Paroxetine

Orange BookSPL

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7642071601
100 TABLET, FILM COATED in 1 BOTTLE (76420-716-01)
ndc11
7642071605
500 TABLET, FILM COATED in 1 BOTTLE (76420-716-05)
ndc11
7642071610
1000 TABLET, FILM COATED in 1 BOTTLE (76420-716-10)
ndc11
7642071630
30 TABLET, FILM COATED in 1 BOTTLE (76420-716-30)
ndc11
7642071660
60 TABLET, FILM COATED in 1 BOTTLE (76420-716-60)
ndc11
7642071690
90 TABLET, FILM COATED in 1 BOTTLE (76420-716-90)

Annotations

Orange Book

A077584

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": "76420-716_2e000f86-0592-a362-e063-6394a90a169d",
  "productndc": "76420-716",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077584",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Mar 7, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Mar 7, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "003",
        "approval_date": "Mar 7, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Mar 7, 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": "ANDA077584",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Paroxetine",
  "start_marketing_date": "20070413",
  "active_numerator_strength": "10"
}

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