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United States · US · US:68382-209_577b7171-5da0-4291-af07-5e4653ffb3aa

Anastrozole

Orange BookUNIISPLATC L02BG03

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeL02BG03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6838220906
    30 TABLET, COATED in 1 BOTTLE (68382-209-06)
  • ndc11
    6838220910
    1000 TABLET, COATED in 1 BOTTLE (68382-209-10)

Annotations

UNII (FDA Substance ID)
2Z07MYW1AZ
ANASTROZOLE
RxCUI 84857
Orange Book
A078921
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2Z07MYW1AZ",
    "rxcui": "84857",
    "inchikey": "YBBLVLTVTVSKRW-UHFFFAOYSA-N",
    "display_name": "ANASTROZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "513e8413-af48-4acc-e063-6294a90a24b4": {
      "match": "brand_token",
      "title": "ANASTROZOLE (ANASTROZOLE TABLETS) TABLET [NUCARE PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-05-11"
    }
  },
  "productid": "68382-209_577b7171-5da0-4291-af07-5e4653ffb3aa",
  "productndc": "68382-209",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "078921",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Jun 28, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ANASTROZOLE",
  "proprietary_name": "Anastrozole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078921",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Anastrozole",
  "start_marketing_date": "20100627",
  "active_numerator_strength": "1"
}

Related drugs

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