fulvestrant

Generic: fulvestrant

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fulvestrant
Generic Name fulvestrant
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

fulvestrant 50 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9022
Product ID 0143-9022_44dbf928-e93e-4f5e-8d1d-3b0e17f5d25f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214682
Listing Expiration 2027-12-31
Marketing Start 2022-02-10

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 01439022
Hyphenated Format 0143-9022

Supplemental Identifiers

RxCUI
727762
UPC
0301439022022
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 ANDA214682 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 2 SYRINGE, GLASS in 1 CARTON (0143-9022-02) / 5 mL in 1 SYRINGE, GLASS (0143-9022-01)
source: ndc

Packages (1)

0143-9022-02 2 SYRINGE, GLASS in 1 CARTON (0143-9022-02) / 5 mL in 1 SYRINGE, GLASS (0143-9022-01)

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": "44dbf928-e93e-4f5e-8d1d-3b0e17f5d25f", "openfda": {"nui": ["N0000175582", "N0000000145", "N0000000168"], "upc": ["0301439022022"], "unii": ["22X328QOC4"], "rxcui": ["727762"], "spl_set_id": ["306c283b-9abe-4985-856b-1957f1f3af8b"], "pharm_class_epc": ["Estrogen Receptor Antagonist [EPC]"], "pharm_class_moa": ["Estrogen Receptor Antagonists [MoA]", "Selective Estrogen Receptor Modulators [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE, GLASS in 1 CARTON (0143-9022-02)  / 5 mL in 1 SYRINGE, GLASS (0143-9022-01)", "package_ndc": "0143-9022-02", "marketing_start_date": "20220210"}], "brand_name": "Fulvestrant", "product_id": "0143-9022_44dbf928-e93e-4f5e-8d1d-3b0e17f5d25f", "dosage_form": "INJECTION", "pharm_class": ["Estrogen Receptor Antagonist [EPC]", "Estrogen Receptor Antagonists [MoA]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "0143-9022", "generic_name": "Fulvestrant", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fulvestrant", "active_ingredients": [{"name": "FULVESTRANT", "strength": "50 mg/mL"}], "application_number": "ANDA214682", "marketing_category": "ANDA", "marketing_start_date": "20220210", "listing_expiration_date": "20271231"}