Paroxetine

Orange BookUNIISPLATC N06AB05

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

Identification

ManufacturerAmerican Health Packaging

CountryUS (United States)

ATC codeN06AB05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808404701
100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-047-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-047-11)

Annotations

UNII (FDA Substance ID)

X2ELS050D8

PAROXETINE HYDROCHLORIDE

RxCUI 1298842

Orange Book

A077584

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": "68084-047_51b97a0a-6710-bf64-e063-6294a90ae626",
  "productndc": "68084-047",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077584",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Mar 7, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Mar 7, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "003",
        "approval_date": "Mar 7, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Mar 7, 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": "ANDA077584",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Paroxetine",
  "start_marketing_date": "20050315",
  "active_numerator_strength": "40"
}

Related drugs

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