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United States · US · US:70518-0993_4849915c-b1ac-5f0c-e063-6394a90a16e4
PAROXETINE
Orange BookUNIISPLATC N06AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeN06AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117051809931100 POUCH in 1 BOX (70518-0993-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-0993-2)
Annotations
UNII (FDA Substance ID)
3I3T11UD2S
PAROXETINE HYDROCHLORIDE ANHYDROUS
RxCUI 1311626
Orange Book
A075356
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": "70518-0993_4849915c-b1ac-5f0c-e063-6394a90a16e4",
"productndc": "70518-0993",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "075356",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Jul 30, 2003"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Jul 30, 2003"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 30MG BASE",
"product_no": "003",
"approval_date": "Jul 30, 2003"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "004",
"approval_date": "Jul 30, 2003"
}
],
"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": "ANDA075356",
"marketing_category": "ANDA",
"nonproprietary_name": "paroxetine hydrochloride",
"start_marketing_date": "20180129",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code N06AB05.
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