Medicine
Diclofenac 1 mg/mL eye drops
Diclofenac 1 mg/mL eye drops 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).
Key facts
- Active ingredient (INN)
- Diclofenac
- Brand
- Sold under the generic name
- Strength
- 1 mg/mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle and 2 more
- Manufacturers
- Altaire PharmaceuticalsBausch & LombA-S Medication Solutions
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- 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
- 28 December 2007
- Identifiers
- RxCUI 854801DailyMed set ID 5372866a-dab3-45c8-8c2a-755ca36c1791, 5d74488c-e092-415d-b19b-05318380d9b1, 39dfffb0-612a-48f3-8db5-1a59899b91e9NDC 59390-149, 50090-2454, 24208-457Application ANDA203383, ANDA078792
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, dropper in 1 carton / 2.5 mL in 1 bottle, dropper | 59390-149-02 | Altaire Pharmaceuticals | 16 November 2015 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 59390-149-05 | Altaire Pharmaceuticals | 16 November 2015 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 24208-457-05 | Bausch & Lomb | 28 December 2007 |
| 1 bottle, dropper in 1 carton / 2.5 mL in 1 bottle, dropper | 24208-457-25 | Bausch & Lomb | 28 December 2007 |
| 1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper | 50090-2454-0 | A-S Medication Solutions | 12 August 2016 |
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 eye drops 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.