DrugDashboards

Theophylline

Theophylline · THEOPHYLLINE ANHYDROUS 400 mg/1 · Tablet, Extended Release · Oral · Glenmark Pharmaceuticals Inc., USA

NDC 68462-0380-01 · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

18 companies supply this market — deep enough that no single failure threatens the supply. The price has jumped 33% in a year, to $1.02 per unit — sharp rises like this often mean supply is already tightening. 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)$1.02per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$0.1300per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$0.8426per unitnegotiated price across 5,490 plans — before rebates · Apr 1, 2026
  • Medicaid generic ceiling (FUL)$0.7065per TABweighted avg manufacturer price $0.1434 · Aug 1, 202270% of what pharmacies pay — a deeper discount than 95% of drugs with this benchmark

Medicare Part D

All Part D pricing →
ⓘ 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
$0.8426per unit
middle half $0.6910$1.11 · 5,490 plans · Apr 1, 2026
Est. net of rebates
≈ $0.8426
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 2 · 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$0.5$1.00$1.50Nov 2013Sep 2026$1.02
135 price points · per EA · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$30.45
#90 count
$91.36

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

Medicaid spend (2025)

$91,388
2,781 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)

0.1%chance of a new FDA shortage posting for theophylline (oral solid) in the next 90 days

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 →

Regulatory

Application
ANDA090355
TE code
AB
Approval date
Jul 13, 2010
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingAug 8, 2025
    Glenmark Pharmaceuticals Inc., USAFailed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
  • Class II · OngoingMay 15, 2025
    Glenmark Pharmaceuticals Inc., USAOOS results reported for the Dissolution (by UV) test.
  • Class II · TerminatedMar 15, 2021
    Cardinal Health Inc.CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Manufacturers of Theophylline (Tablet, Extended Release)

LabelerStrengthFirst seenLast seen
Ajanta Pharma USA Inc.THEOPHYLLINE ANHYDROUS 450 mg/1Jul 15, 2026Sep 2, 2026
Ajanta Pharma USA Inc.THEOPHYLLINE ANHYDROUS 300 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals Inc.THEOPHYLLINE ANHYDROUS 300 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals Inc.THEOPHYLLINE ANHYDROUS 450 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedTHEOPHYLLINE ANHYDROUS 450 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedTHEOPHYLLINE ANHYDROUS 300 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals NY LLCTHEOPHYLLINE ANHYDROUS 450 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals NY LLCTHEOPHYLLINE ANHYDROUS 300 mg/1Jul 15, 2026Sep 2, 2026
AvKARETHEOPHYLLINE ANHYDROUS 300 mg/1Jul 15, 2026Sep 2, 2026
Bionpharma Inc.,THEOPHYLLINE ANHYDROUS 300 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.THEOPHYLLINE ANHYDROUS 450 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.THEOPHYLLINE ANHYDROUS 300 mg/1Jul 15, 2026Sep 2, 2026
Chartwell RX, LLCTHEOPHYLLINE ANHYDROUS 300 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USATHEOPHYLLINE ANHYDROUS 400 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USATHEOPHYLLINE ANHYDROUS 600 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USATHEOPHYLLINE ANHYDROUS 450 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USATHEOPHYLLINE ANHYDROUS 300 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.THEOPHYLLINE ANHYDROUS 600 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.THEOPHYLLINE ANHYDROUS 400 mg/1Jul 15, 2026Sep 2, 2026
Harman Finochem LimitedTHEOPHYLLINE ANHYDROUS 300 mg/1Jul 15, 2026Sep 2, 2026
Harman Finochem LimitedTHEOPHYLLINE ANHYDROUS 450 mg/1Jul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.THEOPHYLLINE ANHYDROUS 300 mg/1Jul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.THEOPHYLLINE ANHYDROUS 450 mg/1Jul 15, 2026Sep 2, 2026
Leading Pharma, LLCTHEOPHYLLINE 300 mg/1Jul 15, 2026Sep 2, 2026
Leading Pharma, LLCTHEOPHYLLINE 450 mg/1Jul 15, 2026Sep 2, 2026
PD-Rx Pharmaceuticals, Inc.THEOPHYLLINE ANHYDROUS 450 mg/1Jul 15, 2026Sep 2, 2026
PD-Rx Pharmaceuticals, Inc.THEOPHYLLINE ANHYDROUS 300 mg/1Jul 15, 2026Sep 2, 2026
Strides Pharma Science LimitedTHEOPHYLLINE ANHYDROUS 450 mg/1Jul 15, 2026Sep 2, 2026
Strides Pharma Science LimitedTHEOPHYLLINE ANHYDROUS 300 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals, Inc.THEOPHYLLINE 300 mg/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals, Inc.THEOPHYLLINE 450 mg/1Jul 15, 2026Sep 2, 2026
Viona Pharmaceuticals IncTHEOPHYLLINE ANHYDROUS 450 mg/1Jul 15, 2026Sep 2, 2026
Viona Pharmaceuticals IncTHEOPHYLLINE ANHYDROUS 300 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedTHEOPHYLLINE ANHYDROUS 300 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedTHEOPHYLLINE ANHYDROUS 450 mg/1Jul 15, 2026Sep 2, 2026
Brandywine Pharmaceuticals, LLCTHEOPHYLLINE ANHYDROUS 300 mg/1Jul 15, 2026Jul 29, 2026
Brandywine Pharmaceuticals, LLCTHEOPHYLLINE ANHYDROUS 200 mg/1Jul 15, 2026Jul 29, 2026
Brandywine Pharmaceuticals, LLCTHEOPHYLLINE ANHYDROUS 100 mg/1Jul 15, 2026Jul 29, 2026

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

Cite this page

DrugDashboards, "Theophylline — NDC 68462-0380-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68462038001.

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