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United States · US · US:72241-030_1d6895c1-d0ec-48f1-ad90-5c16d582a049
Paroxetine
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerModavar Pharmaceuticals LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117224103010500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72241-030-10)
- ndc11722410302230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72241-030-22)
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": "72241-030_1d6895c1-d0ec-48f1-ad90-5c16d582a049",
"productndc": "72241-030",
"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": "20211020",
"active_numerator_strength": "25"
}Access this data programmatically
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