FDA.reportPublic FDA data

NDC 63323-715-01 - 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
63323-715
Requested NDC
63323-715-01
Package NDCs from labels
63323-715-01, 63323-715-05
Manufacturer
Fresenius Kabi USA, LLC | Fresenius Kabi Austria
Effective date
2024-01-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fulvestrant - Fresenius Kabi USA, LLC | Fresenius Kabi AustriaFresenius Kabi USA, LLC | Fresenius Kabi Austria2024-01-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-715-01Fulvestrant5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION56
63323-715-05Fulvestrant2 in 1 CARTONINJECTION, SOLUTION26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-715FULVESTRANT (FULVESTRANT) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 2 package rows20240308_fabe9bd8-ac23-4df1-a89a-223d5cd38914.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-715-01ML - Milliliter63323-71598bb3168-1095-4e33-bf3a-8f7a880e832612019-09-05
63323-715-05ML - Milliliter63323-715c178173f-deb0-43a3-9d76-184c7e9b083d12019-09-05

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 8 of 146 · 2,909 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B-Pure Moisturizing Hand Sanitizer with Hyaluronic Acid Enchanted Rose ScentedALCOHOLFourstar Group USA, Inc.b8216dd0-82e9-411c-b045-d6966a17f18e2026-08-06WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer with Collagen Sugared Iris ScentedALCOHOLFourstar Group USA, Inc.c5b42ae3-475d-444c-8ff0-784f02ec0ee42026-08-06WarningsExact identifier
unii: 3K9958V90M
Smart Care Sweet Pea HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.143082de-5f48-4229-a39e-fd6aa38acf302026-08-06WarningsExact identifier
unii: 3K9958V90M
Smart Care Cherry Blossom HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.ba91112c-5091-4972-84c9-5447eb0b504c2026-08-06WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer GelETHYL ALCOHOLApollo Health and Beauty Care5245e2a0-f871-ded0-e063-6394a90a86072026-08-05WarningsExact identifier
unii: 3K9958V90M
Vitamin E and AloeETHYL ALCOHOLApollo Health and Beauty Care52460290-a376-24b3-e063-6394a90a63482026-08-05WarningsExact identifier
unii: 3K9958V90M
Gingerbread Scented Hand SanitizerETHYL ALCOHOLPacific World Corporation5014eea8-6ee3-5ed2-e063-6294a90adac42026-08-05WarningsExact identifier
unii: 3K9958V90M
Frosted Cherry Scented Hand SanitizerETHYL ALCOHOLPacific World Corporation4ffcf42b-c650-7c76-e063-6394a90a059c2026-08-05WarningsExact identifier
unii: 3K9958V90M
BBlove Hand Sanitizer JAPANESE CHERRY BLOSSOMALCOHOLShenzhen Lantern Scicence Co.,Ltd.5833c261-021a-2db2-e063-6394a90a22b02026-08-04WarningsExact identifier
unii: 3K9958V90M
BBlove Hand Sanitizer Soft PetalsALCOHOLShenzhen Lantern Scicence Co.,Ltd.583438a6-c06c-87f5-e063-6394a90adec12026-08-04WarningsExact identifier
unii: 3K9958V90M
BBlove Hand Sanitizer Hibiscus and AloeALCOHOLShenzhen Lantern Scicence Co.,Ltd.5834801e-20e5-bffb-e063-6394a90a03592026-08-04WarningsExact identifier
unii: 3K9958V90M
Germs Be Gone Antiseptic Hand Sanitizer Clean and FreshALCOHOLRejoice Industries Canada Inc.1c11a785-d60c-4159-8e63-5ddcf88c23b02026-08-04WarningsExact identifier
unii: 3K9958V90M
MG DermaSpray 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.153ed8ff-5632-4f21-84de-2b87ac2bef312026-08-04WarningsExact identifier
unii: 3K9958V90M
ALCOHOL WIPEALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO.,LTD57086be5-b7a5-b61e-e063-6394a90abe792026-08-03WarningsExact identifier
unii: 3K9958V90M
Nail Treatment Repairing LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.57b8b3e5-88be-3a91-e063-6294a90a05be2026-08-03WarningsExact identifier
unii: D5340Y2I9G
BBlove Hand Sanitizer Passion Fruit SplashALCOHOLShenzhen Lantern Scicence Co.,Ltd.583159a9-331a-b53b-e063-6294a90a41a32026-08-03WarningsExact identifier
unii: 3K9958V90M
BBlove Hand Sanitizer Fresh Squeezed SpearmintALCOHOLShenzhen Lantern Scicence Co.,Ltd.581b4b8d-fe65-f297-e063-6394a90a5a432026-08-02WarningsExact identifier
unii: 3K9958V90M
Mistify Hand Sanitizer Cotton Candy and Gummy BearALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5987e492-b3b6-ed57-e063-6394a90a223a2026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Hand Sanitizer Soft Serve And Cherry CrushALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5987ed0c-2560-f787-e063-6394a90af7bd2026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Hand Sanitizer Coconut And Whipped CreamALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5988393d-1554-5588-e063-6394a90a470f2026-08-01WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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