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United States · US · US:75826-125_37ddfa9e-e495-a25f-e063-6394a90ac3d9
Dextroamphetamine Sulfate
Orange BookUNIISPLATC N06BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWinder Laboratories LLC
CountryUS (United States)
ATC codeN06BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117582612510100 TABLET in 1 BOTTLE, PLASTIC (75826-125-10)
- ndc11758261253030 TABLET in 1 BOTTLE, PLASTIC (75826-125-30)
Annotations
UNII (FDA Substance ID)
JJ768O327N
DEXTROAMPHETAMINE SULFATE
RxCUI 3287
Orange Book
A212160
AAAAAAAAAAAAAA
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": "75826-125_37ddfa9e-e495-a25f-e063-6394a90ac3d9",
"productndc": "75826-125",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "212160",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Jun 7, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "5MG",
"product_no": "002",
"approval_date": "Jun 7, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "7.5MG",
"product_no": "003",
"approval_date": "Jun 7, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10MG",
"product_no": "004",
"approval_date": "Jun 7, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "15MG",
"product_no": "005",
"approval_date": "Jun 7, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "20MG",
"product_no": "006",
"approval_date": "Jun 7, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "30MG",
"product_no": "007",
"approval_date": "Jun 7, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXTROAMPHETAMINE SULFATE",
"proprietary_name": "Dextroamphetamine Sulfate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212160",
"marketing_category": "ANDA",
"nonproprietary_name": "Dextroamphetamine Sulfate",
"start_marketing_date": "20211206",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N06BA02.
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