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United States · US · US:68788-7410_a3a3e9bd-930c-40be-acbb-95701c9a0fe2
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 · 6
- ndc116878874101100 TABLET, FILM COATED in 1 BOTTLE (68788-7410-1)
- ndc11687887410228 TABLET, FILM COATED in 1 BOTTLE (68788-7410-2)
- ndc11687887410330 TABLET, FILM COATED in 1 BOTTLE (68788-7410-3)
- ndc11687887410660 TABLET, FILM COATED in 1 BOTTLE (68788-7410-6)
- ndc116878874108120 TABLET, FILM COATED in 1 BOTTLE (68788-7410-8)
- ndc11687887410990 TABLET, FILM COATED in 1 BOTTLE (68788-7410-9)
Annotations
UNII (FDA Substance ID)
X2ELS050D8
PAROXETINE HYDROCHLORIDE
RxCUI 1298842
Orange Book
A077584
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": "68788-7410_a3a3e9bd-930c-40be-acbb-95701c9a0fe2",
"productndc": "68788-7410",
"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",
"proprietary_name": "Paroxetine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077584",
"marketing_category": "ANDA",
"nonproprietary_name": "Paroxetine",
"start_marketing_date": "20180606",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code N06AB05.
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