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United States · US · US:21724-701_06b4c32e-1880-40e9-9de2-0927cb8c1500
PROCENTRA
Orange BookUNIISPLATC N06BA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerINDEPENDENCE PHARMACEUTICALS, LLC
CountryUS (United States)
ATC codeN06BA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc112172470105473 mL in 1 BOTTLE, PLASTIC (21724-701-05)
Annotations
UNII (FDA Substance ID)
JJ768O327N
DEXTROAMPHETAMINE SULFATE
RxCUI 3287
Orange Book
A040776
AA
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": {
"1548cce2-fb6b-4f17-8a3b-868933f6c9d6": {
"match": "brand_token",
"title": "PROCENTRA (DEXTROAMPHETAMINE SULFATE) SOLUTION [INDEPENDENCE PHARMACEUTICALS, LLC]",
"spl_version": "17",
"published_date": "2025-11-17"
}
},
"productid": "21724-701_06b4c32e-1880-40e9-9de2-0927cb8c1500",
"productndc": "21724-701",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "040776",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "Jan 29, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": "CII",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXTROAMPHETAMINE SULFATE",
"proprietary_name": "PROCENTRA",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA040776",
"marketing_category": "ANDA",
"nonproprietary_name": "dextroamphetamine sulfate",
"start_marketing_date": "20140515",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N06BA02.
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