fulvestrant

Generic: fulvestrant

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fulvestrant
Generic Name fulvestrant
Labeler eugia us llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

fulvestrant 50 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-394
Product ID 55150-394_01fb9018-5093-40e6-bfea-83dee3a5ffc0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215169
Listing Expiration 2026-12-31
Marketing Start 2023-06-30

Pharmacologic Class

Established (EPC)
estrogen receptor antagonist [epc]
Mechanism of Action
estrogen receptor antagonists [moa] selective estrogen receptor modulators [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150394
Hyphenated Format 55150-394

Supplemental Identifiers

RxCUI
727762
UPC
0355150394012 0355150394029
UNII
22X328QOC4
NUI
N0000175582 N0000000145 N0000000168

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fulvestrant (source: ndc)
Generic Name fulvestrant (source: ndc)
Application Number ANDA215169 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 2 SYRINGE in 1 CARTON (55150-394-02) / 5 mL in 1 SYRINGE
source: ndc

Packages (1)

55150-394-02 2 SYRINGE in 1 CARTON (55150-394-02) / 5 mL in 1 SYRINGE

Ingredients (1)

fulvestrant (50 mg/mL)

Linked Drug Pages (1)

Fulvestrant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "01fb9018-5093-40e6-bfea-83dee3a5ffc0", "openfda": {"nui": ["N0000175582", "N0000000145", "N0000000168"], "upc": ["0355150394012", "0355150394029"], "unii": ["22X328QOC4"], "rxcui": ["727762"], "spl_set_id": ["80b6dfe6-449d-4e2f-af90-bfbf9b04163b"], "pharm_class_epc": ["Estrogen Receptor Antagonist [EPC]"], "pharm_class_moa": ["Estrogen Receptor Antagonists [MoA]", "Selective Estrogen Receptor Modulators [MoA]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE in 1 CARTON (55150-394-02)  / 5 mL in 1 SYRINGE", "package_ndc": "55150-394-02", "marketing_start_date": "20230630"}], "brand_name": "Fulvestrant", "product_id": "55150-394_01fb9018-5093-40e6-bfea-83dee3a5ffc0", "dosage_form": "INJECTION", "pharm_class": ["Estrogen Receptor Antagonist [EPC]", "Estrogen Receptor Antagonists [MoA]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "55150-394", "generic_name": "Fulvestrant", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fulvestrant", "active_ingredients": [{"name": "FULVESTRANT", "strength": "50 mg/mL"}], "application_number": "ANDA215169", "marketing_category": "ANDA", "marketing_start_date": "20230630", "listing_expiration_date": "20261231"}