Neurolite kit is a prescription medicine containing Bicisate, marketed by Shine Spect, 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 after preparation.
Key facts
- Active ingredient (INN)
- Bicisate
- Brand
- Neurolite
- Dosage form
- Kit
- Packs
- 2 kits, 5 kits and 1 more
- Marketing authorisation holder
- Shine Spect
- Manufacturers
- Shine SpectLantheus Medical Imaging
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature after preparation.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 November 1994
- Identifiers
- DailyMed set ID f9adbcd5-1ac1-42d8-b18a-a76c9204014c, e2c9efae-4e57-4f05-ac72-5443dea03f38NDC 11994-006, 87333-006Application NDA020256
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 |
|---|---|---|---|
| 2 kit in 1 package, combination / 1 kit in 1 kit * 1 injection in 1 vial * 1 mL in 1 vial | 87333-006-02 | Shine Spect | 10 September 2026 |
| 5 kit in 1 package, combination / 1 kit in 1 kit * 1 injection in 1 vial * 1 mL in 1 vial | 87333-006-05 | Shine Spect | 10 September 2026 |
| 2 kit in 1 package, combination / 1 kit in 1 kit * 1 injection in 1 vial * 1 mL in 1 vial | 11994-006-02 | Lantheus Medical Imaging | 23 November 1994 |
| 5 kit in 1 package, combination / 1 kit in 1 kit * 1 injection in 1 vial * 1 mL in 1 vial | 11994-006-05 | Lantheus Medical Imaging | 23 November 1994 |
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
Clinical summary
Bicisate is a prescription medicine indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed, among other approved uses. MedsAcross supplies Bicisate 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 BicisateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- NEUROLITE prescribing information (Shine Spect) · U.S. National Library of Medicine, DailyMed
Need Neurolite kit 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.