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United States · US · US:64896-675_d5d5a976-872f-4849-b222-1fb433511511
DEXEDRINE
Orange BookUNIISPLATC N06BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeN06BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1164896675101 BOTTLE in 1 CARTON (64896-675-10) / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
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": {
"cc717b9b-22ea-4c60-a1d4-ee38a40bce78": {
"match": "brand_token",
"title": "DEXEDRINE SPANSULE (DEXTROAMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]",
"spl_version": "15",
"published_date": "2025-09-29"
}
},
"productid": "64896-675_d5d5a976-872f-4849-b222-1fb433511511",
"productndc": "64896-675",
"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": "DEXEDRINE",
"active_ingred_unit": "mg/1",
"application_number": "NDA017078",
"marketing_category": "NDA",
"nonproprietary_name": "dextroamphetamine sulfate",
"start_marketing_date": "19760802",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code N06BA02.
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