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United States · US · US:16729-436_3001d1ed-b200-7d1b-e063-6394a90ab45f
FULVESTRANT
Orange BookUNIISPLATC L02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAccord Healthcare Inc.
CountryUS (United States)
ATC codeL02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1116729436302 SYRINGE, GLASS in 1 CARTON (16729-436-30) / 5 mL in 1 SYRINGE, GLASS (16729-436-31)
Annotations
UNII (FDA Substance ID)
22X328QOC4
FULVESTRANT
RxCUI 282357
Orange Book
A211689
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": "16729-436_3001d1ed-b200-7d1b-e063-6394a90ab45f",
"productndc": "16729-436",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "211689",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AO",
"strength": "250MG/5ML (50MG/ML)",
"product_no": "001",
"approval_date": "Nov 17, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FULVESTRANT",
"proprietary_name": "FULVESTRANT",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA211689",
"marketing_category": "ANDA",
"nonproprietary_name": "Fulvestrant",
"start_marketing_date": "20210121",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code L02BA03.
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