United States· US:64850-512_2754568b-2953-465f-b872-77ab3a793d54

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

A centrally acting sympathomimetics product containing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, registered in United States by Elite Laboratories, Inc..

In shortageATC N06BAOrange BookUS label

Checked against FDA National Drug Code directory (United States) on June 3, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
Manufacturer: Elite Laboratories, Inc.
Country: United States (US)
ATC code: N06BA
ATC class: Centrally acting sympathomimetics
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: June 3, 2026

Packs & prices · 1

ndc11
6485051201
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (64850-512-01)

Regulatory notes

Orange Book

A212037

AB1AB1AB1AB1AB1AB1

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet

Same class

Other records under N06BA

Centrally acting sympathomimetics, as other registers publish it.

All dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate products

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/5bae8822-2f3f-4bc0-b667-00109ea4c085
GET /v1/drugs/5bae8822-2f3f-4bc0-b667-00109ea4c085?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",
  "spl_meta": {
    "f6dfefdf-7a4a-e104-e053-6394a90a05bd": {
      "match": "brand_token",
      "title": "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE) CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "7",
      "published_date": "2026-06-01"
    }
  },
  "productid": "64850-512_2754568b-2953-465f-b872-77ab3a793d54",
  "productndc": "64850-512",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "212037",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "1.25MG;1.25MG;1.25MG;1.25MG",
        "product_no": "001",
        "approval_date": "Dec 11, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "2.5MG;2.5MG;2.5MG;2.5MG",
        "product_no": "002",
        "approval_date": "Dec 11, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "3.75MG;3.75MG;3.75MG;3.75MG",
        "product_no": "003",
        "approval_date": "Dec 11, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "5MG;5MG;5MG;5MG",
        "product_no": "004",
        "approval_date": "Dec 11, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "6.25MG;6.25MG;6.25MG;6.25MG",
        "product_no": "005",
        "approval_date": "Dec 11, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "7.5MG;7.5MG;7.5MG;7.5MG",
        "product_no": "006",
        "approval_date": "Dec 11, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
  "shortage_reason": "Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "ANDA212037",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate",
  "start_marketing_date": "20191216",
  "active_numerator_strength": "3.75; 3.75; 3.75; 3.75"
}

API reference MCP server Plans

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