/15mLJul 15, 2026Jul 15, 2026
Redpharm DrugACETAMINOPHEN 325 mg/15mL; HYDROCODONE BITARTRATE 7.5 mg/15mLJul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Hydrocodone Bitartrate and Acetaminophen — NDC 00121-1544-40," retrieved September 3, 2026, https://drugdashboards.com/drug/00121154440.

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