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United States · US · US:0591-2712_071a50e4-8606-40a7-b09c-e7281ccac80b

Albendazole

Orange BookUNIISPLATC P02CA03

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeP02CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0591271202
    2 TABLET, FILM COATED in 1 BOTTLE (0591-2712-02)

Annotations

UNII (FDA Substance ID)
F4216019LN
ALBENDAZOLE
RxCUI 430
Orange Book
A208094
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "F4216019LN",
    "rxcui": "430",
    "inchikey": "HXHWSAZORRCQMX-UHFFFAOYSA-N",
    "display_name": "ALBENDAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8de337eb-92e1-15b5-e053-2a95a90ac4f1": {
      "match": "brand_token",
      "title": "ALBENDAZOLE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "4",
      "published_date": "2026-02-06"
    }
  },
  "productid": "0591-2712_071a50e4-8606-40a7-b09c-e7281ccac80b",
  "productndc": "0591-2712",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208094",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "May 20, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALBENDAZOLE",
  "proprietary_name": "Albendazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208094",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Albendazole",
  "start_marketing_date": "20190613",
  "active_numerator_strength": "200"
}

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