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United States · US · US:50090-6280_e3ddf397-4b8f-40cf-adbc-d1f056fc27a6

Hydroxychloroquine Sulfate

In shortageOrange BookUNIISPLATC P01BA02

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeP01BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5009062801
    60 TABLET in 1 BOTTLE (50090-6280-1)
  • ndc11
    5009062802
    90 TABLET in 1 BOTTLE (50090-6280-2)

Annotations

UNII (FDA Substance ID)
8Q2869CNVH
HYDROXYCHLOROQUINE SULFATE
RxCUI 153972
Orange Book
A213342
ABABABAB
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": {
    "6971241c-8323-456e-91a4-a404a9e100de": {
      "match": "brand_token",
      "title": "HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]",
      "spl_version": "16",
      "published_date": "2026-06-01"
    }
  },
  "productid": "50090-6280_e3ddf397-4b8f-40cf-adbc-d1f056fc27a6",
  "productndc": "50090-6280",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213342",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Apr 7, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Aug 18, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Aug 18, 2021"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "004",
        "approval_date": "Aug 18, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROXYCHLOROQUINE SULFATE",
  "shortage_reason": "Hydroxychloroquine Sulfate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Hydroxychloroquine Sulfate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213342",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydroxychloroquine Sulfate",
  "start_marketing_date": "20200512",
  "active_numerator_strength": "200"
}

Related drugs

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