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United States · US · US:68788-8829_91c5a321-e174-4d86-9a84-e5e278d45aff
Paroxetine
Orange BookUNIISPLATC N06AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN06AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116878888291100 TABLET, FILM COATED in 1 BOTTLE (68788-8829-1)
- ndc11687888829330 TABLET, FILM COATED in 1 BOTTLE (68788-8829-3)
- ndc11687888829660 TABLET, FILM COATED in 1 BOTTLE (68788-8829-6)
- ndc116878888298120 TABLET, FILM COATED in 1 BOTTLE (68788-8829-8)
- ndc11687888829990 TABLET, FILM COATED in 1 BOTTLE (68788-8829-9)
Annotations
UNII (FDA Substance ID)
X2ELS050D8
PAROXETINE HYDROCHLORIDE
RxCUI 1298842
Orange Book
A203854
ABABABAB
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": "68788-8829_91c5a321-e174-4d86-9a84-e5e278d45aff",
"productndc": "68788-8829",
"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",
"proprietary_name": "Paroxetine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203854",
"marketing_category": "ANDA",
"nonproprietary_name": "paroxetine hydrochloride hemihydrate",
"start_marketing_date": "20250213",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N06AB05.
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