Back to search
🇺🇸

United States · US · US:64896-693_6163d9cc-fcc2-40a8-9b3d-0cce16b99b27

ALBENZA

Orange BookUNIISPLATC P02CA03

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

Identification

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

Packs · 1

  • ndc11
    6489669349
    2 TABLET, FILM COATED in 1 BOTTLE (64896-693-49)

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": {
    "1977a867-0ee1-44c0-8da3-fe59c48699f5": {
      "match": "brand_token",
      "title": "ALBENZA (ALBENDAZOLE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "14",
      "published_date": "2024-10-25"
    }
  },
  "productid": "64896-693_6163d9cc-fcc2-40a8-9b3d-0cce16b99b27",
  "productndc": "64896-693",
  "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        "strength": "200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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": "ALBENZA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020666",
  "marketing_category": "NDA",
  "nonproprietary_name": "albendazole",
  "start_marketing_date": "19960611",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code P02CA03.

Access this data programmatically

Query ALBENZA and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.