Paroxetine Hydrochloride

Orange BookSPL

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6362985271
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-8527-1)

Annotations

Orange Book

A204744

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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": "63629-8527_d72b03fa-f81e-4eab-95aa-00c6c48ebf37",
  "productndc": "63629-8527",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "204744",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12.5MG BASE",
        "product_no": "001",
        "approval_date": "Jun 10, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "002",
        "approval_date": "Jun 10, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 37.5MG BASE",
        "product_no": "003",
        "approval_date": "Jun 10, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
  "proprietary_name": "Paroxetine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204744",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Paroxetine Hydrochloride",
  "start_marketing_date": "20141031",
  "active_numerator_strength": "25"
}

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