DrugDashboards

Theophylline

Theophylline · THEOPHYLLINE ANHYDROUS 450 mg/1 · Tablet, Extended Release · Oral · Harman Finochem Limited

NDC 82638-0106-02 · 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 numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 62332-0026-31) — 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
$1.98per unit
middle half $1.30$2.74 · 5,246 plans · Apr 1, 2026
Est. net of rebates
≈ $1.98
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
95%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

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

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 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
ANDA214806
TE code
AB
Approval date
Oct 24, 2023
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 (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 82638-0106-02," retrieved September 3, 2026, https://drugdashboards.com/drug/82638010602.

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