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United States · US · US:54092-383_38ac432b-672e-4dd1-8af5-bea373aa5f3f

Adderall

In shortageOrange BookSPLATC N06BA

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

Identification

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

Packs · 1

  • ndc11
    5409238301
    100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-383-01)

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": {
    "aff45863-ffe1-4d4f-8acf-c7081512a6c0": {
      "match": "brand_token",
      "title": "ADDERALL XR (DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE) CAPSULE, EXTENDED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "38",
      "published_date": "2026-05-06"
    }
  },
  "productid": "54092-383_38ac432b-672e-4dd1-8af5-bea373aa5f3f",
  "productndc": "54092-383",
  "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": "Adderall",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "NDA021303",
  "marketing_category": "NDA",
  "nonproprietary_name": "Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate",
  "start_marketing_date": "20011011",
  "active_numerator_strength": "2.5; 2.5; 2.5; 2.5"
}

Related drugs

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