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United States · US · US:42858-703_9182de9d-25d0-4d69-b59a-af086213cd4f
PAROXETINE
Orange BookUNIISPLATC N06AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRhodes Pharmaceuticals LLC
CountryUS (United States)
ATC codeN06AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11428587030330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-703-03)
- ndc114285870350500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-703-50)
Annotations
UNII (FDA Substance ID)
X2ELS050D8
PAROXETINE HYDROCHLORIDE
RxCUI 1298842
Orange Book
A209293
ABABAB
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": {
"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": "42858-703_9182de9d-25d0-4d69-b59a-af086213cd4f",
"productndc": "42858-703",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "209293",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 12.5MG BASE",
"product_no": "001",
"approval_date": "Jun 12, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "002",
"approval_date": "Jun 12, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 37.5MG BASE",
"product_no": "003",
"approval_date": "Jun 12, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PAROXETINE HYDROCHLORIDE",
"proprietary_name": "PAROXETINE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209293",
"marketing_category": "ANDA",
"nonproprietary_name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"start_marketing_date": "20180914",
"active_numerator_strength": "12.5"
}Related drugs
Other records sharing ATC code N06AB05.
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