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United States · US · US:70771-1731_865fe6e0-775f-439c-97d3-762298423d78

Ivermectin

Orange BookUNIISPLATC D11AX22

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeD11AX22
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7077117313
    2 BLISTER PACK in 1 CARTON (70771-1731-3) / 10 TABLET in 1 BLISTER PACK (70771-1731-2)

Annotations

UNII (FDA Substance ID)
8883YP2R6D
IVERMECTIN
RxCUI 6069
Orange Book
A216863
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": {
    "03ab6529-ecef-4bf3-867c-0c4c3d3959c2": {
      "match": "brand_token",
      "title": "IVERMECTIN PASTE [GUANGZHOU AIMAIXUN TECHNOLOGY CO., LTD.]",
      "spl_version": "1",
      "published_date": "2026-05-13"
    }
  },
  "productid": "70771-1731_865fe6e0-775f-439c-97d3-762298423d78",
  "productndc": "70771-1731",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216863",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG",
        "product_no": "001",
        "approval_date": "Feb 26, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IVERMECTIN",
  "proprietary_name": "Ivermectin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216863",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ivermectin",
  "start_marketing_date": "20260227",
  "active_numerator_strength": "3"
}

Related drugs

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