DrugDashboards

Cromolyn Sodium

Cromolyn Sodium · CROMOLYN SODIUM 100 mg/5mL · Solution, Concentrate · Oral · Omnivium Pharmaceuticals LLC

NDC 81665-0104-96 · 12 POUCH in 1 CARTON / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE · ANDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately. The price is up 25% over the past year, to $0.3357 per mL. It is in shortage right now. 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)$0.3357per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$1.23per dosage unitgross, before rebates — matched by drug name · 2024
  • Medicaid generic ceiling (FUL)$0.5577per MLweighted avg manufacturer price $0.3187 · Aug 1, 2026166% of what pharmacies pay — higher than 81% of drugs with this benchmark

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 42571-0132-52) — 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
$0.3663per unit
middle half $0.3265$0.4801 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $0.3663
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 4 · prior auth 0% · step therapy 0% · qty limit 0%

*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 10 quarters since 2024.

NADAC price per unit

$0$0.25$0.5$0.75Feb 2025Sep 2026$0.3357
12 price points · per ML · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

WAC per package, as filed
$200.00
Reported to Texas DSHS · 2026 annual filing · Omnivium Pharmaceuticals, LLC

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

Medicaid spend (2025)

$1.3M
4,523 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

35Elevated risk

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

  • 3 active manufacturers+10
  • in shortage now+25

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 cromolyn sodium (other) in the next 90 days

price up 25% 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 →

Regulatory

Application
ANDA209264
TE code
AA
Approval date
Oct 16, 2017
Patents / exclusivity
None on file

Shortage history

  • In shortage now Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 16571-600-96)Nov 3, 2023
    month 35 — 3× the typical 12-month other shortage · model puts 49% odds it resolves within 6 months
  • In shortage now Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 42571-132-52)Nov 3, 2023
    month 35 — 3× the typical 12-month other shortage · model puts 49% odds it resolves within 6 months
  • In shortage now Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 81665-104-96)Nov 3, 2023
    month 35 — 3× the typical 12-month other shortage · model puts 49% odds it resolves within 6 months

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Cromolyn Sodium (Solution, Concentrate)

LabelerStrengthFirst seenLast seen
Micro Labs LimitedCROMOLYN SODIUM 100 mg/5mLJul 15, 2026Sep 2, 2026
Omnivium Pharmaceuticals LLCCROMOLYN SODIUM 100 mg/5mLJul 15, 2026Sep 2, 2026
Rising Pharma Holdings, Inc.CROMOLYN SODIUM 100 mg/5mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Cromolyn Sodium — NDC 81665-0104-96," retrieved September 3, 2026, https://drugdashboards.com/drug/81665010496.

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