faslodex

Generic: fulvestrant

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name faslodex
Generic Name fulvestrant
Labeler astrazeneca pharmaceuticals lp
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

fulvestrant 50 mg/mL

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-0720
Product ID 0310-0720_9541dd80-09f9-4d3c-bb2a-fc354e198a2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021344
Listing Expiration 2027-12-31
Marketing Start 2010-11-01

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 03100720
Hyphenated Format 0310-0720

Supplemental Identifiers

RxCUI
727762 727954
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 faslodex (source: ndc)
Generic Name fulvestrant (source: ndc)
Application Number NDA021344 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 2 SYRINGE, GLASS in 1 CARTON (0310-0720-10) / 5 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

0310-0720-10 2 SYRINGE, GLASS in 1 CARTON (0310-0720-10) / 5 mL in 1 SYRINGE, GLASS

Ingredients (1)

fulvestrant (50 mg/mL)

Linked Drug Pages (1)

FASLODEX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "9541dd80-09f9-4d3c-bb2a-fc354e198a2e", "openfda": {"nui": ["N0000175582", "N0000000145", "N0000000168"], "unii": ["22X328QOC4"], "rxcui": ["727762", "727954"], "spl_set_id": ["83d7a440-e904-4e36-afb5-cb02b1c919f7"], "pharm_class_epc": ["Estrogen Receptor Antagonist [EPC]"], "pharm_class_moa": ["Estrogen Receptor Antagonists [MoA]", "Selective Estrogen Receptor Modulators [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE, GLASS in 1 CARTON (0310-0720-10)  / 5 mL in 1 SYRINGE, GLASS", "package_ndc": "0310-0720-10", "marketing_start_date": "20101101"}], "brand_name": "FASLODEX", "product_id": "0310-0720_9541dd80-09f9-4d3c-bb2a-fc354e198a2e", "dosage_form": "INJECTION", "pharm_class": ["Estrogen Receptor Antagonist [EPC]", "Estrogen Receptor Antagonists [MoA]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "0310-0720", "generic_name": "Fulvestrant", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FASLODEX", "active_ingredients": [{"name": "FULVESTRANT", "strength": "50 mg/mL"}], "application_number": "NDA021344", "marketing_category": "NDA", "marketing_start_date": "20101101", "listing_expiration_date": "20271231"}