fulvestrant

Generic: fulvestrant

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fulvestrant
Generic Name fulvestrant
Labeler sandoz inc
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

fulvestrant 50 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3532
Product ID 0781-3532_99e95543-2f0d-4992-80ff-00a4f92d6e06
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205935
Listing Expiration 2026-12-31
Marketing Start 2023-11-01

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 07813532
Hyphenated Format 0781-3532

Supplemental Identifiers

RxCUI
727762
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 ANDA205935 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 2 SYRINGE, GLASS in 1 CARTON (0781-3532-12) / 5 mL in 1 SYRINGE, GLASS (0781-3532-01)
source: ndc

Packages (1)

0781-3532-12 2 SYRINGE, GLASS in 1 CARTON (0781-3532-12) / 5 mL in 1 SYRINGE, GLASS (0781-3532-01)

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": ["INTRAMUSCULAR"], "spl_id": "99e95543-2f0d-4992-80ff-00a4f92d6e06", "openfda": {"nui": ["N0000175582", "N0000000145", "N0000000168"], "unii": ["22X328QOC4"], "rxcui": ["727762"], "spl_set_id": ["141f439e-078c-4a59-acff-ebf7685f55b8"], "pharm_class_epc": ["Estrogen Receptor Antagonist [EPC]"], "pharm_class_moa": ["Estrogen Receptor Antagonists [MoA]", "Selective Estrogen Receptor Modulators [MoA]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE, GLASS in 1 CARTON (0781-3532-12)  / 5 mL in 1 SYRINGE, GLASS (0781-3532-01)", "package_ndc": "0781-3532-12", "marketing_start_date": "20231101"}], "brand_name": "Fulvestrant", "product_id": "0781-3532_99e95543-2f0d-4992-80ff-00a4f92d6e06", "dosage_form": "INJECTION", "pharm_class": ["Estrogen Receptor Antagonist [EPC]", "Estrogen Receptor Antagonists [MoA]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "0781-3532", "generic_name": "Fulvestrant", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fulvestrant", "active_ingredients": [{"name": "FULVESTRANT", "strength": "50 mg/mL"}], "application_number": "ANDA205935", "marketing_category": "ANDA", "marketing_start_date": "20231101", "listing_expiration_date": "20261231"}