Medicine
Theophylline 450 mg extended-release tablet
Theophylline 450 mg extended-release tablet is a generic prescription medicine for oral use, made by 13 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°-25°C (68°-77°F) Manufactured and Distributed by: Leading Pharma…
Key facts
- Active ingredient (INN)
- Theophylline
- Brand
- Sold under the generic name
- Strength
- 450 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 500 tablets and 20 more
- Manufacturers
- Alembic PharmaceuticalsIndiaGlenmark PharmaceuticalsIndiaAvet PharmaceuticalsIndiaAjanta PharmaIndiaCamber PharmaceuticalsIndiaStrides PharmaIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaAmneal PharmaceuticalsHarman Finochem
- Origin register
- US FDA, United States
- Storage
- Store at 20°-25°C (68°-77°F) Manufactured and Distributed by: Leading Pharma, LLC 3 Oak Rd, Fairfield, New Jersey (NJ) 07004 United States (USA) Rev. 02 02/22
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R03DA04 Theophylline
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 November 2010
- Identifiers
- RxCUI 314241, 317769DailyMed set ID ac490ebf-24e1-47c4-a932-ad4dcafe7aad, abdfb9b9-9402-4761-9347-8eb1c4d86242, 5e64036a-ee3e-42e7-9e59-881f88a4e298 +11NDC 69315-227, 72578-174, 72789-442 +11Application ANDA214950, ANDA218063, ANDA215312 +8
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, extended release in 1 bottle | 46708-026-30 | Alembic PharmaceuticalsIndia | 1 November 2010 |
| 100 tablet, extended release in 1 bottle | 46708-026-31 | Alembic PharmaceuticalsIndia | 1 November 2010 |
| 500 tablet, extended release in 1 bottle | 46708-026-71 | Alembic PharmaceuticalsIndia | 1 November 2010 |
| 30 tablet, extended release in 1 bottle | 62332-026-30 | Alembic PharmaceuticalsIndia | 29 January 2016 |
| 100 tablet, extended release in 1 bottle | 62332-026-31 | Alembic PharmaceuticalsIndia | 29 January 2016 |
| 500 tablet, extended release in 1 bottle | 62332-026-71 | Alembic PharmaceuticalsIndia | 29 January 2016 |
| 100 tablet, extended release in 1 bottle | 27241-273-01 | Ajanta PharmaIndia | 13 January 2025 |
| 100 tablet, extended release in 1 bottle | 23155-742-01 | Avet PharmaceuticalsIndia | 12 May 2022 |
| 500 tablet, extended release in 1 bottle | 23155-742-05 | Avet PharmaceuticalsIndia | 12 May 2022 |
| 100 tablet, extended release in 1 bottle | 31722-078-01 | Camber PharmaceuticalsIndia | 8 September 2023 |
| 100 tablet, extended release in 1 bottle | 68462-722-01 | Glenmark PharmaceuticalsIndia | 3 June 2021 |
| 500 tablet, extended release in 1 bottle | 68462-722-05 | Glenmark PharmaceuticalsIndia | 3 June 2021 |
| 30 tablet, extended release in 1 bottle | 68462-722-30 | Glenmark PharmaceuticalsIndia | 3 June 2021 |
| 100 tablet, extended release in 1 bottle | 64380-244-01 | Strides PharmaIndia | 27 September 2024 |
| 100 tablet, extended release in 1 bottle | 72578-174-01 | Viona PharmaceuticalsIndia | 25 May 2024 |
| 100 tablet, extended release in 1 bottle | 70771-1783-1 | Zydus LifesciencesIndia | 25 May 2024 |
| 100 tablet, extended release in 1 bottle, plastic | 60219-2046-1 | Amneal Pharmaceuticals | 27 March 2023 |
| 30 tablet, extended release in 1 bottle, plastic | 60219-2046-3 | Amneal Pharmaceuticals | 27 March 2023 |
| 500 tablet, extended release in 1 bottle, plastic | 60219-2046-5 | Amneal Pharmaceuticals | 27 March 2023 |
| 100 tablet, extended release in 1 bottle | 82638-106-02 | Harman Finochem | 30 July 2024 |
| 100 tablet, extended release in 1 bottle | 69315-227-01 | Leading Pharma | 15 May 2023 |
| 100 tablet, extended release in 1 bottle | 0480-3309-01 | Teva Pharmaceuticals | 27 January 2023 |
| 100 tablet, extended release in 1 bottle, plastic | 72789-442-01 | PD-Rx Pharmaceuticals | 16 October 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 17 October 1947 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Theophylline
Clinical summary
Theophylline is a methylxanthine 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. MedsAcross supplies Theophylline for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about TheophyllineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Theophylline prescribing information (Cranbury Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Theophylline 450 mg extended-release tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.