Paroxetine

Orange BookSPL

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6586215601
100 TABLET, FILM COATED in 1 BOTTLE (65862-156-01)
ndc11
6586215605
500 TABLET, FILM COATED in 1 BOTTLE (65862-156-05)
ndc11
6586215630
30 TABLET, FILM COATED in 1 BOTTLE (65862-156-30)
ndc11
6586215690
90 TABLET, FILM COATED in 1 BOTTLE (65862-156-90)
ndc11
6586215699
1000 TABLET, FILM COATED in 1 BOTTLE (65862-156-99)

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": "65862-156_19f7a08f-58bd-45b8-a750-4432ae161455",
  "productndc": "65862-156",
  "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 Hydrochloride",
  "start_marketing_date": "20070725",
  "active_numerator_strength": "30"
}

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