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

In shortageOrange BookSPLATC N06BA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSandoz Inc

CountryUS (United States)

ATC codeN06BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0781234301
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2343-01)

Annotations

Orange Book

N021303

AB1AB1AB1AB1AB1AB1

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

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

Raw payload (JSON)

{
  "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": "0781-2343_11936c1c-41a8-481c-b12f-dcc5837968d2",
  "productndc": "0781-2343",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021303",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "2.5MG;2.5MG;2.5MG;2.5MG",
        "product_no": "001",
        "approval_date": "Oct 11, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "5MG;5MG;5MG;5MG",
        "product_no": "002",
        "approval_date": "Oct 11, 2001"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB1",
        "strength": "7.5MG;7.5MG;7.5MG;7.5MG",
        "product_no": "003",
        "approval_date": "Oct 11, 2001"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "6.25MG;6.25MG;6.25MG;6.25MG",
        "product_no": "004",
        "approval_date": "May 22, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "1.25MG;1.25MG;1.25MG;1.25MG",
        "product_no": "005",
        "approval_date": "May 22, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "3.75MG;3.75MG;3.75MG;3.75MG",
        "product_no": "006",
        "approval_date": "May 22, 2002"
      }
    ],
    "appl_type": "N"
  },
  "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, Dextroamphetamine Sulfate, and Amphetamine Sulfate",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "NDA021303",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE",
  "start_marketing_date": "20090402",
  "active_numerator_strength": "3.75; 3.75; 3.75; 3.75"
}

Related drugs

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