Medicine
Terbutaline 5 mg tablet
Terbutaline 5 mg tablet 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)
- Terbutaline
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 90 tablets and 10 more
- Manufacturers
- Proficient RxAmneal Pharmaceuticals of New YorkLannettUpsher-Smith LaboratoriesANI PharmaceuticalsChartwell RX
- 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
- R03AC03 Terbutaline
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 June 2001
- Identifiers
- RxCUI 857677, 857683DailyMed set ID 382dcebb-6e41-4335-818d-b5822e3fb884, 0a95bc4f-34d3-4b5e-841b-6839e1c1e0c7, 859267c6-3d14-4123-9b9d-4fc248f09726 +3NDC 0115-2622, 71205-939, 62135-525 +3Application ANDA075877, ANDA211832, ANDA077152 +1
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 0115-2622-01 | Amneal Pharmaceuticals of New York | 26 June 2001 |
| 500 tablet in 1 bottle | 0115-2622-02 | Amneal Pharmaceuticals of New York | 26 June 2001 |
| 100 tablet in 1 bottle | 62559-722-01 | ANI Pharmaceuticals | 16 October 2018 |
| 90 tablet in 1 bottle | 62135-525-90 | Chartwell RX | 28 February 2023 |
| 100 tablet in 1 bottle | 0527-1311-01 | Lannett | 25 March 2005 |
| 1000 tablet in 1 bottle | 0527-1311-10 | Lannett | 25 March 2005 |
| 100 tablet in 1 bottle | 24979-133-01 | Upsher-Smith Laboratories | 13 July 2020 |
| 1000 tablet in 1 bottle | 24979-133-03 | Upsher-Smith Laboratories | 13 July 2020 |
| 100 tablet in 1 bottle | 71205-939-00 | Proficient Rx | 19 November 2020 |
| 30 tablet in 1 bottle | 71205-939-30 | Proficient Rx | 19 November 2020 |
| 500 tablet in 1 bottle | 71205-939-55 | Proficient Rx | 19 November 2020 |
| 60 tablet in 1 bottle | 71205-939-60 | Proficient Rx | 19 November 2020 |
| 90 tablet in 1 bottle | 71205-939-90 | Proficient Rx | 19 November 2020 |
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 25 March 1974 | 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 Terbutaline
Clinical summary
Terbutaline is a prescription medicine indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema. MedsAcross supplies Terbutaline 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 TerbutalineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Terbutaline Sulfate prescribing information (ANI Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Terbutaline 5 mg 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.