United States· US:68083-649_8c937f90-5ae8-49e9-808d-f3dbd9da1882
Alcaftadine
A alcaftadine product containing alcaftadine, registered in United States by Gland Pharma 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
- ALCAFTADINE
- Manufacturer
- Gland Pharma Limited
- Country
- United States (US)
- ATC code
- S01GX11
- ATC class
- Alcaftadine
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc1168083-649-01
- ndc1168083-649-02
- ndc1168083649011 BOTTLE in 1 CARTON (68083-649-01) / 3 mL in 1 BOTTLE
- ndc1168083649022 BOTTLE in 1 CARTON (68083-649-02) / 3 mL in 1 BOTTLE
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same class
Other records under S01GX11
Alcaftadine, as other registers publish it.
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/2e7a3f0e-b48c-4508-ab1e-e47cdd25706b GET /v1/drugs/2e7a3f0e-b48c-4508-ab1e-e47cdd25706b?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": "2.5",
"substance": "ALCAFTADINE",
"productndc": "68083-649",
"dosage_form": "SOLUTION/ DROPS",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "ANDA209706",
"marketing_category": "ANDA"
}See everything about alcaftadine.
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.