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United States · US · US:0310-0720_9541dd80-09f9-4d3c-bb2a-fc354e198a2e

FASLODEX

Orange BookUNIISPLATC L02BA03

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

Identification

ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeL02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0310072010
    2 SYRINGE, GLASS in 1 CARTON (0310-0720-10) / 5 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)
22X328QOC4
FULVESTRANT
RxCUI 282357
Orange Book
N021344
AO
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "22X328QOC4",
    "rxcui": "282357",
    "inchikey": "VWUXBMIQPBEWFH-WCCTWKNTSA-N",
    "display_name": "FULVESTRANT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "83d7a440-e904-4e36-afb5-cb02b1c919f7": {
      "match": "brand_token",
      "title": "FASLODEX (FULVESTRANT) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]",
      "spl_version": "43",
      "published_date": "2026-02-16"
    }
  },
  "productid": "0310-0720_9541dd80-09f9-4d3c-bb2a-fc354e198a2e",
  "productndc": "0310-0720",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "021344",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AO",
        "strength": "250MG/5ML (50MG/ML)",
        "product_no": "001",
        "approval_date": "Apr 25, 2002"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "125MG/2.5ML (50MG/ML)",
        "product_no": "002",
        "approval_date": "Apr 25, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FULVESTRANT",
  "proprietary_name": "FASLODEX",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA021344",
  "marketing_category": "NDA",
  "nonproprietary_name": "Fulvestrant",
  "start_marketing_date": "20101101",
  "active_numerator_strength": "50"
}

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