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United States · US · US:71209-096_03756846-6e37-4c43-9a84-58e06801336a
Paroxetine
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCadila Pharmaceuticals Limited
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11712090960130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71209-096-01)
- ndc117120909610500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71209-096-10)
Annotations
Orange Book
A212645
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"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": "71209-096_03756846-6e37-4c43-9a84-58e06801336a",
"productndc": "71209-096",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "212645",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 12.5MG BASE",
"product_no": "001",
"approval_date": "Aug 27, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "002",
"approval_date": "Aug 27, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 37.5MG BASE",
"product_no": "003",
"approval_date": "Aug 27, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"proprietary_name": "Paroxetine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212645",
"marketing_category": "ANDA",
"nonproprietary_name": "Paroxetine",
"start_marketing_date": "20200214",
"active_numerator_strength": "37.5"
}Access this data programmatically
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