Medicine
Loteprednol etabonate 5 mg/mL ophthalmic suspension
Loteprednol etabonate 5 mg/mL ophthalmic suspension is a generic prescription medicine for ophthalmic use, made by 8 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 upright between 15°-25°C (59°-77°F).
Key facts
- Active ingredient (INN)
- Loteprednol etabonate
- Brand
- Sold under the generic name
- Strength
- 5 mg/mL
- Dosage form
- Ophthalmic suspension
- Route
- Ophthalmic
- Packs
- 1 bottle and 18 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaLupinIndiaAmneal Pharmaceuticals NYArmas PharmaceuticalsBausch & Lomb AmericasPadagisSentiss PharmaceuticalsNorthStar RxLLC
- Origin register
- US FDA, United States
- Storage
- DO NOT FREEZE. Store upright between 15°-25°C (59°-77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- S01BA14 Loteprednol etabonate
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 May 2021
- Identifiers
- RxCUI 311382DailyMed set ID 55ec893d-4955-4d2c-8b5b-84f462d23e02, 36cfd5b8-c892-44e1-aaed-fb32d7aeca7c, e8b50444-fd49-427e-9c1b-f75cb1b62bb6 +5NDC 0574-4135, 62756-232, 60219-1362 +5Application ANDA215204, ANDA212450, ANDA217484 +3
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 5 mL in 1 bottle | 70748-300-01 | LupinIndia | 15 July 2025 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 70748-300-02 | LupinIndia | 27 August 2025 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 62756-232-55 | Sun Pharmaceutical IndustriesIndia | 1 May 2021 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 62756-232-56 | Sun Pharmaceutical IndustriesIndia | 1 May 2021 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 62756-232-90 | Sun Pharmaceutical IndustriesIndia | 1 May 2021 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 60219-1362-1 | Amneal Pharmaceuticals NY | 22 May 2025 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 60219-1362-2 | Amneal Pharmaceuticals NY | 22 May 2025 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 60219-1362-3 | Amneal Pharmaceuticals NY | 22 May 2025 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 72485-665-05 | Armas Pharmaceuticals | 26 October 2023 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 72485-665-10 | Armas Pharmaceuticals | 26 October 2023 |
| 1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper | 72485-665-15 | Armas Pharmaceuticals | 26 October 2023 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 82260-299-05 | Bausch & Lomb Americas | 7 April 2023 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 82260-299-10 | Bausch & Lomb Americas | 7 April 2023 |
| 1 bottle in 1 carton / 15 mL in 1 bottle | 82260-299-15 | Bausch & Lomb Americas | 7 April 2023 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 0574-4135-05 | Padagis | 12 January 2026 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 0574-4135-10 | Padagis | 12 January 2026 |
| 1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper | 0574-4135-15 | Padagis | 12 January 2026 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 70244-034-01 | Sentiss Pharmaceuticals | 17 April 2026 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 70244-034-02 | Sentiss Pharmaceuticals | 17 April 2026 |
| 1 bottle, dropper in 1 carton / 15 mL in 1 bottle, dropper | 70244-034-03 | Sentiss Pharmaceuticals | 17 April 2026 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 72603-324-01 | NorthStar RxLLC | 1 September 2024 |
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 9 March 1998 | 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 Loteprednol etabonate 5 mg/mL ophthalmic suspension.
Other strengths and forms of Loteprednol etabonate
Clinical summary
Loteprednol etabonate is a corticosteroid indicated for the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, among other approved uses. MedsAcross supplies Loteprednol etabonate 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 Loteprednol etabonateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Loteprednol Etabonate prescribing information (Bausch & Lomb Americas) · U.S. National Library of Medicine, DailyMed
Need Loteprednol etabonate 5 mg/mL ophthalmic suspension 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.