Medicine
Diclofenac 1 mg/mL ophthalmic solution
Diclofenac 1 mg/mL ophthalmic solution is a generic prescription medicine for ophthalmic use, made by 3 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
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Diclofenac
- Brand
- Sold under the generic name
- Strength
- 1 mg/mL
- Dosage form
- Ophthalmic solution
- Route
- Ophthalmic
- Packs
- 1 bottle, 5 mL and 2 more
- Manufacturers
- Advagen PharmaSandozA-S Medication Solutions
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D11AX18 Diclofenac
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 February 2008
- Identifiers
- RxCUI 854801DailyMed set ID 52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b, 3a520306-fe3e-4830-963f-04b080db3abc, 72419a68-4c9d-44e0-9b43-922440e2c8d7NDC 61314-014, 50090-3568, 72888-150Application ANDA078031, ANDA077600
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 / 2.5 mL in 1 bottle | 72888-150-21 | Advagen Pharma | 30 April 2025 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 72888-150-22 | Advagen Pharma | 30 April 2025 |
| 1 bottle in 1 carton / 5 mL in 1 bottle | 61314-014-05 | Sandoz | 14 February 2018 |
| 1 bottle in 1 carton / 2.5 mL in 1 bottle | 61314-014-25 | Sandoz | 14 February 2018 |
| 5 mL in 1 bottle | 50090-3568-0 | A-S Medication Solutions | 31 August 2018 |
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 28 July 1988 | 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
Other strengths and forms of Diclofenac
Clinical summary
Diclofenac is a nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. MedsAcross supplies Diclofenac 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 DiclofenacFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ZIPSOR prescribing information (Assertio Specialty Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Diclofenac 1 mg/mL ophthalmic solution 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.