fulvestrant

Generic: fulvestrant

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fulvestrant
Generic Name fulvestrant
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

fulvestrant 50 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-471
Product ID 25021-471_fe82b170-2347-474e-93cb-c4fe66d1834e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211422
Listing Expiration 2026-12-31
Marketing Start 2024-09-15

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 25021471
Hyphenated Format 25021-471

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 in 1 CARTON (25021-471-74) / 5 mL in 1 SYRINGE
source: ndc

Packages (1)

25021-471-74 2 SYRINGE in 1 CARTON (25021-471-74) / 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": ["INTRAMUSCULAR"], "spl_id": "fe82b170-2347-474e-93cb-c4fe66d1834e", "openfda": {"nui": ["N0000175582", "N0000000145", "N0000000168"], "unii": ["22X328QOC4"], "rxcui": ["727762"], "spl_set_id": ["0f05b699-c440-42c1-9557-46759a10ab17"], "pharm_class_epc": ["Estrogen Receptor Antagonist [EPC]"], "pharm_class_moa": ["Estrogen Receptor Antagonists [MoA]", "Selective Estrogen Receptor Modulators [MoA]"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE in 1 CARTON (25021-471-74)  / 5 mL in 1 SYRINGE", "package_ndc": "25021-471-74", "marketing_start_date": "20240915"}], "brand_name": "fulvestrant", "product_id": "25021-471_fe82b170-2347-474e-93cb-c4fe66d1834e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Estrogen Receptor Antagonist [EPC]", "Estrogen Receptor Antagonists [MoA]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "25021-471", "generic_name": "fulvestrant", "labeler_name": "Sagent Pharmaceuticals", "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": "20240915", "listing_expiration_date": "20261231"}