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United States · US · US:63323-715_c584c51e-3ce0-4682-a4dd-d0ac149201a8
Fulvestrant
Orange BookUNIISPLATC L02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163323715052 SYRINGE, GLASS in 1 CARTON (63323-715-05) / 5 mL in 1 SYRINGE, GLASS (63323-715-01)
Annotations
UNII (FDA Substance ID)
22X328QOC4
FULVESTRANT
RxCUI 282357
Orange Book
N210326
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": {
"d5ae9e07-73b0-4063-a9e4-0ffc5614c2b8": {
"match": "brand_token",
"title": "FULVESTRANT INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]",
"spl_version": "1",
"published_date": "2026-04-15"
}
},
"productid": "63323-715_c584c51e-3ce0-4682-a4dd-d0ac149201a8",
"productndc": "63323-715",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "210326",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AO",
"strength": "250MG/5ML (50MG/ML)",
"product_no": "001",
"approval_date": "May 20, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FULVESTRANT",
"proprietary_name": "Fulvestrant",
"active_ingred_unit": "mg/mL",
"application_number": "NDA210326",
"marketing_category": "NDA",
"nonproprietary_name": "Fulvestrant",
"start_marketing_date": "20190520",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L02BA03.
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