fulvestrant

Generic: fulvestrant

Labeler: dr.reddy's laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fulvestrant
Generic Name fulvestrant
Labeler dr.reddy's laboratories inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

fulvestrant 50 mg/mL

Manufacturer
Dr.Reddy's Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-262
Product ID 43598-262_67af235f-7f8b-da5b-5eb6-91d0b20b2a9e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209246
Listing Expiration 2026-12-31
Marketing Start 2023-12-31

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 43598262
Hyphenated Format 43598-262

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 ANDA209246 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 2 SYRINGE, GLASS in 1 CARTON (43598-262-02) / 5 mL in 1 SYRINGE, GLASS (43598-262-11)
  • 2 SYRINGE, GLASS in 1 CARTON (43598-262-23) / 5 mL in 1 SYRINGE, GLASS (43598-262-11)
source: ndc

Packages (2)

43598-262-02 2 SYRINGE, GLASS in 1 CARTON (43598-262-02) / 5 mL in 1 SYRINGE, GLASS (43598-262-11) 43598-262-23 2 SYRINGE, GLASS in 1 CARTON (43598-262-23) / 5 mL in 1 SYRINGE, GLASS (43598-262-11)

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": "67af235f-7f8b-da5b-5eb6-91d0b20b2a9e", "openfda": {"nui": ["N0000175582", "N0000000145", "N0000000168"], "unii": ["22X328QOC4"], "rxcui": ["727762"], "spl_set_id": ["2fc17ba3-83c7-a2b4-8a75-6a0cb1e07682"], "pharm_class_epc": ["Estrogen Receptor Antagonist [EPC]"], "pharm_class_moa": ["Estrogen Receptor Antagonists [MoA]", "Selective Estrogen Receptor Modulators [MoA]"], "manufacturer_name": ["Dr.Reddy's Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE, GLASS in 1 CARTON (43598-262-02)  / 5 mL in 1 SYRINGE, GLASS (43598-262-11)", "package_ndc": "43598-262-02", "marketing_end_date": "20260531", "marketing_start_date": "20231231"}, {"sample": false, "description": "2 SYRINGE, GLASS in 1 CARTON (43598-262-23)  / 5 mL in 1 SYRINGE, GLASS (43598-262-11)", "package_ndc": "43598-262-23", "marketing_start_date": "20240905"}], "brand_name": "Fulvestrant", "product_id": "43598-262_67af235f-7f8b-da5b-5eb6-91d0b20b2a9e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Estrogen Receptor Antagonist [EPC]", "Estrogen Receptor Antagonists [MoA]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "43598-262", "generic_name": "Fulvestrant", "labeler_name": "Dr.Reddy's Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fulvestrant", "active_ingredients": [{"name": "FULVESTRANT", "strength": "50 mg/mL"}], "application_number": "ANDA209246", "marketing_category": "ANDA", "marketing_start_date": "20231231", "listing_expiration_date": "20261231"}