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United States · US · US:83107-027_a33eb37f-c69b-41f3-9d18-540bfd226aa6
BRISDELLE
Orange BookUNIISPLATC N06AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLegacy Pharma USA, Inc.
CountryUS (United States)
ATC codeN06AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11831070273030 CAPSULE in 1 BLISTER PACK (83107-027-30)
Annotations
UNII (FDA Substance ID)
M711N184JE
PAROXETINE MESYLATE
RxCUI 436212
Orange Book
N204516
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "M711N184JE",
"rxcui": "436212",
"inchikey": "SHIJTGJXUHTGGZ-RVXRQPKJSA-N",
"display_name": "PAROXETINE MESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"502311b3-b617-4cbd-a3ab-a60f2c62880a": {
"match": "brand_token",
"title": "BRISDELLE (PAROXETINE) CAPSULE [LEGACY PHARMA USA, INC.]",
"spl_version": "2",
"published_date": "2025-05-05"
}
},
"productid": "83107-027_a33eb37f-c69b-41f3-9d18-540bfd226aa6",
"productndc": "83107-027",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "204516",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 7.5MG BASE",
"product_no": "001",
"approval_date": "Jun 28, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PAROXETINE MESYLATE",
"proprietary_name": "BRISDELLE",
"active_ingred_unit": "mg/1",
"application_number": "NDA204516",
"marketing_category": "NDA",
"nonproprietary_name": "paroxetine",
"start_marketing_date": "20250218",
"active_numerator_strength": "7.5"
}Related drugs
Other records sharing ATC code N06AB05.
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