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United States · US · US:0115-9927_42b19d09-cffd-4772-bc84-76c2066d6f00
Dextroamphetamine Sulfate
Orange BookUNIISPLATC N06BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeN06BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11011599271090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-9927-10)
Annotations
UNII (FDA Substance ID)
JJ768O327N
DEXTROAMPHETAMINE SULFATE
RxCUI 3287
Orange Book
N017078
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "JJ768O327N",
"rxcui": "3287",
"inchikey": "PYHRZPFZZDCOPH-QXGOIDDHSA-N",
"display_name": "DEXTROAMPHETAMINE SULFATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"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": "0115-9927_42b19d09-cffd-4772-bc84-76c2066d6f00",
"productndc": "0115-9927",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "017078",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "15MG",
"product_no": "003",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXTROAMPHETAMINE SULFATE",
"proprietary_name": "Dextroamphetamine Sulfate",
"active_ingred_unit": "mg/1",
"application_number": "NDA017078",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Dextroamphetamine Sulfate",
"start_marketing_date": "19760802",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N06BA02.
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