DrugDashboards

Potassium Citrate and Citric Acid

Potassium Citrate and Citric Acid Monohydrate · POTASSIUM CITRATE 1100 mg/5mL; CITRIC ACID MONOHYDRATE 334 mg/5mL · Solution · Oral · PAI Holdings, LLC dba PAI Pharma

NDC 00121-0676-16 · 473 mL in 1 BOTTLE · UNAPPROVED DRUG OTHER · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. The price has held steady around $0.0541 per mL over the past year. 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.

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$0.05$0.1Aug 2015Sep 2026$0.0541
98 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$35.60
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.

Medicaid spend (2025)

$262,407
6,448 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

30Elevated risk

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

  • 1 active manufacturer+30

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 potassium citrate and citric acid monohydrate (other) in the next 90 days

price up 12% YoY

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 · Xywav and Xyrem

Regulatory

Application
TE code
Approval date
Patents / exclusivity

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Potassium Citrate and Citric Acid Monohydrate (Solution)

LabelerStrengthFirst seenLast seen
PAI Holdings, LLC dba PAI PharmaPOTASSIUM CITRATE 1100 mg/5mL; CITRIC ACID MONOHYDRATE 334 mg/5mLAug 26, 2026Sep 2, 2026
PAI Holdings, LLC dba PAI PharmaPOTASSIUM CITRATE 334 mg/5mL; CITRIC ACID MONOHYDRATE 1100 mg/5mLJul 22, 2026Aug 19, 2026
PAI Holdings, LLC dba PAI PharmaCITRIC ACID MONOHYDRATE 334 mg/5mL; POTASSIUM CITRATE 1100 mg/5mLJul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Potassium Citrate and Citric Acid — NDC 00121-0676-16," retrieved September 3, 2026, https://drugdashboards.com/drug/00121067616.

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