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United States · US · US:62175-471_9474f942-d6d8-486b-8ea6-f8c561bb5014
Paroxetine Hydrochloride
Orange BookUNIISPLATC N06AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeN06AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11621754713230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-471-32)
- ndc116217547141500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-471-41)
Annotations
UNII (FDA Substance ID)
X2ELS050D8
PAROXETINE HYDROCHLORIDE
RxCUI 1298842
Orange Book
A204744
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": "62175-471_9474f942-d6d8-486b-8ea6-f8c561bb5014",
"productndc": "62175-471",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "204744",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 12.5MG BASE",
"product_no": "001",
"approval_date": "Jun 10, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "002",
"approval_date": "Jun 10, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 37.5MG BASE",
"product_no": "003",
"approval_date": "Jun 10, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PAROXETINE HYDROCHLORIDE",
"proprietary_name": "Paroxetine Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204744",
"marketing_category": "ANDA",
"nonproprietary_name": "Paroxetine Hydrochloride",
"start_marketing_date": "20141031",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N06AB05.
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