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United States · US · US:31722-578_5092043a-0e8c-05e1-e063-6394a90ad3dc

PAROXETINE HYDROCHLORIDE

Orange BookUNIISPLATC N06AB05

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN06AB05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3172257825
    1 BOTTLE in 1 CARTON (31722-578-25) / 250 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
X2ELS050D8
PAROXETINE HYDROCHLORIDE
RxCUI 1298842
Orange Book
A219954
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "X2ELS050D8",
    "rxcui": "1298842",
    "inchikey": "MQZOATSIFWSKKT-OASXIEIISA-N",
    "display_name": "PAROXETINE HYDROCHLORIDE",
    "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": "31722-578_5092043a-0e8c-05e1-e063-6394a90ad3dc",
  "productndc": "31722-578",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "219954",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Mar 5, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAROXETINE HYDROCHLORIDE",
  "proprietary_name": "PAROXETINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA219954",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PAROXETINE HYDROCHLORIDE",
  "start_marketing_date": "20260305",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N06AB05.

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