Paroxetine

Orange BookSPL

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

Identification

ManufacturerAurolife Pharma LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
1310715501
100 TABLET, FILM COATED in 1 BOTTLE (13107-155-01)
ndc11
1310715505
500 TABLET, FILM COATED in 1 BOTTLE (13107-155-05)
ndc11
1310715530
30 TABLET, FILM COATED in 1 BOTTLE (13107-155-30)
ndc11
1310715590
90 TABLET, FILM COATED in 1 BOTTLE (13107-155-90)
ndc11
1310715599
1000 TABLET, FILM COATED in 1 BOTTLE (13107-155-99)

Annotations

Orange Book

A078406

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": "13107-155_c399d3cd-13a5-4493-9a93-c4bf5e2532fc",
  "productndc": "13107-155",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078406",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Jul 25, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Jul 25, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "003",
        "approval_date": "Jul 25, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Jul 25, 2007"
      }
    ],
    "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": "ANDA078406",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Paroxetine",
  "start_marketing_date": "20091203",
  "active_numerator_strength": "20"
}

Access this data programmatically

Query Paroxetine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs