Paroxetine

Orange BookUNIISPLATC N06AB05

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN06AB05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6878887771
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8777-1)
ndc11
6878887773
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8777-3)
ndc11
6878887776
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8777-6)
ndc11
6878887778
120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8777-8)
ndc11
6878887779
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8777-9)

Annotations

UNII (FDA Substance ID)

X2ELS050D8

PAROXETINE HYDROCHLORIDE

RxCUI 1298842

Orange Book

A078902

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": "68788-8777_1a9c7947-4678-481e-b557-7ebf6dc04724",
  "productndc": "68788-8777",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078902",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Mar 13, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Mar 13, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "003",
        "approval_date": "Mar 13, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Mar 13, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAROXETINE HYDROCHLORIDE",
  "proprietary_name": "Paroxetine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078902",
  "marketing_category": "ANDA",
  "nonproprietary_name": "paroxetine hydrochloride hemihydrate",
  "start_marketing_date": "20250101",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code N06AB05.

Access this data programmatically

Query Paroxetine 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