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United States · US · US:59212-562_1138fd4e-dfba-4c96-a5ec-60f8bc1ba746

Plaquenil

In shortageOrange BookUNIISPLATC P01BA02

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

Identification

ManufacturerAdvanz Pharma (US) Corp.
CountryUS (United States)
ATC codeP01BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5921256210
    100 TABLET in 1 BOTTLE (59212-562-10)
  • ndc11
    5921256211
    100 TABLET in 1 BOTTLE (59212-562-11)
  • ndc11
    5921256260
    60 TABLET in 1 BOTTLE (59212-562-60)

Annotations

UNII (FDA Substance ID)
8Q2869CNVH
HYDROXYCHLOROQUINE SULFATE
RxCUI 153972
Orange Book
N009768
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Hydroxychloroquine Sulfate Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "8Q2869CNVH",
    "rxcui": "153972",
    "inchikey": "JCBIVZZPXRZKTI-UHFFFAOYSA-N",
    "display_name": "HYDROXYCHLOROQUINE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "34496b43-05a2-45fb-a769-52b12e099341": {
      "match": "brand_token",
      "title": "PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLET [ADVANZ PHARMA (US) CORP.]",
      "spl_version": "15",
      "published_date": "2026-05-21"
    }
  },
  "productid": "59212-562_1138fd4e-dfba-4c96-a5ec-60f8bc1ba746",
  "productndc": "59212-562",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "009768",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROXYCHLOROQUINE SULFATE",
  "shortage_reason": "Hydroxychloroquine Sulfate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Plaquenil",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA009768",
  "marketing_category": "NDA",
  "nonproprietary_name": "Hydroxychloroquine Sulfate",
  "start_marketing_date": "20130628",
  "active_numerator_strength": "200"
}

Related drugs

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