Medicine
Methylprednisolone 400 mg/5 mL injectable suspension
Methylprednisolone 400 mg/5 mL injectable suspension is a generic prescription medicine for intralesional, intramuscular, intrasynovial, soft tissue use, 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 controlled room temperature 20°C to 25°C (68°F to 77°F).
Key facts
- Active ingredient (INN)
- Methylprednisolone
- Brand
- Sold under the generic name
- Strength
- 400 mg/5 mL
- Dosage form
- Injectable suspension
- Route
- Intralesional, intramuscular, intrasynovial, soft tissue
- Packs
- 1 vial of 5 mL, 25 vials of 5 mL
- Manufacturer
- Gland PharmaIndia
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20°C to 25°C (68°F to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D07AA01 Methylprednisolone
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 November 2026
- Identifiers
- DailyMed set ID cfc2eaf8-7c99-4ce1-95cf-ba1dc0226aedNDC 68083-622Application ANDA219662
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 | 68083-622-01 | Gland PharmaIndia | 2 November 2026 |
| 25 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 68083-622-25 | Gland PharmaIndia | 2 November 2026 |
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 55150-314-01 | — | 13 April 2023 |
| 25 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 55150-314-25 | — | 13 April 2023 |
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 70121-1610-1 | — | 10 November 2023 |
| 25 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 70121-1610-5 | — | 10 November 2023 |
| 1 vial in 1 carton / 5 mL in 1 vial | 25021-821-05 | — | 15 November 2021 |
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 24 October 1957 | 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 Methylprednisolone 400 mg/5 mL injectable suspension.
Other strengths and forms of Methylprednisolone
Clinical summary
Methylprednisolone is a corticosteroid indicated in conditions. It is available as tablets, powder for injection and injectable suspension for intramuscular, intravenous and oral use. MedsAcross supplies Methylprednisolone 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 MethylprednisoloneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Methylprednisolone prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Methylprednisolone 400 mg/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.