FDA.reportPublic FDA data

NDC 63323-117-01 - Fluorouracil

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
63323-117
Requested NDC
63323-117-01
Package NDCs from labels
63323-117-51, 63323-117-61, 63323-117-59, 63323-117-69, 63323-117-43, 63323-117-18, 63323-117-41, 63323-117-28, 63323-117-58, 63323-117-68, 63323-117-00, 63323-117-10, 63323-117-01, 63323-117-20, 63323-117-31, 63323-117-19
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2026-07-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluorouracil - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2026-07-15HUMAN PRESCRIPTION DRUG LABEL
Fluorouracil - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2026-06-10HUMAN PRESCRIPTION DRUG LABEL
Fluorouracil - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2026-06-09HUMAN PRESCRIPTION DRUG LABEL
Fluorouracil - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2026-06-08HUMAN PRESCRIPTION DRUG LABEL
Fluorouracil - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2026-03-19HUMAN PRESCRIPTION DRUG LABEL
Fluorouracil - ProPharma DistributionProPharma Distribution2025-11-07HUMAN PRESCRIPTION DRUG LABEL
Fluorouracil - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2025-06-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-117-00Fluorouracil10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1010
63323-117-01Fluorouracil20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2010
63323-117-10Fluorouracil10 in 1 TRAYINJECTION, SOLUTION1010
63323-117-20Fluorouracil10 in 1 TRAYINJECTION, SOLUTION1010
63323-117-51Fluorouracil1 in 1 CARTONINJECTION, SOLUTION16
63323-117-51Fluorouracil50 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, SOLUTION506
63323-117-61Fluorouracil100 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, SOLUTION1006
63323-117-61Fluorouracil1 in 1 CARTONINJECTION, SOLUTION16
63323-117-18Fluorouracil10 in 1 TRAYINJECTION, SOLUTION105
63323-117-19Fluorouracil10 in 1 TRAYINJECTION, SOLUTION105
63323-117-28Fluorouracil10 in 1 TRAYINJECTION, SOLUTION105
63323-117-31Fluorouracil10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION105
63323-117-41Fluorouracil20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION205
63323-117-43Fluorouracil10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION105
63323-117-58Fluorouracil50 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, SOLUTION505
63323-117-58Fluorouracil1 in 1 CARTONINJECTION, SOLUTION15
63323-117-68Fluorouracil1 in 1 CARTONINJECTION, SOLUTION15
63323-117-68Fluorouracil100 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, SOLUTION1005
63323-117-59Fluorouracil1 in 1 CARTONINJECTION, SOLUTION14
63323-117-59Fluorouracil50 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, SOLUTION504
63323-117-69Fluorouracil1 in 1 CARTONINJECTION, SOLUTION14
63323-117-69Fluorouracil100 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, SOLUTION1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-117FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]8Current NDC, Legacy NDC, 4 package rows20241013_c45f5286-a52b-43e5-8a6f-d0312e7da0c8.zip
63323-117FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 4 package rows20250129_21af1777-87f7-4e40-9917-f1677e7ff1a5.zip
63323-117FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 4 package rows20241122_beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff.zip
63323-117FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 4 package rows20241013_a85ab26a-05ea-498f-8f34-564a925fa9d9.zip
63323-117FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20241013_fdf2a165-2ca4-48be-89c1-570e6010b47c.zip
63323-117FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 4 package rows20250129_b4328ae3-f48f-40b1-9719-1c1aced7c734.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-117-00ML - Milliliter63323-117267f8c91-9271-4391-8413-b8534354b9bb12021-06-02
63323-117-01ML - Milliliter63323-11725630258-6f5e-4e82-98db-d6667281b1cd12021-10-08
63323-117-10ML - Milliliter63323-117b86648e5-1e8a-4a65-a398-fb7db9da36f912012-07-24
63323-117-18ML - Milliliter63323-117a8ce7c14-50ae-4b07-9b35-da999bf9c0e512014-10-03
63323-117-19ML - Milliliter63323-11761608534-5005-4a4b-ba86-98c7249fc58f12014-07-02
63323-117-20ML - Milliliter63323-11727b634db-662c-4a9d-9386-a196824f0fa012012-07-24
63323-117-28ML - Milliliter63323-117d7d2e357-2980-494b-bf20-ca90f62d27d212014-10-03
63323-117-31ML - Milliliter63323-117d7082dec-2d1e-45dd-8c82-8806774751de12021-10-08
63323-117-41ML - Milliliter63323-117b489ed5f-459d-4062-8483-e01ec52b018212021-11-09
63323-117-43ML - Milliliter63323-11790156463-0404-45a1-9890-9562e9faf7d512022-09-12
63323-117-51ML - Milliliter63323-1172597a576-0566-45e0-9735-1a28c6574fcb12013-02-13
63323-117-58ML - Milliliter63323-117637d5028-3696-4710-af67-df86d525938212014-10-03
63323-117-59ML - Milliliter63323-117c9225942-73ea-4111-be14-c910b277b1e712014-07-02
63323-117-61ML - Milliliter63323-11795dbcf0a-7f3a-4bb9-8ac8-5d11ab9bd39b12013-02-13
63323-117-68ML - Milliliter63323-117ac74a78b-73ec-4052-b0b1-a5b1e0befb1112014-10-03
63323-117-69ML - Milliliter63323-117570693b7-ae18-4fc2-a2e1-8ead6b0c1bad12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOROURACILACTIVE INGREDIENTU3P01618RTFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
FLUOROURACILACTIVE INGREDIENTU3P01618RTFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
FLUOROURACILACTIVE INGREDIENTU3P01618RTFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
FLUOROURACILACTIVE MOIETYU3P01618RTFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
FLUOROURACILACTIVE MOIETYU3P01618RTFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
FLUOROURACILACTIVE MOIETYU3P01618RTFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
FLUOROURACILACTIVE INGREDIENTU3P01618RTFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
FLUOROURACILACTIVE INGREDIENTU3P01618RTFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
FLUOROURACILACTIVE INGREDIENTU3P01618RTFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
FLUOROURACILACTIVE MOIETYU3P01618RTFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
FLUOROURACILACTIVE MOIETYU3P01618RTFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
FLUOROURACILACTIVE MOIETYU3P01618RTFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1

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 3 of 10 · 197 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
FluorouracilFLUOROURACILXiromed LLC19735014-c6fb-0a05-c330-2e9389c712162026-02-19Warnings, Adverse reactionsExact identifier
rxcui: 1791736
rxcui: 1791701
unii: U3P01618RT
FluorouracilFLUOROURACILXiromed LLCf4b0cae1-a2fc-2991-d663-3b729503cd1c2026-02-19Warnings, Adverse reactionsExact identifier
rxcui: 239177
unii: U3P01618RT
FluorouracilFLUOROURACILAccord Healthcare, Inc.8eff167f-203a-4a81-b2fc-d8773bc3555e2026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791736
rxcui: 1791701
rxcui: 239177
unii: U3P01618RT
FluorouracilFLUOROURACILAccord Healthcare, Inc.66d451fe-2436-494c-80c5-4528c8e343692026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791736
rxcui: 1791701
rxcui: 239177
unii: U3P01618RT
fluorouracilFLUOROURACILSagent Pharmaceuticals37e35e8c-5d51-413b-a3a0-b72a18caaf652026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 239177
unii: U3P01618RT
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FLUOROURACILFLUOROURACILEugia US LLC697816ce-dc05-4943-b7f0-2f0b125e93b72026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 239177
unii: U3P01618RT
FLUOROURACILFLUOROURACILEugia US LLC199ef964-8a9b-403e-a2ae-759280b3d1d12026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791736
rxcui: 1791701
unii: U3P01618RT
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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