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United States · US · US:59385-041_7ce44be3-47a7-411e-ad1f-a2efc4916425
SYMPROIC
Orange BookUNIISPLATC A06AH05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBioDelivery Sciences International Inc
CountryUS (United States)
ATC codeA06AH05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11593850413030 TABLET in 1 BOTTLE, PLASTIC (59385-041-30)
Annotations
UNII (FDA Substance ID)
V1N8F1RVVO
NALDEMEDINE TOSYLATE
RxCUI 1876598
Orange Book
N208854
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "V1N8F1RVVO",
"rxcui": "1876598",
"inchikey": "WCYDLROFMZJJLE-RTMHEQJQSA-N",
"display_name": "NALDEMEDINE TOSYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b1a1256c-a1eb-4abe-ab1e-30e4711afd16": {
"match": "brand_token",
"title": "SYMPROIC (NALDEMEDINE) TABLET [BIODELIVERY SCIENCES INTERNATIONAL INC]",
"spl_version": "10",
"published_date": "2025-07-31"
}
},
"productid": "59385-041_7ce44be3-47a7-411e-ad1f-a2efc4916425",
"productndc": "59385-041",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "208854",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.2MG BASE",
"product_no": "001",
"approval_date": "Mar 23, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NALDEMEDINE TOSYLATE",
"proprietary_name": "SYMPROIC",
"active_ingred_unit": "mg/1",
"application_number": "NDA208854",
"marketing_category": "NDA",
"nonproprietary_name": "naldemedine",
"start_marketing_date": "20190614",
"active_numerator_strength": ".2"
}Related drugs
Other records sharing ATC code A06AH05.
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