PAXIL

Orange BookUNIISPLATC N06AB05

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

Identification

ManufacturerApotex Corp

CountryUS (United States)

ATC codeN06AB05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6050545193
30 TABLET, FILM COATED in 1 BOTTLE (60505-4519-3)

Annotations

UNII (FDA Substance ID)

X2ELS050D8

PAROXETINE HYDROCHLORIDE

RxCUI 1298842

Orange Book

N020031

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": {
    "483bd97f-c4d0-4e23-aaa8-6334f4471e0c": {
      "match": "brand_token",
      "title": "PAXIL CR (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APOTEX CORP]",
      "spl_version": "32",
      "published_date": "2025-09-25"
    }
  },
  "productid": "60505-4519_62b4ffe1-48e2-6dd5-d7ca-28e8efe36686",
  "productndc": "60505-4519",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020031",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Dec 29, 1992"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Dec 29, 1992"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "003",
        "approval_date": "Dec 29, 1992"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 50MG BASE",
        "product_no": "004",
        "approval_date": "Dec 29, 1992"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "005",
        "approval_date": "Dec 29, 1992"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAROXETINE HYDROCHLORIDE",
  "proprietary_name": "PAXIL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020031",
  "marketing_category": "NDA",
  "nonproprietary_name": "paroxetine hydrochloride",
  "start_marketing_date": "20190311",
  "active_numerator_strength": "30"
}

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