Medicine
RhoGAM Ultra-Filtered PLUS 300 mcg injection
RhoGAM Ultra-Filtered PLUS 300 mcg injection is a prescription medicine containing Human rho(d) immune globulin for intramuscular use, marketed by Kedrion Biopharma, 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 at 2 to 8°C. Do not store frozen.
Key facts
- Active ingredient (INN)
- Human rho(d) immune globulin
- Brand
- RhoGAM Ultra-Filtered PLUS
- Strength
- 300 mcg
- Dosage form
- Injection
- Route
- Intramuscular
- Packs
- 1 pouch, 5 pouches, 25 pouches
- Marketing authorisation holder
- Kedrion Biopharma
- Manufacturer
- Kedrion Biopharma
- Origin register
- US FDA, United States
- Storage
- Store at 2 to 8°C. Do not store frozen.
- 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
- 9 March 2007
- Identifiers
- RxCUI 731380, 731381, 731383 +1DailyMed set ID d87e4d0b-2442-4135-b3f9-5c4f74845b87NDC 0562-7805Application BLA103777
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 |
|---|---|---|---|
| 1 pouch in 1 carton / 1 injection, solution in 1 pouch | 0562-7805-01 | Kedrion Biopharma | 9 March 2007 |
| 5 pouch in 1 carton / 1 injection, solution in 1 pouch | 0562-7805-05 | Kedrion Biopharma | 9 March 2007 |
| 25 pouch in 1 carton / 1 injection, solution in 1 pouch | 0562-7805-25 | Kedrion Biopharma | 9 March 2007 |
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 rho(d) immune globulin
Clinical summary
Human rho(d) immune globulin is a human immunoglobulin G indicated for the suppression of Rh isoimmunization in non-sensitized Rh(D)-negative patients and for the treatment of immune thrombocytopenic purpura (ITP) in Rh(D)-positive patients. MedsAcross supplies Human rho(d) immune globulin 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 rho(d) immune globulinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Rhophylac prescribing information (CSL Behring) · U.S. National Library of Medicine, DailyMed
Need RhoGAM Ultra-Filtered PLUS 300 mcg 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.