fulvestrant

Generic: fulvestrant

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fulvestrant
Generic Name fulvestrant
Labeler accord healthcare inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

fulvestrant 250 mg/5mL

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-436
Product ID 16729-436_3001d1ed-b200-7d1b-e063-6394a90ab45f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211689
Listing Expiration 2026-12-31
Marketing Start 2021-01-21

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 16729436
Hyphenated Format 16729-436

Supplemental Identifiers

RxCUI
727762
UPC
0316729436311
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 ANDA211689 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 2 SYRINGE, GLASS in 1 CARTON (16729-436-30) / 5 mL in 1 SYRINGE, GLASS (16729-436-31)
source: ndc

Packages (1)

16729-436-30 2 SYRINGE, GLASS in 1 CARTON (16729-436-30) / 5 mL in 1 SYRINGE, GLASS (16729-436-31)

Ingredients (1)

fulvestrant (250 mg/5mL)

Linked Drug Pages (1)

FULVESTRANT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "3001d1ed-b200-7d1b-e063-6394a90ab45f", "openfda": {"nui": ["N0000175582", "N0000000145", "N0000000168"], "upc": ["0316729436311"], "unii": ["22X328QOC4"], "rxcui": ["727762"], "spl_set_id": ["b471eb51-488e-5312-e053-2a95a90a8116"], "pharm_class_epc": ["Estrogen Receptor Antagonist [EPC]"], "pharm_class_moa": ["Estrogen Receptor Antagonists [MoA]", "Selective Estrogen Receptor Modulators [MoA]"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE, GLASS in 1 CARTON (16729-436-30)  / 5 mL in 1 SYRINGE, GLASS (16729-436-31)", "package_ndc": "16729-436-30", "marketing_start_date": "20210121"}], "brand_name": "FULVESTRANT", "product_id": "16729-436_3001d1ed-b200-7d1b-e063-6394a90ab45f", "dosage_form": "INJECTION", "pharm_class": ["Estrogen Receptor Antagonist [EPC]", "Estrogen Receptor Antagonists [MoA]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "16729-436", "generic_name": "Fulvestrant", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FULVESTRANT", "active_ingredients": [{"name": "FULVESTRANT", "strength": "250 mg/5mL"}], "application_number": "ANDA211689", "marketing_category": "ANDA", "marketing_start_date": "20210121", "listing_expiration_date": "20261231"}