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United States · US · US:13107-071_5962d880-9f18-4a57-8c95-ca0ec1e86f44

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

In shortageOrange BookSPLATC N06BA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAurolife Pharma, LLC
CountryUS (United States)
ATC codeN06BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    1310707101
    100 TABLET in 1 BOTTLE (13107-071-01)
  • ndc11
    1310707105
    500 TABLET in 1 BOTTLE (13107-071-05)
  • ndc11
    1310707125
    250 TABLET in 1 BOTTLE (13107-071-25)
  • ndc11
    1310707150
    50 TABLET in 1 BOTTLE (13107-071-50)
  • ndc11
    1310707199
    1000 TABLET in 1 BOTTLE (13107-071-99)

Annotations

Orange Book
A202424
ABABABABABABAB
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": "13107-071_5962d880-9f18-4a57-8c95-ca0ec1e86f44",
  "productndc": "13107-071",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202424",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.25MG;1.25MG;1.25MG;1.25MG",
        "product_no": "001",
        "approval_date": "Nov 27, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.875MG;1.875MG;1.875MG;1.875MG",
        "product_no": "002",
        "approval_date": "Nov 27, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;2.5MG;2.5MG;2.5MG",
        "product_no": "003",
        "approval_date": "Nov 27, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3.125MG;3.125MG;3.125MG;3.125MG",
        "product_no": "004",
        "approval_date": "Nov 27, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3.75MG;3.75MG;3.75MG;3.75MG",
        "product_no": "005",
        "approval_date": "Nov 27, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;5MG;5MG;5MG",
        "product_no": "006",
        "approval_date": "Nov 27, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG;7.5MG;7.5MG;7.5MG",
        "product_no": "007",
        "approval_date": "Nov 27, 2013"
      }
    ],
    "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, Dextroamphetamine Sulfate and Amphetamine Sulfate",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "ANDA202424",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate",
  "start_marketing_date": "20131127",
  "active_numerator_strength": "3.125; 3.125; 3.125; 3.125"
}

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