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United States · US · US:76420-850_21587ffd-a2a5-f093-e063-6394a90a6658

Hydroxychloroquine sulfate

In shortageOrange BookUNIISPLATC P01BA02

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

Identification

ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeP01BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7642085001
    100 TABLET, FILM COATED in 1 BOTTLE (76420-850-01)
  • ndc11
    7642085005
    500 TABLET, FILM COATED in 1 BOTTLE (76420-850-05)
  • ndc11
    7642085030
    30 TABLET, FILM COATED in 1 BOTTLE (76420-850-30)
  • ndc11
    7642085060
    60 TABLET, FILM COATED in 1 BOTTLE (76420-850-60)
  • ndc11
    7642085090
    90 TABLET, FILM COATED in 1 BOTTLE (76420-850-90)

Annotations

UNII (FDA Substance ID)
8Q2869CNVH
HYDROXYCHLOROQUINE SULFATE
RxCUI 153972
Orange Book
A040657
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": {
    "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": "76420-850_21587ffd-a2a5-f093-e063-6394a90a6658",
  "productndc": "76420-850",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "040657",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Sep 21, 2007"
      }
    ],
    "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": "ANDA040657",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydroxychloroquine sulfate",
  "start_marketing_date": "20191001",
  "active_numerator_strength": "200"
}

Related drugs

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