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United States · US · US:0006-0032_200e22cc-3187-4a71-b8e1-73d90edab8bf

STROMECTOL

Orange BookUNIISPLATC D11AX22

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

Identification

ManufacturerMerck Sharp & Dohme LLC
CountryUS (United States)
ATC codeD11AX22
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0006003201
    2 BLISTER PACK in 1 CARTON (0006-0032-01) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    0006003220
    2 BLISTER PACK in 1 CARTON (0006-0032-20) / 10 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
8883YP2R6D
IVERMECTIN
RxCUI 6069
Orange Book
N050742
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "8883YP2R6D",
    "rxcui": "6069",
    "inchikey": null,
    "display_name": "IVERMECTIN",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "681888c9-af79-4b7d-ae80-c3f4f6f1effd": {
      "match": "brand_token",
      "title": "STROMECTOL (IVERMECTIN) TABLET [MERCK SHARP & DOHME LLC]",
      "spl_version": "20",
      "published_date": "2025-04-24"
    }
  },
  "productid": "0006-0032_200e22cc-3187-4a71-b8e1-73d90edab8bf",
  "productndc": "0006-0032",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "050742",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Nov 22, 1996"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "002",
        "approval_date": "Oct 8, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IVERMECTIN",
  "proprietary_name": "STROMECTOL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA050742",
  "marketing_category": "NDA",
  "nonproprietary_name": "ivermectin",
  "start_marketing_date": "19961122",
  "active_numerator_strength": "3"
}

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