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United States · US · US:0574-0279_2da9c1a5-7b6c-4990-b6a5-1b06e1dd85cd

Paroxetine

Orange BookUNIISPLATC N06AB05

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPadagis US LLC
CountryUS (United States)
ATC codeN06AB05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0574027930
    30 CAPSULE in 1 BOTTLE (0574-0279-30)

Annotations

UNII (FDA Substance ID)
M711N184JE
PAROXETINE MESYLATE
RxCUI 436212
Orange Book
N204516
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "M711N184JE",
    "rxcui": "436212",
    "inchikey": "SHIJTGJXUHTGGZ-RVXRQPKJSA-N",
    "display_name": "PAROXETINE MESYLATE",
    "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": "0574-0279_2da9c1a5-7b6c-4990-b6a5-1b06e1dd85cd",
  "productndc": "0574-0279",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204516",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 7.5MG BASE",
        "product_no": "001",
        "approval_date": "Jun 28, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAROXETINE MESYLATE",
  "proprietary_name": "Paroxetine",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA204516",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "paroxetine",
  "start_marketing_date": "20171003",
  "active_numerator_strength": "7.5"
}

Related drugs

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