Paroxetine

Orange BookSPL

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4335354415
15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-15)
ndc11
4335354430
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-30)
ndc11
4335354445
45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-45)
ndc11
4335354460
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-544-60)

Annotations

Orange Book

A078902

ABABABAB

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": "43353-544_37d67ac2-1470-43aa-a06d-b24981539fd4",
  "productndc": "43353-544",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078902",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Mar 13, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Mar 13, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "003",
        "approval_date": "Mar 13, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Mar 13, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
  "proprietary_name": "Paroxetine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078902",
  "marketing_category": "ANDA",
  "nonproprietary_name": "paroxetine hydrochloride hemihydrate",
  "start_marketing_date": "20080324",
  "active_numerator_strength": "40"
}

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