paroxetine hydrochloride

Orange BookSPL

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7133596501
30 TABLET, FILM COATED in 1 BOTTLE (71335-9650-1)
ndc11
7133596502
60 TABLET, FILM COATED in 1 BOTTLE (71335-9650-2)
ndc11
7133596503
90 TABLET, FILM COATED in 1 BOTTLE (71335-9650-3)
ndc11
7133596504
180 TABLET, FILM COATED in 1 BOTTLE (71335-9650-4)

Annotations

Orange Book

A076968

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": "71335-9650_52e74299-f193-408d-9d0d-e48398a1734a",
  "productndc": "71335-9650",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076968",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Jun 21, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Jun 21, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 30MG BASE",
        "product_no": "003",
        "approval_date": "Jun 21, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Jun 21, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
  "proprietary_name": "paroxetine hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076968",
  "marketing_category": "ANDA",
  "nonproprietary_name": "paroxetine hydrochloride",
  "start_marketing_date": "20221114",
  "active_numerator_strength": "30"
}

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