United States· US:68382-860_c4849b63-a84f-4cf0-b937-7ca4b33f2d25
Benztropine Mesylate
A medicinal product containing benztropine mesylate, registered in United States by Zydus Pharmaceuticals USA 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
- BENZTROPINE MESYLATE
- Manufacturer
- Zydus Pharmaceuticals USA 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 · 2
- ndc1168382-860-10
- ndc1168382860105 VIAL in 1 CARTON (68382-860-10) / 2 mL in 1 VIAL (68382-860-02)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Benztropine mesylate 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/d6411e9b-3eff-42ee-99e4-ac6a09bb0d6e GET /v1/drugs/d6411e9b-3eff-42ee-99e4-ac6a09bb0d6e?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": "INTRAMUSCULAR; INTRAVENOUS",
"source": "ndc",
"strength": "1",
"substance": "BENZTROPINE MESYLATE",
"productndc": "68382-860",
"dosage_form": "INJECTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "ANDA091525",
"marketing_category": "ANDA"
}See everything about benztropine mesylate.
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.