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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
- ndc1103100720102 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"
}Related drugs
Other records sharing ATC code L02BA03.
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