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United States · US · US:63187-564_4637d56c-fd38-47ea-b814-4d87a7d36f1f
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
- ndc11631875643030 TABLET, FILM COATED in 1 BOTTLE (63187-564-30)
- ndc11631875646060 TABLET, FILM COATED in 1 BOTTLE (63187-564-60)
- ndc11631875649090 TABLET, FILM COATED in 1 BOTTLE (63187-564-90)
Annotations
Orange Book
A078406
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": "63187-564_4637d56c-fd38-47ea-b814-4d87a7d36f1f",
"productndc": "63187-564",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078406",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Jul 25, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Jul 25, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 30MG BASE",
"product_no": "003",
"approval_date": "Jul 25, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "004",
"approval_date": "Jul 25, 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": "ANDA078406",
"marketing_category": "ANDA",
"nonproprietary_name": "Paroxetine",
"start_marketing_date": "20091203",
"active_numerator_strength": "20"
}Access this data programmatically
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