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United States · US · US:60505-4520_62b4ffe1-48e2-6dd5-d7ca-28e8efe36686
PAXIL
Orange BookUNIISPLATC N06AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp
CountryUS (United States)
ATC codeN06AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11605054520330 TABLET, FILM COATED in 1 BOTTLE (60505-4520-3)
Annotations
UNII (FDA Substance ID)
X2ELS050D8
PAROXETINE HYDROCHLORIDE
RxCUI 1298842
Orange Book
N020031
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "X2ELS050D8",
"rxcui": "1298842",
"inchikey": "MQZOATSIFWSKKT-OASXIEIISA-N",
"display_name": "PAROXETINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"483bd97f-c4d0-4e23-aaa8-6334f4471e0c": {
"match": "brand_token",
"title": "PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]",
"spl_version": "32",
"published_date": "2025-09-25"
}
},
"productid": "60505-4520_62b4ffe1-48e2-6dd5-d7ca-28e8efe36686",
"productndc": "60505-4520",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "020031",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Dec 29, 1992"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Dec 29, 1992"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 30MG BASE",
"product_no": "003",
"approval_date": "Dec 29, 1992"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 50MG BASE",
"product_no": "004",
"approval_date": "Dec 29, 1992"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "005",
"approval_date": "Dec 29, 1992"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PAROXETINE HYDROCHLORIDE",
"proprietary_name": "PAXIL",
"active_ingred_unit": "mg/1",
"application_number": "NDA020031",
"marketing_category": "NDA",
"nonproprietary_name": "paroxetine hydrochloride",
"start_marketing_date": "20190311",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code N06AB05.
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