fulvestrant

Generic: fulvestrant

Labeler: avenacy, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fulvestrant
Generic Name fulvestrant
Labeler avenacy, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

fulvestrant 50 mg/mL

Manufacturer
Avenacy, Inc.

Identifiers & Regulatory

Product NDC 83634-203
Product ID 83634-203_6ecfd7da-f2b6-453d-8105-5f6e0bf5e95f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211422
Listing Expiration 2026-12-31
Marketing Start 2024-02-28

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 83634203
Hyphenated Format 83634-203

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 ANDA211422 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 2 SYRINGE, GLASS in 1 CARTON (83634-203-74) / 5 mL in 1 SYRINGE, GLASS (83634-203-41)
source: ndc

Packages (1)

83634-203-74 2 SYRINGE, GLASS in 1 CARTON (83634-203-74) / 5 mL in 1 SYRINGE, GLASS (83634-203-41)

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": "6ecfd7da-f2b6-453d-8105-5f6e0bf5e95f", "openfda": {"nui": ["N0000175582", "N0000000145", "N0000000168"], "unii": ["22X328QOC4"], "rxcui": ["727762"], "spl_set_id": ["f44cffcc-8f5e-4a4c-a36e-ab946ce86266"], "pharm_class_epc": ["Estrogen Receptor Antagonist [EPC]"], "pharm_class_moa": ["Estrogen Receptor Antagonists [MoA]", "Selective Estrogen Receptor Modulators [MoA]"], "manufacturer_name": ["Avenacy, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE, GLASS in 1 CARTON (83634-203-74)  / 5 mL in 1 SYRINGE, GLASS (83634-203-41)", "package_ndc": "83634-203-74", "marketing_start_date": "20240228"}], "brand_name": "Fulvestrant", "product_id": "83634-203_6ecfd7da-f2b6-453d-8105-5f6e0bf5e95f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Estrogen Receptor Antagonist [EPC]", "Estrogen Receptor Antagonists [MoA]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "83634-203", "generic_name": "fulvestrant", "labeler_name": "Avenacy, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fulvestrant", "active_ingredients": [{"name": "FULVESTRANT", "strength": "50 mg/mL"}], "application_number": "ANDA211422", "marketing_category": "ANDA", "marketing_start_date": "20240228", "listing_expiration_date": "20261231"}