paroxetine hydrochloride

Orange BookUNIISPLATC N06AB05

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerOxford Pharmaceuticals, LLC

CountryUS (United States)

ATC codeN06AB05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6958467203
30 TABLET, FILM COATED in 1 BOTTLE (69584-672-03)
ndc11
6958467209
90 TABLET, FILM COATED in 1 BOTTLE (69584-672-09)
ndc11
6958467210
100 TABLET, FILM COATED in 1 BOTTLE (69584-672-10)
ndc11
6958467250
500 TABLET, FILM COATED in 1 BOTTLE (69584-672-50)
ndc11
6958467290
1000 TABLET, FILM COATED in 1 BOTTLE (69584-672-90)

Annotations

UNII (FDA Substance ID)

X2ELS050D8

PAROXETINE HYDROCHLORIDE

RxCUI 1298842

Orange Book

A076968

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": "69584-672_2ac7f06f-af78-4705-a209-d9041b2de825",
  "productndc": "69584-672",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076968",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Jun 21, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Jun 21, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "003",
        "approval_date": "Jun 21, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Jun 21, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAROXETINE HYDROCHLORIDE",
  "proprietary_name": "paroxetine hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076968",
  "marketing_category": "ANDA",
  "nonproprietary_name": "paroxetine hydrochloride",
  "start_marketing_date": "20221114",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code N06AB05.

Access this data programmatically

Query paroxetine hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs