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United States · US · US:0143-9022_44dbf928-e93e-4f5e-8d1d-3b0e17f5d25f
Fulvestrant
Orange BookUNIISPLATC L02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeL02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1101439022022 SYRINGE, GLASS in 1 CARTON (0143-9022-02) / 5 mL in 1 SYRINGE, GLASS (0143-9022-01)
Annotations
UNII (FDA Substance ID)
22X328QOC4
FULVESTRANT
RxCUI 282357
Orange Book
A214682
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": "0143-9022_44dbf928-e93e-4f5e-8d1d-3b0e17f5d25f",
"productndc": "0143-9022",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "214682",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AO",
"strength": "250MG/5ML (50MG/ML)",
"product_no": "001",
"approval_date": "Feb 10, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FULVESTRANT",
"proprietary_name": "Fulvestrant",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA214682",
"marketing_category": "ANDA",
"nonproprietary_name": "Fulvestrant",
"start_marketing_date": "20220210",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L02BA03.
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