Theophylline is a methylxanthine sold in the U.S. under 5 brand and generic names, for apnea, asthma and bradycardia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Labid (application ANDA087225). Other theophylline products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
General Considerations: The steady-state peak serum theophylline concentration is a function of the dose, the dosing interval, and the rate of theophylline absorption and clearance in the individual patient. Because of marked individual differences in the rate of theophylline clearance, the dose required to achieve a peak serum theophylline concentration in the 10 to 20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter theophylline clearance (e.g., 400 to 1600 mg/day in adults < 60 years old and 10 to 36 mg/kg/day in children 1 to 9 years old). For a given population there is no single theophylline dose that will provide both safe and effective serum concentrations for all patients. Administration of the median theophylline dose required to achieve a therapeutic serum theophylline concentration in a given population may result in either sub-therapeutic or potentially toxic serum theophylline concentrations in individual patients. For example, at a dose of 900 mg/d in adults < 60 years or 22 mg/kg/d in children 1 to 9 years, the steady-state peak serum theophylline concentration will be < 10 mcg/mL in about 30% of patients, 10 to 20 mcg/mL in about 50% and 20 to 30 mcg/mL in about 20% of patients. The dose of theophylline must be individualized on the basis of peak serum theophylline concentration measurements in order to…
associated with theophylline are generally mild when peak serum theophylline concentrations are < 20 mcg/mL and mainly consist of transient caffeine-like adverse effects such as nausea, vomiting, headache, and insomnia. When peak serum theophylline concentrations exceed 20 mcg/mL, however, theophylline produces a wide range of adverse reactions including persistent vomiting, cardiac arrhythmias, and intractable seizures which can be lethal (see OVERDOSAGE ). The transient caffeine-like adverse reactions occur in about 50% of patients when theophylline therapy is initiated at doses higher than recommended initial doses (e.g., > 300 mg/day in adults and > 12 mg/kg/day in children beyond > 1 year of age). During the initiation of theophylline therapy, caffeine-like adverse effects may transiently alter patient behavior, especially in school age children, but this response rarely persists. Initiation of theophylline therapy at a low dose with subsequent slow titration to a predetermined age-related maximum dose will significantly reduce the frequency of these transient adverse effects (see DOSAGE AND ADMINISTRATION, Table V ). In a small percentage of patients (< 3% of children and < 10% of adults) the caffeine-like adverse effects persist during maintenance therapy, even at peak serum theophylline concentrations within the therapeutic range (i.e., 10 to 20…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Tablet | Generic | $1 | View → | |
| 2 | 54/100 | Prescription | Injectable | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| T;1 | 300 mg | white | capsule | — |
| T;2 | 450 mg | white | capsule | — |
| N;T4 | 400 mg | white | round | — |
| NT6 | 600 mg | white | oval | — |
| T;1 | 300 mg | white | capsule | — |
| T;2 | 450 mg | white |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Theophylline extended-release tablets 400mg
Failed 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.
Glenmark Pharmaceuticals Inc., USA · Aug 8, 2025
Theophylline (Anhydrous) Extended-Release Tablets
OOS results reported for the Dissolution (by UV) test.
Glenmark Pharmaceuticals Inc., USA · May 15, 2025
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Theophylline oral solution is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.
| $1 |
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| 3 | Not yet rated | Prescription | Capsule | Generic | $1 | View → |
| 4 | Not yet rated | Prescription | Capsule | Generic | $1 | View → |
| 5 | Not yet rated | Prescription | Solution | Generic | $1 | View → |
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