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United States · US · US:43547-409_30b0c2b9-fb81-4015-ad28-12e658de0dea

PAROXETINE

Orange BookUNIISPLATC N06AB05

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

Identification

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

Packs · 1

  • ndc11
    4354740903
    30 CAPSULE in 1 BOTTLE (43547-409-03)

Annotations

UNII (FDA Substance ID)
M711N184JE
PAROXETINE MESYLATE
RxCUI 436212
Orange Book
A207188
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": "43547-409_30b0c2b9-fb81-4015-ad28-12e658de0dea",
  "productndc": "43547-409",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "207188",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 7.5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 18, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAROXETINE MESYLATE",
  "proprietary_name": "PAROXETINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207188",
  "marketing_category": "ANDA",
  "nonproprietary_name": "paroxetine",
  "start_marketing_date": "20170815",
  "active_numerator_strength": "7.5"
}

Related drugs

Other records sharing ATC code N06AB05.

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