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United States · US · US:71205-448_8aec894d-5711-4079-b167-240713bf04f2

Plaquenil

In shortageOrange BookUNIISPLATC P01BA02

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeP01BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7120544812
    12 TABLET in 1 BOTTLE (71205-448-12)

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": "71205-448_8aec894d-5711-4079-b167-240713bf04f2",
  "productndc": "71205-448",
  "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"
}

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