Medicine
Standardized Mite Dermatophagoides pteronyssinus 5000 AU/mL injection
Standardized Mite Dermatophagoides pteronyssinus 5000 AU/mL injection is a prescription medicine containing Dermatophagoides pteronyssinus for intradermal, percutaneous, subcutaneous use, marketed by Greer Laboratories, 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 dust mite extract at 2 to 8°C (36 to 46°F). Keep dust mite extract at 2…
Key facts
- Active ingredient (INN)
- Dermatophagoides pteronyssinus
- Brand
- Standardized Mite Dermatophagoides pteronyssinus
- Strength
- 5000 AU/mL
- Dosage form
- Injection
- Route
- Intradermal, percutaneous, subcutaneous
- Packs
- 10 mL, 50 mL
- Marketing authorisation holder
- Greer Laboratories
- Manufacturer
- Greer Laboratories
- Origin register
- US FDA, United States
- Storage
- Store dust mite extract at 2 to 8°C (36 to 46°F). Keep dust mite extract at 2 to 8°C (36 to 46°F) during office use.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 June 1989
- Identifiers
- RxCUI 852813, 852825, 852829 +4DailyMed set ID 9b7f878e-613f-4831-9223-a6a07fb09f1bNDC 22840-0035Application BLA101835
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 |
|---|---|---|---|
| 10 mL in 1 vial, multi-dose | 22840-0035-6 | Greer Laboratories | 27 June 1989 |
| 50 mL in 1 vial, multi-dose | 22840-0035-9 | Greer Laboratories | 27 June 1989 |
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 Dermatophagoides pteronyssinus
Clinical summary
Dermatophagoides pteronyssinus is a standardized insect allergenic extract indicated in the diagnosis of patients with a history of allergy to mites or house dust and for the treatment of patients with a history of mite allergy. MedsAcross supplies Dermatophagoides pteronyssinus 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 Dermatophagoides pteronyssinusFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- House Dust Mite, Dermatophagoides farinae prescribing information (Allermed Laboratories) · U.S. National Library of Medicine, DailyMed
Need Standardized Mite Dermatophagoides pteronyssinus 5000 AU/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.