Quick answers
- What is Theophylline used for?
- The FDA-approved label (Theo-24, ENDO USA, Inc., July 8, 2024) says: “Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Theophylline have a boxed warning?
- No. None of the 27 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Theophylline?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Theophylline been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started August 8, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Theophylline?
- 26 companies list prescription products of Theophylline in the FDA NDC Directory, including Endo USA, Inc., Glenmark Pharmaceuticals Inc., USA and Proficient Rx LP.
What Theophylline is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
— FDA label: Theo-24, ENDO USA, Inc., effective July 8, 2024. Read the full label on DailyMed →
The FDA has 27 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 27 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, extended release · Solution · Capsule, extended release |
|---|---|
| Route | Oral |
| Prescription products | 51 in the FDA NDC Directory |
| Brand names | Theo-24 |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| theophylline 300 mg tablet, extended release | Generic | $0.3409 per tablet |
| theophylline 450 mg tablet, extended release | Generic | $1.11 per tablet |
| theophylline anhydrous 100 mg capsule, extended release | Brand: Theo-24 | $3.82 per capsule |
| theophylline anhydrous 200 mg capsule, extended release | Brand: Theo-24 | $5.67 per capsule |
| theophylline anhydrous 300 mg capsule, extended release | Brand: Theo-24 | $6.95 per capsule |
| theophylline anhydrous 300 mg tablet, extended release | Generic | $0.3409 per tablet |
| theophylline anhydrous 400 mg capsule, extended release | Brand: Theo-24 | $9.79 per capsule |
| theophylline anhydrous 400 mg tablet, extended release | Generic | $0.9488 per tablet |
| theophylline anhydrous 450 mg tablet, extended release | Generic | $1.11 per tablet |
| theophylline anhydrous 600 mg tablet, extended release | Generic | $1.40 per tablet |
| theophylline anhydrous 80 mg/15 mL solution | Generic | $0.1118 per mL |
NADAC list of November 4, 2026; these prices took effect between January 1, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Endo USA, Inc.4 products
- Glenmark Pharmaceuticals Inc., USA4 products
- Proficient Rx LP2 products
- Ajanta Pharma USA Inc.2 products
- Strides Pharma Science Limited2 products
- Camber Pharmaceuticals, Inc.2 products
- Amneal Pharmaceuticals LLC2 products
- Bryant Ranch Prepack2 products
- Viona Pharmaceuticals Inc2 products
- Harman Finochem Limited2 products
- Alembic Pharmaceuticals Limited2 products
- Golden State Medical Supply, Inc.2 products
- Alembic Pharmaceuticals Inc.2 products
- Zydus Lifesciences Limited2 products
- PD-Rx Pharmaceuticals, Inc.2 products
- Westminster Pharmaceuticals, LLC2 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2 products
- Chartwell RX, LLC2 products
- Teva Pharmaceuticals, Inc.2 products
- Leading Pharma, LLC2 products
- PAI Holdings, LLC dba PAI Pharma2 products
- Cranbury Pharmaceuticals, LLC1 product
- Chartwell Governmental & Specialty RX, LLC.1 product
- Bionpharma Inc.1 product
- AvKARE1 product
- Atlantic Biologicals Corp.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (22)
- ANDA087943Endo Operations · August 22, 1983
- ANDA089763Heritage Pharma Avet · April 30, 1990
- ANDA081236Heritage Pharma Avet · November 9, 1992
- ANDA040560Mpp Pharma · April 21, 2006
- ANDA090355Glenmark Pharms Ltd · July 13, 2010
- ANDA090430Alembic · October 27, 2010
- ANDA091156Chartwell Molecular · April 13, 2011
- ANDA091586Tris Pharma Inc · June 15, 2012
- ANDA206344Pharm Assoc · December 16, 2016
- ANDA212184Glenmark Pharms Ltd · June 3, 2021
- ANDA216961Teva Pharms Inc · October 12, 2022
- ANDA214950Velzen Pharma Pvt · January 30, 2023
- ANDA216276Amneal · March 20, 2023
- ANDA216300Bionpharma · April 26, 2023
- ANDA217422Annora Pharma · September 8, 2023
- ANDA214806Harman Finochem · October 24, 2023
- ANDA218063Zydus Lifesciences · May 21, 2024
- ANDA215312Strides Pharma · September 5, 2024
- ANDA218401Ajanta Pharma Ltd · January 13, 2025
- ANDA081034—
- ANDA087942—
- ANDA087944—
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 8, 2025 · Class II · Ongoing · D-0583-2025
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.
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, N — Glenmark Pharmaceuticals Inc., USA
-
May 15, 2025 · Class II · Ongoing · D-0452-2025
OOS results reported for the Dissolution (by UV) test.
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceutica — Glenmark Pharmaceuticals Inc., USA
-
March 15, 2021 · Class II · Terminated · D-0485-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC 68462-380-01 Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals — Cardinal Health Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Theo-24, ENDO USA, Inc., effective July 8, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →