Medicine
Betamethasone 15 mg/15 mg per 5 mL injectable suspension
Betamethasone 15 mg/15 mg per 5 mL injectable suspension is a generic prescription medicine for intra-articular, intralesional, intramuscular use, made by 2 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), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Betamethasone
- Brand
- Sold under the generic name
- Strength
- 15 mg/15 mg per 5 mL
- Dosage form
- Injectable suspension
- Route
- Intra-articular, intralesional, intramuscular
- Packs
- 1 vial of 5 mL, 5 mL and 1 more
- Manufacturers
- American RegentAsclemed
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A07EA04 Betamethasone
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 April 2010
- Identifiers
- RxCUI 578803DailyMed set ID a363b861-4873-465e-8009-0e9690666224, c0a09d83-2405-450b-9f35-803d12823213, 335f17e7-069d-456c-8507-26253692f2ee +1NDC 0517-0720, 76420-007, 0517-0791 +1Application ANDA090747
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 |
|---|---|---|---|
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 0517-0720-01 | American Regent | 28 April 2010 |
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 0517-0791-01 | American Regent | 1 November 2019 |
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 0517-0799-01 | American Regent | 1 November 2019 |
| 5 mL in 1 vial, multi-dose | 76420-007-05 | Asclemed | 16 January 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 17 April 1961 | 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
Alternatives
Other makers and brands of Betamethasone 15 mg/15 mg per 5 mL injectable suspension.
Clinical summary
Betamethasone is a corticosteroid indicated as follows, among other approved uses. It is available as injectable suspension for intra-articular, intralesional and intramuscular use. MedsAcross supplies Betamethasone 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 BetamethasoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- CELESTONE SOLUSPAN prescribing information (Organon) · U.S. National Library of Medicine, DailyMed
Need Betamethasone 15 mg/15 mg per 5 mL injectable suspension 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.