United States· US:65145-207_2dc44fc5-b7fc-40ec-8e9b-d86fae1fc523
Gatifloxacin Ophthalmic Solution 0.5%
A medicinal product containing gatifloxacin anhydrous, registered in United States by Caplin Steriles Limited.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- GATIFLOXACIN ANHYDROUS
- Manufacturer
- Caplin Steriles Limited
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1165145-207-01
- ndc1165145207011 BOTTLE in 1 CARTON (65145-207-01) / 2.5 mL in 1 BOTTLE
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Gatifloxacin anhydrous in 3 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/d567fe8b-5550-4768-b913-bc92998005ab GET /v1/drugs/d567fe8b-5550-4768-b913-bc92998005ab?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "OPHTHALMIC",
"source": "ndc",
"strength": "5",
"substance": "GATIFLOXACIN ANHYDROUS",
"productndc": "65145-207",
"dosage_form": "SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "ANDA213542",
"marketing_category": "ANDA"
}See everything about gatifloxacin anhydrous.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.