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United States · US · US:83980-001_31f4188d-1c26-4aab-aa12-354329160a39

Hydroxychloroquine Sulfate

In shortageOrange BookUNIISPLATC P01BA02

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

Identification

ManufacturerIpca Laboratories Limited
CountryUS (United States)
ATC codeP01BA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    8398000101
    100 TABLET, FILM COATED in 1 BOTTLE (83980-001-01)
  • ndc11
    8398000105
    500 TABLET, FILM COATED in 1 BOTTLE (83980-001-05)
  • ndc11
    8398000110
    1000 TABLET, FILM COATED in 1 BOTTLE (83980-001-10)
  • ndc11
    8398000197
    10 TABLET, FILM COATED in 1 BOTTLE (83980-001-97)

Annotations

UNII (FDA Substance ID)
8Q2869CNVH
HYDROXYCHLOROQUINE SULFATE
RxCUI 153972
Orange Book
A040766
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": "83980-001_31f4188d-1c26-4aab-aa12-354329160a39",
  "productndc": "83980-001",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "040766",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Jun 14, 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": "ANDA040766",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydroxychloroquine Sulfate",
  "start_marketing_date": "20240603",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code P01BA02.

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