Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate

In shortageOrange BookSPLATC N06BA

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeN06BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5766495388
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (57664-953-88)

Annotations

Orange Book

A215997

AB2AB2AB2AB2

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": "57664-953_10af8563-97ec-8a5e-e063-6394a90a52f8",
  "productndc": "57664-953",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "215997",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "3.125MG;3.125MG;3.125MG;3.125MG",
        "product_no": "001",
        "approval_date": "Sep 27, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "6.25MG;6.25MG;6.25MG;6.25MG",
        "product_no": "002",
        "approval_date": "Sep 27, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "9.375MG;9.375MG;9.375MG;9.375MG",
        "product_no": "003",
        "approval_date": "Sep 27, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "12.5MG;12.5MG;12.5MG;12.5MG",
        "product_no": "004",
        "approval_date": "Sep 27, 2023"
      }
    ],
    "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, amphetamine sulfate",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "ANDA215997",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate",
  "start_marketing_date": "20240201",
  "active_numerator_strength": "12.5; 12.5; 12.5; 12.5"
}

Related drugs

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