Paroxetine

Orange BookUNIISPLATC N06AB05

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeN06AB05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009059870
90 TABLET, FILM COATED in 1 BOTTLE (50090-5987-0)

Annotations

UNII (FDA Substance ID)

3I3T11UD2S

PAROXETINE HYDROCHLORIDE ANHYDROUS

RxCUI 1311626

Orange Book

A203854

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "3I3T11UD2S",
    "rxcui": "1311626",
    "inchikey": "GELRVIPPMNMYGS-RVXRQPKJSA-N",
    "display_name": "PAROXETINE HYDROCHLORIDE ANHYDROUS",
    "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": "50090-5987_3e8cfd15-4821-46d2-ae90-827bb859f71a",
  "productndc": "50090-5987",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203854",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Oct 31, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Oct 31, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "003",
        "approval_date": "Oct 31, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Oct 31, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAROXETINE HYDROCHLORIDE ANHYDROUS",
  "proprietary_name": "Paroxetine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203854",
  "marketing_category": "ANDA",
  "nonproprietary_name": "paroxetine hydrochloride hemihydrate",
  "start_marketing_date": "20141101",
  "active_numerator_strength": "30"
}

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