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United States · US · US:0615-7985_34c4cb21-d274-4d85-90f4-df09a9beffd8
Paroxetine
Orange BookUNIISPLATC N06AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
CountryUS (United States)
ATC codeN06AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11061579850515 TABLET, FILM COATED in 1 BLISTER PACK (0615-7985-05)
- ndc11061579853930 TABLET, FILM COATED in 1 BLISTER PACK (0615-7985-39)
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": "0615-7985_34c4cb21-d274-4d85-90f4-df09a9beffd8",
"productndc": "0615-7985",
"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": "20141101",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N06AB05.
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