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United States · US · US:0093-2401_0c6c28a5-e86f-4643-bb22-f7eb5b1f440d

Hydroxychloroquine Sulfate

In shortageOrange BookUNIISPLATC P01BA02

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

Identification

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

Packs · 1

  • ndc11
    0093240101
    100 TABLET, FILM COATED in 1 BOTTLE (0093-2401-01)

Annotations

UNII (FDA Substance ID)
8Q2869CNVH
HYDROXYCHLOROQUINE SULFATE
RxCUI 153972
Orange Book
A040081
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": "0093-2401_0c6c28a5-e86f-4643-bb22-f7eb5b1f440d",
  "productndc": "0093-2401",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "040081",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Sep 30, 1994"
      }
    ],
    "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": "ANDA040081",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydroxychloroquine Sulfate",
  "start_marketing_date": "20201008",
  "active_numerator_strength": "200"
}

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