Medicine
Sulfacetamide 100 mg/mL ophthalmic solution
Sulfacetamide 100 mg/mL ophthalmic solution is a generic prescription medicine for ophthalmic use, 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 between 8°-25°C (46°-77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Sulfacetamide
- Brand
- Sold under the generic name
- Strength
- 100 mg/mL
- Dosage form
- Ophthalmic solution
- Route
- Ophthalmic
- Packs
- 15 mL
- Manufacturer
- Asclemed
- Origin register
- US FDA, United States
- Storage
- Store between 8°-25°C (46°-77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D10AF06 Sulfacetamide
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 March 2003
- Identifiers
- RxCUI 1006120DailyMed set ID c4c29e13-8303-4a9a-bb47-d7413eaf2f26NDC 76420-076Application ANDA089560
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 |
|---|---|---|---|
| 15 mL in 1 bottle, plastic | 76420-076-15 | Asclemed | 16 January 2020 |
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 21 July 1946 | 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 Sulfacetamide
Clinical summary
Sulfacetamide is a sulfonamide antibacterial indicated in the topical treatment of acne vulgaris. It is available as eye drops, lotion and ophthalmic solution for topical use. MedsAcross supplies Sulfacetamide 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 SulfacetamideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Klaron prescribing information (Bausch Health) · U.S. National Library of Medicine, DailyMed
Need Sulfacetamide 100 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.