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United States · US · US:0574-0279_2da9c1a5-7b6c-4990-b6a5-1b06e1dd85cd
Paroxetine
Orange BookUNIISPLATC N06AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis US LLC
CountryUS (United States)
ATC codeN06AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11057402793030 CAPSULE in 1 BOTTLE (0574-0279-30)
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": {
"e63fe922-b35a-406c-8737-f3f5e6d5a30d": {
"match": "brand_token",
"title": "PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "17",
"published_date": "2026-06-01"
}
},
"productid": "0574-0279_2da9c1a5-7b6c-4990-b6a5-1b06e1dd85cd",
"productndc": "0574-0279",
"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": "Paroxetine",
"active_ingred_unit": "mg/1",
"application_number": "NDA204516",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "paroxetine",
"start_marketing_date": "20171003",
"active_numerator_strength": "7.5"
}Related drugs
Other records sharing ATC code N06AB05.
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