FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Fulvestrant - Dr.Reddy's Laboratories Inc | Dr.Reddy's Laboratories Limited-FTO-9Dr.Reddy's Laboratories Inc | Dr.Reddy's Laboratories Limited-FTO-92025-11-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-262-02Fulvestrant2 in 1 CARTONINJECTION, SOLUTION219
43598-262-11Fulvestrant5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION519
43598-262-23Fulvestrant2 in 1 CARTONINJECTION, SOLUTION219

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-262FULVESTRANT INJECTION, SOLUTION [DR.REDDY'S LABORATORIES INC]19Current NDC, Legacy NDC, 3 package rows20240906_2fc17ba3-83c7-a2b4-8a75-6a0cb1e07682.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-262-02ML - Milliliter43598-262ffea5f6c-7731-4740-a3f9-edad8d056f4912020-09-14
43598-262-11ML - Milliliter43598-26203ff9a88-c9c3-4495-be64-9a6c0bc8384112020-09-14
43598-262-23ML - Milliliter43598-262a0670a5a-4694-44ec-9686-8ad95414921712024-10-04

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 1 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLIGAVYXFULVESTRANTAvyxa Pharma, LLCe20d8ca3-8837-4003-8b01-1ebec342062a2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
fulvestrantFULVESTRANTSagent Pharmaceuticalsd5ae9e07-73b0-4063-a9e4-0ffc5614c2b82026-03-05Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FulvestrantFULVESTRANTGLENMARK PHARMACEUTICALS INC., USA99cf8b69-4c23-4886-80e9-b23e348b5bd72026-02-27Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FulvestrantFULVESTRANTChia Tai Tianqing Pharmaceutical Group Co., Ltd.46086fe7-190d-4963-97bc-1fe22d36e6d22025-12-23Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FulvestrantFULVESTRANTAlembic Pharmaceuticals Inc.b02915fe-6c44-48c1-aaeb-997ddc59a5952025-08-18Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FulvestrantFULVESTRANTBluePoint Laboratories.57352662-d2fa-4dce-828f-4c51e46e0b4d2025-07-25Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FulvestrantFULVESTRANTEugia US LLC80b6dfe6-449d-4e2f-af90-bfbf9b04163b2025-07-03Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FulvestrantFULVESTRANTBluePoint Laboratoriesbc7b4eac-3b63-53d2-e053-2995a90ad5e72025-06-24Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FulvestrantFULVESTRANTAmneal Pharmaceuticals LLCf36f19ad-f044-4dba-80b6-d074ddffcd862025-05-30Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FulvestrantFULVESTRANTAmneal Pharmaceuticals LLCa51aa693-b433-4b2d-a71b-9ba029b10ce32025-04-30Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FULVESTRANTFULVESTRANTAccord Healthcare Inc.b471eb51-488e-5312-e053-2a95a90a81162025-03-10Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FulvestrantFULVESTRANTHikma Pharmaceuticals USA Inc.306c283b-9abe-4985-856b-1957f1f3af8b2025-02-10Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FulvestrantFULVESTRANTAthenex Pharmaceutical Division, LLC.8ed06e0e-c17b-4c71-8d03-888bcde4a6382025-01-28Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FULVESTRANTFULVESTRANTZydus Pharmaceuticals USA Inc.994edf79-20a5-4e3a-bb35-c4fe3e65acba2024-08-20Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FulvestrantFULVESTRANTDr.Reddy's Laboratories Inc2fc17ba3-83c7-a2b4-8a75-6a0cb1e076822024-07-31Warnings, Adverse reactionsExact identifier
application number: ANDA209246
ndc (package): 43598-262-23
ndc (package): 43598-262-11
ndc (package): 43598-262-02
ndc (product): 43598-262
ndc11 (package): 43598026211
rxcui: 727762
spl id: 67af235f-7f8b-da5b-5eb6-91d0b20b2a9e
spl set id: 2fc17ba3-83c7-a2b4-8a75-6a0cb1e07682
unii: 22X328QOC4
FulvestrantFULVESTRANTMeitheal Pharmaceuticals Inc015fafb6-23f7-4566-9c23-386eee7b035d2024-06-17Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FulvestrantFULVESTRANTAvenacy, Inc.f44cffcc-8f5e-4a4c-a36e-ab946ce862662024-02-28Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FulvestrantFULVESTRANTFresenius Kabi USA, LLCfabe9bd8-ac23-4df1-a89a-223d5cd389142024-01-31Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FulvestrantFULVESTRANTSandoz Inc7a03f714-b109-4256-80a6-78c82127d6242022-09-21Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4
FulvestrantFULVESTRANTSandoz Inc141f439e-078c-4a59-acff-ebf7685f55b82022-09-13Warnings, Adverse reactionsExact identifier
rxcui: 727762
unii: 22X328QOC4

Reported adverse events (FAERS/openFDA)#

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