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United States · US · US:64850-502_b65e0266-7172-4730-8f93-eb42e08fb7b8

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

ManufacturerElite Laboratories, Inc.
CountryUS (United States)
ATC codeN06BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6485050201
    100 TABLET in 1 BOTTLE (64850-502-01)
  • ndc11
    6485050205
    500 TABLET in 1 BOTTLE (64850-502-05)
  • ndc11
    6485050230
    30 TABLET in 1 BOTTLE (64850-502-30)

Annotations

Orange Book
A211352
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": "64850-502_b65e0266-7172-4730-8f93-eb42e08fb7b8",
  "productndc": "64850-502",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211352",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.25MG;1.25MG;1.25MG;1.25MG",
        "product_no": "001",
        "approval_date": "Dec 7, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.875MG;1.875MG;1.875MG;1.875MG",
        "product_no": "002",
        "approval_date": "Dec 7, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG;2.5MG;2.5MG;2.5MG",
        "product_no": "003",
        "approval_date": "Dec 7, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3.125MG;3.125MG;3.125MG;3.125MG",
        "product_no": "004",
        "approval_date": "Dec 7, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3.75MG;3.75MG;3.75MG;3.75MG",
        "product_no": "005",
        "approval_date": "Dec 7, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG;5MG;5MG;5MG",
        "product_no": "006",
        "approval_date": "Dec 7, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG;7.5MG;7.5MG;7.5MG",
        "product_no": "007",
        "approval_date": "Dec 7, 2018"
      }
    ],
    "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": "ANDA211352",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate",
  "start_marketing_date": "20221229",
  "active_numerator_strength": "2.5; 2.5; 2.5; 2.5"
}

Related drugs

Other records sharing ATC code N06BA.

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