Medicine
Andexxa 200 mg/20 mL powder for injection
Andexxa 200 mg/20 mL powder for injection is a prescription medicine containing Andexanet alfa for intravenous use, marketed by AstraZeneca Pharmaceuticals, 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
DO NOT FREEZE. Prior to reconstitution Unopened vials should be stored…
Key facts
- Active ingredient (INN)
- Andexanet alfa
- Brand
- Andexxa
- Strength
- 200 mg/20 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 4 vials, 5 vials
- Marketing authorisation holder
- AstraZeneca Pharmaceuticals
- Manufacturer
- AstraZeneca Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- DO NOT FREEZE. Prior to reconstitution Unopened vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F) until the expiration date indicated on the label. After reconstitution • Reconstituted ANDEXXA in vials is stable at room temperature for up to 8 hours, or may be stored for up to 24 hours at 2°C to 8°C (36°F to 46°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- V03AB38 Andexanet alfa
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 July 2022
- Identifiers
- RxCUI 2108128, 2108130DailyMed set ID 2d9d90a6-63e6-46ef-96ff-dd6519ae7b6cNDC 0310-3200Application BLA125586
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 |
|---|---|---|---|
| 4 vial, single-use in 1 carton / 20 mL in 1 vial, single-use | 0310-3200-04 | AstraZeneca Pharmaceuticals | 12 July 2022 |
| 5 vial, single-use in 1 carton / 20 mL in 1 vial, single-use | 0310-3200-05 | AstraZeneca Pharmaceuticals | 3 July 2023 |
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.
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
Clinical summary
Andexanet alfa is a prescription medicine indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, among other approved uses. MedsAcross supplies Andexanet alfa 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 Andexanet alfaFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ANDEXXA prescribing information (AstraZeneca Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Ondexxya: European public assessment report (EPAR) · European Medicines Agency
Need Andexxa 200 mg/20 mL powder for 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.