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United States · US · US:54092-385_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
- ndc115409238501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-385-01)
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": "54092-385_38ac432b-672e-4dd1-8af5-bea373aa5f3f",
"productndc": "54092-385",
"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": "20020522",
"active_numerator_strength": "3.75; 3.75; 3.75; 3.75"
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