MYDAYIS

In shortageOrange BookSPLATC N06BA

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

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
5409246801
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-468-01)

Annotations

Orange Book

N022063

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": {
    "141a7970-3f06-44ea-9ab7-aeece2c085fc": {
      "match": "brand_token",
      "title": "MYDAYIS (DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, AND AMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "13",
      "published_date": "2026-05-06"
    }
  },
  "productid": "54092-468_13a2ab7d-af84-4e46-a58f-9e9c17b5c0e5",
  "productndc": "54092-468",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "022063",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "3.125MG;3.125MG;3.125MG;3.125MG",
        "product_no": "001",
        "approval_date": "Jun 20, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "6.25MG;6.25MG;6.25MG;6.25MG",
        "product_no": "002",
        "approval_date": "Jun 20, 2017"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "9.375MG;9.375MG;9.375MG;9.375MG",
        "product_no": "003",
        "approval_date": "Jun 20, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB2",
        "strength": "12.5MG;12.5MG;12.5MG;12.5MG",
        "product_no": "004",
        "approval_date": "Jun 20, 2017"
      }
    ],
    "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": "MYDAYIS",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "NDA022063",
  "marketing_category": "NDA",
  "nonproprietary_name": "DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE",
  "start_marketing_date": "20170620",
  "active_numerator_strength": "3.125; 3.125; 3.125; 3.125"
}

Related drugs

Other records sharing ATC code N06BA.

Access this data programmatically

Query MYDAYIS and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs