Paroxetine

Orange BookUNIISPLATC N06AB05

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

Identification

ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs

CountryUS (United States)

ATC codeN06AB05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0615835939
30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8359-39)

Annotations

UNII (FDA Substance ID)

X2ELS050D8

PAROXETINE HYDROCHLORIDE

RxCUI 1298842

Orange Book

A078406

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": "0615-8359_d04ea3ee-ed50-48ca-8226-fb2d029053f3",
  "productndc": "0615-8359",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078406",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Jul 25, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Jul 25, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "003",
        "approval_date": "Jul 25, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Jul 25, 2007"
      }
    ],
    "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": "ANDA078406",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Paroxetine",
  "start_marketing_date": "20091203",
  "active_numerator_strength": "10"
}

Related drugs

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