NDC 43598-262-11 - Fulvestrant

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 43598-262
Requested NDC: 43598-262-11
Package NDCs from labels: 43598-262-11, 43598-262-02, 43598-262-23
Manufacturer: Dr.Reddy's Laboratories Inc | Dr.Reddy's Laboratories Limited-FTO-9
Effective date: 2025-11-01
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Fulvestrant - Dr.Reddy's Laboratories Inc \| Dr.Reddy's Laboratories Limited-FTO-9	Dr.Reddy's Laboratories Inc \| Dr.Reddy's Laboratories Limited-FTO-9	2025-11-01	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43598-262-02	Fulvestrant	2 in 1 CARTON	INJECTION, SOLUTION	2	19
43598-262-11	Fulvestrant	5 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	5	19
43598-262-23	Fulvestrant	2 in 1 CARTON	INJECTION, SOLUTION	2	19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-262	FULVESTRANT INJECTION, SOLUTION [DR.REDDY'S LABORATORIES INC]	19	Current NDC, Legacy NDC, 3 package rows	20240906_2fc17ba3-83c7-a2b4-8a75-6a0cb1e07682.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-262-02	ML - Milliliter	43598-262	ffea5f6c-7731-4740-a3f9-edad8d056f49	1	2020-09-14
43598-262-11	ML - Milliliter	43598-262	03ff9a88-c9c3-4495-be64-9a6c0bc83841	1	2020-09-14
43598-262-23	ML - Milliliter	43598-262	a0670a5a-4694-44ec-9686-8ad954149217	1	2024-10-04

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FULVESTRANT	FULVESTRANT	Zydus Lifesciences Limited	151b948a-3106-497a-b1c7-479307faeb89	2022-08-26		Exact identifier rxcui: 727762 unii: 22X328QOC4
FULVESTRANT	FULVESTRANT	Xiromed, LLC	840cd7c0-9f33-f74e-f136-de7fe899bfb4	2021-10-04	Warnings, Adverse reactions	Exact identifier rxcui: 727762 unii: 22X328QOC4
FULVESTRANT	FULVESTRANT	Northstar Rx, LLC,	67566681-19b5-89df-2030-25df5b0cf641	2021-08-23	Warnings, Adverse reactions	Exact identifier rxcui: 727762 unii: 22X328QOC4
FASLODEX	FULVESTRANT	AstraZeneca Pharmaceuticals LP	83d7a440-e904-4e36-afb5-cb02b1c919f7	2020-09-25	Warnings, Adverse reactions	Exact identifier rxcui: 727762 unii: 22X328QOC4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.