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United States · US · US:65841-098_ef5c1ef5-2884-4395-a65a-92591c986150
Paroxetine
Orange BookUNIISPLATC N06AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeN06AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116584109801100 TABLET, FILM COATED in 1 BOTTLE (65841-098-01)
- ndc116584109805500 TABLET, FILM COATED in 1 BOTTLE (65841-098-05)
- ndc11658410980630 TABLET, FILM COATED in 1 BOTTLE (65841-098-06)
- ndc1165841098101000 TABLET, FILM COATED in 1 BOTTLE (65841-098-10)
- ndc11658410981690 TABLET, FILM COATED in 1 BOTTLE (65841-098-16)
Annotations
UNII (FDA Substance ID)
3I3T11UD2S
PAROXETINE HYDROCHLORIDE ANHYDROUS
RxCUI 1311626
Orange Book
A077584
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "3I3T11UD2S",
"rxcui": "1311626",
"inchikey": "GELRVIPPMNMYGS-RVXRQPKJSA-N",
"display_name": "PAROXETINE HYDROCHLORIDE ANHYDROUS",
"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": "65841-098_ef5c1ef5-2884-4395-a65a-92591c986150",
"productndc": "65841-098",
"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 ANHYDROUS",
"proprietary_name": "Paroxetine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077584",
"marketing_category": "ANDA",
"nonproprietary_name": "Paroxetine Hydrochloride",
"start_marketing_date": "20070413",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code N06AB05.
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