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United States · US · US:71390-125_b4cf2d39-67e7-459b-add4-5454b1029c14
Barhemsys
Orange BookUNIISPLATC N05AL05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAcacia Pharma Ltd
CountryUS (United States)
ATC codeN05AL05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11713901252010 CARTON in 1 PACKAGE (71390-125-20) / 1 VIAL, SINGLE-DOSE in 1 CARTON (71390-125-21) / 2 mL in 1 VIAL, SINGLE-DOSE
- ndc11713901255010 CARTON in 1 PACKAGE (71390-125-50) / 1 VIAL, SINGLE-DOSE in 1 CARTON (71390-125-51) / 4 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
8110R61I4U
AMISULPRIDE
RxCUI 46303
Orange Book
N209510
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8110R61I4U",
"rxcui": "46303",
"inchikey": "NTJOBXMMWNYJFB-UHFFFAOYSA-N",
"display_name": "AMISULPRIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"ab23bc6e-b6a8-165f-e053-2a95a90ab144": {
"match": "brand_token",
"title": "BARHEMSYS (AMISULPRIDE) INJECTION, SOLUTION [ACACIA PHARMA LTD]",
"spl_version": "7",
"published_date": "2025-06-11"
}
},
"productid": "71390-125_b4cf2d39-67e7-459b-add4-5454b1029c14",
"productndc": "71390-125",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "209510",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5MG/2ML (2.5MG/ML)",
"product_no": "001",
"approval_date": "Feb 26, 2020"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG/4ML (2.5MG/ML)",
"product_no": "002",
"approval_date": "Sep 1, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMISULPRIDE",
"proprietary_name": "Barhemsys",
"active_ingred_unit": "mg/mL",
"application_number": "NDA209510",
"marketing_category": "NDA",
"nonproprietary_name": "Amisulpride",
"start_marketing_date": "20200227",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code N05AL05.
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