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United States · US · US:25021-471_c42819d9-59df-44fa-aa7a-e510311dbbb8
fulvestrant
Orange BookUNIISPLATC L02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeL02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1125021471662 SYRINGE in 1 CARTON (25021-471-66) / 5 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
22X328QOC4
FULVESTRANT
RxCUI 282357
Orange Book
A211422
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": "25021-471_c42819d9-59df-44fa-aa7a-e510311dbbb8",
"productndc": "25021-471",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "211422",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AO",
"strength": "250MG/5ML (50MG/ML)",
"product_no": "001",
"approval_date": "Feb 7, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FULVESTRANT",
"proprietary_name": "fulvestrant",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA211422",
"marketing_category": "ANDA",
"nonproprietary_name": "fulvestrant",
"start_marketing_date": "20260415",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L02BA03.
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