Medicine
Theophylline 80 mg/15 mL oral solution
Theophylline 80 mg/15 mL oral solution is a generic prescription medicine for oral use, made by 6 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° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Theophylline
- Brand
- Sold under the generic name
- Strength
- 80 mg/15 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 118 mL, 473 mL, 4 trays and 7 more
- Manufacturers
- PAI PharmaBryant Ranch PrepackChartwell RXAtlantic BiologicalsChartwell Governmental & Specialty RXCranbury Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- 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
- 13 April 2011
- Identifiers
- RxCUI 313306DailyMed set ID 32b9780f-c46f-4e0f-9641-2cab60600e6e, 1b685384-5d96-46fa-b93b-e96538a2cfe7, 62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd +4NDC 0121-0820, 62135-556, 71335-2909 +5Application ANDA206344, ANDA091156, ANDA091586
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 |
|---|---|---|---|
| 118 mL in 1 bottle | 0121-0820-04 | PAI Pharma | 16 December 2016 |
| 473 mL in 1 bottle | 0121-0820-16 | PAI Pharma | 16 December 2016 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose | 0121-4820-40 | PAI Pharma | 16 December 2016 |
| 2 tray in 1 box / 10 cup in 1 tray / 15 mL in 1 cup | 68999-556-24 | Chartwell Governmental & Specialty RX | 13 November 2025 |
| 2 tray in 1 box / 10 cup in 1 tray / 15 mL in 1 cup | 62135-556-24 | Chartwell RX | 31 May 2024 |
| 473 mL in 1 bottle | 62135-556-47 | Chartwell RX | 27 October 2022 |
| 473 mL in 1 bottle | 27808-033-01 | Cranbury Pharmaceuticals | 2 August 2012 |
| 473 mL in 1 bottle | 71335-2909-1 | Bryant Ranch Prepack | 22 October 2025 |
| 473 mL in 1 bottle | 72162-2038-2 | Bryant Ranch Prepack | 6 June 2023 |
| 50 cup, unit-dose in 1 box, unit-dose / 15 mL in 1 cup, unit-dose | 17856-0038-1 | Atlantic Biologicals | 9 May 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 80 mg/15 mL oral solution 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.