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United States · US · US:63187-927_b4618a70-5719-43c4-9010-ef790f7495cb
Paroxetine
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11631879273030 TABLET, FILM COATED in 1 BOTTLE (63187-927-30)
- ndc11631879276060 TABLET, FILM COATED in 1 BOTTLE (63187-927-60)
- ndc11631879279090 TABLET, FILM COATED in 1 BOTTLE (63187-927-90)
Annotations
Orange Book
A203854
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"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": "63187-927_b4618a70-5719-43c4-9010-ef790f7495cb",
"productndc": "63187-927",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "203854",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Oct 31, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Oct 31, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 30MG BASE",
"product_no": "003",
"approval_date": "Oct 31, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "004",
"approval_date": "Oct 31, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"proprietary_name": "Paroxetine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203854",
"marketing_category": "ANDA",
"nonproprietary_name": "paroxetine hydrochloride hemihydrate",
"start_marketing_date": "20141101",
"active_numerator_strength": "20"
}Access this data programmatically
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