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United States · US · US:63187-434_b0100eac-f51f-4aa9-88e1-f628aeea2412
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
- ndc11631874343030 TABLET, FILM COATED in 1 BOTTLE (63187-434-30)
- ndc11631874346060 TABLET, FILM COATED in 1 BOTTLE (63187-434-60)
- ndc11631874349090 TABLET, FILM COATED in 1 BOTTLE (63187-434-90)
Annotations
Orange Book
A077584
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": "63187-434_b0100eac-f51f-4aa9-88e1-f628aeea2412",
"productndc": "63187-434",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "077584",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Mar 7, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Mar 7, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 30MG BASE",
"product_no": "003",
"approval_date": "Mar 7, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "004",
"approval_date": "Mar 7, 2007"
}
],
"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": "ANDA077584",
"marketing_category": "ANDA",
"nonproprietary_name": "Paroxetine",
"start_marketing_date": "20070413",
"active_numerator_strength": "40"
}Access this data programmatically
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