United States· US:0378-7055_c8ce95fa-e800-433e-8d40-70a6b1e06140
Bepotastine Besilate
A medicinal product containing bepotastine besilate, registered in United States by Mylan Pharmaceuticals Inc..
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
- BEPOTASTINE BESILATE
- Manufacturer
- Mylan Pharmaceuticals Inc.
- 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 · 4
- ndc1103787055351 BOTTLE, DROPPER in 1 CARTON (0378-7055-35) / 5 mL in 1 BOTTLE, DROPPER
- ndc1103787055671 BOTTLE, DROPPER in 1 CARTON (0378-7055-67) / 10 mL in 1 BOTTLE, DROPPER
- ndc110378-7055-35
- ndc110378-7055-67
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Bepotastine besilate in 1 other country
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/e16292bb-9f33-4622-8670-cd6fa7aa9593 GET /v1/drugs/e16292bb-9f33-4622-8670-cd6fa7aa9593?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": "15",
"substance": "BEPOTASTINE BESILATE",
"productndc": "0378-7055",
"dosage_form": "SOLUTION/ DROPS",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "ANDA206220",
"marketing_category": "ANDA"
}See everything about bepotastine besilate.
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.