United States· US:35573-465_01fe666a-d04e-4dce-af71-8db45bbde653
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
A medicinal product containing dextroamphetamine saccharate; dextroamphetamine sulfate; amphetamine aspartate monohydrate; amphetamine sulfate, registered in United States by Burel Pharmaceuticals, LLC.
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
- DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE
- Manufacturer
- Burel Pharmaceuticals, LLC
- 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
- ndc113557346502100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-465-02)
- ndc1135573-465-02
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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/df49311e-9377-4bac-adf9-f45331fb891e GET /v1/drugs/df49311e-9377-4bac-adf9-f45331fb891e?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": "ORAL",
"source": "ndc",
"strength": "2.5; 2.5; 2.5; 2.5",
"substance": "DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE",
"productndc": "35573-465",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"dea_schedule": "CII",
"strength_unit": "mg/1; mg/1; mg/1; mg/1",
"application_number": "ANDA212037",
"marketing_category": "ANDA"
}See everything about dextroamphetamine saccharate; dextroamphetamine sulfate; amphetamine aspartate monohydrate; amphetamine sulfate.
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.