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United States · US · US:43598-133_45c22bbf-6332-4f7f-b77e-8ac613435821

HYDROXYCHLOROQUINE SULFATE

In shortageOrange BookUNIISPLATC P01BA02

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

Identification

ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC codeP01BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4359813301
    100 TABLET, FILM COATED in 1 BOTTLE (43598-133-01)
  • ndc11
    4359813305
    500 TABLET, FILM COATED in 1 BOTTLE (43598-133-05)

Annotations

UNII (FDA Substance ID)
8Q2869CNVH
HYDROXYCHLOROQUINE SULFATE
RxCUI 153972
Orange Book
A210441
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": "43598-133_45c22bbf-6332-4f7f-b77e-8ac613435821",
  "productndc": "43598-133",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210441",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "May 1, 2018"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Sep 19, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Sep 19, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "004",
        "approval_date": "Sep 19, 2022"
      }
    ],
    "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": "ANDA210441",
  "marketing_category": "ANDA",
  "nonproprietary_name": "HYDROXYCHLOROQUINE SULFATE",
  "start_marketing_date": "20221024",
  "active_numerator_strength": "100"
}

Related drugs

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