Medicine
Fluorescein 500 mg/5 mL injection
Fluorescein 500 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 4 labelers, 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
Do not freeze. Store fluorescein injection at 20°C to 25°C (68°F to 77°F).
Key facts
- Active ingredient (INN)
- Fluorescein
- Brand
- Sold under the generic name
- Strength
- 500 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 12 vials of 5 mL, 10 vials of 5 mL, 12 pouches of 5 mL and 2 more
- Manufacturers
- Zydus LifesciencesIndiaAnthea PharmaIndiaBPI LabsHealthFirst
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store fluorescein injection at 20°C to 25°C (68°F to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- S01JA01 Fluorescein
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 May 2021
- Identifiers
- DailyMed set ID 770582e3-c99b-4a02-868c-29309013717e, 19aea137-3f47-4b69-9884-3bff5f79b04a, 5c88e2a2-b05c-46f2-9874-c935e4b96a6e +2NDC 54288-179, 70710-2045, 70771-1969 +2Application ANDA220046, ANDA218651, NDA022186
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 12 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 70710-2045-9 | Zydus LifesciencesIndia | 2 June 2026 |
| 12 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 70771-1969-9 | Zydus LifesciencesIndia | 2 June 2026 |
| 12 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 83854-048-12 | Anthea PharmaIndia | 14 October 2026 |
| 10 vial, glass in 1 carton / 5 mL in 1 vial, glass | 54288-179-10 | BPI Labs | 20 May 2026 |
| 12 pouch in 1 box / 1 vial, single-dose in 1 pouch / 5 mL in 1 vial, single-dose | 51662-1533-3 | HealthFirst | 10 May 2021 |
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 |
| US FDA | First approved 10 November 1976 | Drugs@FDA |
| 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
Alternatives
Other makers and brands of Fluorescein 500 mg/5 mL injection.
Other strengths and forms of Fluorescein
Clinical summary
Fluorescein is a diagnostic dye indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. It is available as injection for intravenous and ophthalmic use. MedsAcross supplies Fluorescein 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 FluoresceinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- FLUORESCITE prescribing information (Alcon) · U.S. National Library of Medicine, DailyMed
Need Fluorescein 500 mg/5 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.