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United States· US:0527-0791_956b750f-3c89-4a24-9cf5-f65d04ed5c34

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

A medicinal product containing amphetamine aspartate monohydrate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate, registered in United States by Lannett Company, Inc..

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedDextroamphetamine Saccharate, Ampheta…ATC—REGISTER NO.US:0527-0791_956b750f…PACKS LISTED2CHECKEDJuly 12, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Manufacturer
Lannett Company, Inc.
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
July 12, 2026

Packs & prices · 2

  • ndc11
    0527-0791-37
  • ndc11
    0527079137
    100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-0791-37)

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/ef0d3d4a-dade-4a26-9fff-df4c79ee1e73
GET /v1/drugs/ef0d3d4a-dade-4a26-9fff-df4c79ee1e73?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": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
  "productndc": "0527-0791",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "dea_schedule": "CII",
  "strength_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "ANDA214403",
  "marketing_category": "ANDA"
}

See everything about amphetamine aspartate monohydrate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine 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.