DrugDashboards

Theophylline (Anhydrous)

Theophylline Anhydrous · THEOPHYLLINE ANHYDROUS 600 mg/1 · Tablet, Extended Release · Oral · Westminster Pharmaceuticals, LLC

NDC 69367-0415-01 · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. One of its named manufacturing plants, Mpp Pharma Llc, failed FDA inspectionwithin the last two years — the agency’s most serious outcome. 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)$1.40per EAinvoice-surveyed acquisition cost · Jan 14, 2026
  • Part D plans paid (avg)$5.50per dosage unitgross, before rebates — matched by drug name · 2024

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$0.5$1.00$1.50Jan 2026Jan 2026$1.40
1 price point · per EA · last surveyed Invalid DateSource: CMS NADAC

Estimated fill cost

#30 count
$41.85
#90 count
$125.56

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

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)

0.2%chance of a new FDA shortage posting for theophylline anhydrous (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market · price up 3% 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

  • Mpp Pharma LlcOAIUnited States
    analysis · label · manufacture · pack

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
ANDA040560
TE code
AB
Approval date
Apr 21, 2006
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 Theophylline Anhydrous (Tablet, Extended Release)

LabelerStrengthFirst seenLast seen
Westminster Pharmaceuticals, LLCTHEOPHYLLINE ANHYDROUS 400 mg/1Jul 15, 2026Sep 2, 2026
Westminster Pharmaceuticals, LLCTHEOPHYLLINE ANHYDROUS 600 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Theophylline (Anhydrous) — NDC 69367-0415-01," retrieved September 3, 2026, https://drugdashboards.com/drug/69367041501.

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