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 4 of 10 · 197 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
FluorouracilFLUOROURACILGland Pharma Limited572b710e-8e2b-46eb-bd80-648ad769d34d2025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791736
rxcui: 1791701
unii: U3P01618RT
FluorouracilFLUOROURACILGland Pharma Limitedea3497db-23b9-4ace-9a6f-b54853d04a822025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 239177
unii: U3P01618RT
FluorouracilFLUOROURACILProPharma Distribution43057fcd-1f87-cc1a-e063-6294a90a8d242025-11-07Warnings, Adverse reactionsExact identifier
application number: ANDA040279
ndc (package): 84549-117-10
ndc (product): 84549-117
rxcui: 1791701
spl id: 43057fcd-1f86-cc1a-e063-6294a90a8d24
spl set id: 43057fcd-1f87-cc1a-e063-6294a90a8d24
unii: U3P01618RT
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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