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United States · US · US:0115-1701_2da2a777-2835-429d-b73a-31b8e0bde571

Albendazole

Orange BookUNIISPLATC P02CA03

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeP02CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0115170149
    2 TABLET, FILM COATED in 1 BOTTLE (0115-1701-49)

Annotations

UNII (FDA Substance ID)
F4216019LN
ALBENDAZOLE
RxCUI 430
Orange Book
N020666
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": "0115-1701_2da2a777-2835-429d-b73a-31b8e0bde571",
  "productndc": "0115-1701",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020666",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jun 11, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALBENDAZOLE",
  "proprietary_name": "Albendazole",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020666",
  "marketing_category": "NDA",
  "nonproprietary_name": "albendazole",
  "start_marketing_date": "19960611",
  "active_numerator_strength": "200"
}

Related drugs

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