DrugDashboards

Theophylline

Theophylline · THEOPHYLLINE 80 mg/15mL · Solution · Oral · PAI Holdings, LLC dba PAI Pharma

NDC 00121-0820-04 · 118 mL in 1 BOTTLE · ANDA · View full market →

The short version

6 companies supply this market — a reasonable cushion if one runs into trouble.

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

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 (other) in the next 90 days

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

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

Regulatory

Application
ANDA206344
TE code
Approval date
Dec 16, 2016
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 (Solution)

LabelerStrengthFirst seenLast seen
Bryant Ranch PrepackTHEOPHYLLINE ANHYDROUS 80 mg/15mLJul 15, 2026Sep 3, 2026
Atlantic Biologicals Corp.THEOPHYLLINE ANHYDROUS 80 mg/15mLJul 15, 2026Sep 2, 2026
Chartwell Governmental & Specialty RX, LLC.THEOPHYLLINE ANHYDROUS 80 mg/15mLJul 15, 2026Sep 2, 2026
Chartwell RX, LLCTHEOPHYLLINE ANHYDROUS 80 mg/15mLJul 15, 2026Sep 2, 2026
Cranbury Pharmaceuticals, LLCTHEOPHYLLINE ANHYDROUS 80 mg/15mLJul 15, 2026Sep 2, 2026
PAI Holdings, LLC dba PAI PharmaTHEOPHYLLINE 80 mg/15mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Theophylline — NDC 00121-0820-04," retrieved September 3, 2026, https://drugdashboards.com/drug/00121082004.

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