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United States · US · US:68180-647_1a9bc25c-db83-42a0-851a-30212ee10cc6
PAROXETINE
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
Orange Book
A204134
ABABAB
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": "68180-647_1a9bc25c-db83-42a0-851a-30212ee10cc6",
"productndc": "68180-647",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "204134",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 12.5MG BASE",
"product_no": "001",
"approval_date": "Jan 20, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "002",
"approval_date": "Jan 20, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 37.5MG BASE",
"product_no": "003",
"approval_date": "Jan 20, 2017"
}
],
"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": "ANDA204134",
"marketing_category": "ANDA",
"nonproprietary_name": "PAROXETINE",
"start_marketing_date": "20170306",
"active_numerator_strength": "12.5"
}Access this data programmatically
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