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United States· US:0185-0853_9a21fb59-a99c-4c63-91e8-4b5d72fbd9cd

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

A medicinal product containing dextroamphetamine saccharate; amphetamine aspartate monohydrate; dextroamphetamine sulfate; amphetamine sulfate, registered in United States by Sandoz 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:0185-0853_9a21fb59…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
Manufacturer
Sandoz 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

  • ndc11
    0185085301
    100 TABLET in 1 BOTTLE (0185-0853-01)
  • ndc11
    0185-0853-01

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/c52c1760-d012-42ae-b583-b2f7f5c1224e
GET /v1/drugs/c52c1760-d012-42ae-b583-b2f7f5c1224e?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": "5; 5; 5; 5",
  "substance": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
  "productndc": "0185-0853",
  "dosage_form": "TABLET",
  "dea_schedule": "CII",
  "strength_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "ANDA040439",
  "marketing_category": "ANDA"
}

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