PAROXETINE

Orange BookUNIISPLATC N06AB05

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

Identification

ManufacturerMajor Pharmaceuticals

CountryUS (United States)

ATC codeN06AB05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0904567661
100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5676-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

3I3T11UD2S

PAROXETINE HYDROCHLORIDE ANHYDROUS

RxCUI 1311626

Orange Book

A075356

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "3I3T11UD2S",
    "rxcui": "1311626",
    "inchikey": "GELRVIPPMNMYGS-RVXRQPKJSA-N",
    "display_name": "PAROXETINE HYDROCHLORIDE ANHYDROUS",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "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": "0904-5676_9a171d3f-aa1b-4120-82ee-af67f33f167f",
  "productndc": "0904-5676",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075356",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Jul 30, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Jul 30, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "003",
        "approval_date": "Jul 30, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Jul 30, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAROXETINE HYDROCHLORIDE ANHYDROUS",
  "proprietary_name": "PAROXETINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075356",
  "marketing_category": "ANDA",
  "nonproprietary_name": "paroxetine hydrochloride",
  "start_marketing_date": "20030908",
  "active_numerator_strength": "10"
}

Related drugs

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