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United States · US · US:71288-555_2be67b09-31de-41b4-9468-a73a284abe41
Fulvestrant
Orange BookUNIISPLATC L02BA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMeitheal Pharmaceuticals Inc
CountryUS (United States)
ATC codeL02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171288555862 SYRINGE in 1 CARTON (71288-555-86) / 5 mL in 1 SYRINGE (71288-555-85)
Annotations
UNII (FDA Substance ID)
22X328QOC4
FULVESTRANT
RxCUI 282357
Orange Book
A209714
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": "71288-555_2be67b09-31de-41b4-9468-a73a284abe41",
"productndc": "71288-555",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "209714",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AO",
"strength": "250MG/5ML (50MG/ML)",
"product_no": "001",
"approval_date": "Nov 21, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FULVESTRANT",
"proprietary_name": "Fulvestrant",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA209714",
"marketing_category": "ANDA",
"nonproprietary_name": "Fulvestrant",
"start_marketing_date": "20191121",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code L02BA03.
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