Medicine
Megatope 1 mCi/mL injection
Megatope 1 mCi/mL injection is a prescription medicine containing Human serum albumin i-131 for intravenous use, marketed by Iso-Tex Diagnostics, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store refrigerated at 2º to 8ºC (36° to 46°F) in suitable lead shield.
Key facts
- Active ingredient (INN)
- Human serum albumin i-131
- Brand
- Megatope
- Strength
- 1 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 8 mL
- Marketing authorisation holder
- Iso-Tex Diagnostics
- Manufacturer
- Iso-Tex Diagnostics
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2º to 8ºC (36° to 46°F) in suitable lead shield.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 May 1996
- Identifiers
- DailyMed set ID 62ca4278-8cc9-46b7-8f3c-303ce6a9c155NDC 50914-7731Application BLA017837
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 8 mL in 1 vial, multi-dose | 50914-7731-4 | Iso-Tex Diagnostics | 21 May 1996 |
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 |
| 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 Human serum albumin i-131
Clinical summary
Human serum albumin i-131 is a prescription medicine indicated in adults for use in determinations of total blood and plasma volumes. It is available as injection for intravenous use. MedsAcross supplies Human serum albumin i-131 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 Human serum albumin i-131For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Megatope prescribing information (Iso-Tex Diagnostics) · U.S. National Library of Medicine, DailyMed
Need Megatope 1 mCi/mL injection 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.