FDA.reportPublic FDA data

10 ML 5-5-fluorouracil 50 MG/ML Injection

RxCUI
1791701
RxNorm name
10 ML 5-5-fluorouracil 50 MG/ML Injection
Display name
10 ML 5-5-fluorouracil 50 MG/ML Injection
Full name
10 ML 5-5-fluorouracil 50 MG/ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluorouracilFLUOROURACILFresenius Kabi USA, LLCbeb8c6c5-4b6e-4770-b6d4-718e33c7a2ff2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791701
FluorouracilFLUOROURACILFresenius Kabi USA, LLCb4328ae3-f48f-40b1-9719-1c1aced7c7342026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791701
FluorouracilFLUOROURACILFresenius Kabi USA, LLCa85ab26a-05ea-498f-8f34-564a925fa9d92026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791701
FluorouracilFLUOROURACILFresenius Kabi USA, LLC21af1777-87f7-4e40-9917-f1677e7ff1a52026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791701
FluorouracilFLUOROURACILFresenius Kabi USA, LLCc45f5286-a52b-43e5-8a6f-d0312e7da0c82026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791701
FluorouracilFLUOROURACILBluePoint Laboratories9c42eeff-ab0c-4820-94d7-e1a3df9fda742026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791701
FluorouracilFLUOROURACILXiromed LLC19735014-c6fb-0a05-c330-2e9389c712162026-02-19Warnings, Adverse reactionsExact identifier
rxcui: 1791701
FluorouracilFLUOROURACILAccord Healthcare, Inc.8eff167f-203a-4a81-b2fc-d8773bc3555e2026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791701
FluorouracilFLUOROURACILAccord Healthcare, Inc.66d451fe-2436-494c-80c5-4528c8e343692026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791701
FLUOROURACILFLUOROURACILEugia US LLC199ef964-8a9b-403e-a2ae-759280b3d1d12026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791701
FluorouracilFLUOROURACILGland Pharma Limited572b710e-8e2b-46eb-bd80-648ad769d34d2025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1791701
FluorouracilFLUOROURACILProPharma Distribution43057fcd-1f87-cc1a-e063-6294a90a8d242025-11-07Warnings, Adverse reactionsExact identifier
rxcui: 1791701
FluorouracilFLUOROURACILFresenius Kabi USA, LLCfdf2a165-2ca4-48be-89c1-570e6010b47c2025-06-11Warnings, Adverse reactionsExact identifier
rxcui: 1791701

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 13 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
c45f5286-a52b-43e5-8a6f-d0312e7da0c8fluorouracil 500 MG in 10 ML Injection [PSN] · 10 ML fluorouracil 50 MG/ML Injection [SCD] · 10 ML 5-5-fluorouracil 50 MG/ML Injection [SY] · 10 ML 5-FU 50 MG/ML Injection [SY] · fluorouracil 500 MG per 10 ML Injection [SY]510These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 196220260319
572b710e-8e2b-46eb-bd80-648ad769d34dfluorouracil 500 MG in 10 ML Injection [PSN] · 10 ML fluorouracil 50 MG/ML Injection [SCD] · 10 ML 5-5-fluorouracil 50 MG/ML Injection [SY] · 10 ML 5-FU 50 MG/ML Injection [SY] · fluorouracil 500 MG per 10 ML Injection [SY]58These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 196220251110
19735014-c6fb-0a05-c330-2e9389c71216fluorouracil 500 MG in 10 ML Injection [PSN] · 10 ML fluorouracil 50 MG/ML Injection [SCD] · 10 ML 5-5-fluorouracil 50 MG/ML Injection [SY] · 10 ML 5-FU 50 MG/ML Injection [SY] · fluorouracil 500 MG per 10 ML Injection [SY]57These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 196220260219
beb8c6c5-4b6e-4770-b6d4-718e33c7a2fffluorouracil 500 MG in 10 ML Injection [PSN] · 10 ML fluorouracil 50 MG/ML Injection [SCD] · 10 ML 5-5-fluorouracil 50 MG/ML Injection [SY] · 10 ML 5-FU 50 MG/ML Injection [SY] · fluorouracil 500 MG per 10 ML Injection [SY]56These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package – Not for Direct Infusion Initial U.S. Approval: 196220260324
66d451fe-2436-494c-80c5-4528c8e34369fluorouracil 500 MG in 10 ML Injection [PSN] · 10 ML fluorouracil 50 MG/ML Injection [SCD] · 10 ML 5-5-fluorouracil 50 MG/ML Injection [SY] · 10 ML 5-FU 50 MG/ML Injection [SY] · fluorouracil 500 MG per 10 ML Injection [SY]56These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use only Initial U.S. Approval: 196220260209
9c42eeff-ab0c-4820-94d7-e1a3df9fda74fluorouracil 500 MG in 10 ML Injection [PSN] · 10 ML fluorouracil 50 MG/ML Injection [SCD] · 10 ML 5-5-fluorouracil 50 MG/ML Injection [SY] · 10 ML 5-FU 50 MG/ML Injection [SY] · fluorouracil 500 MG per 10 ML Injection [SY]55HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FLUOROURACIL injection safely and effectively. See full prescribing information for FLUOROURACIL injection. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 196220260226
8eff167f-203a-4a81-b2fc-d8773bc3555efluorouracil 500 MG in 10 ML Injection [PSN] · 10 ML fluorouracil 50 MG/ML Injection [SCD] · 10 ML 5-5-fluorouracil 50 MG/ML Injection [SY] · 10 ML 5-FU 50 MG/ML Injection [SY] · fluorouracil 500 MG per 10 ML Injection [SY]55These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package - Not for Direct Infusion Initial U.S. Approval: 196220260209
199ef964-8a9b-403e-a2ae-759280b3d1d1fluorouracil 500 MG in 10 ML Injection [PSN] · 10 ML fluorouracil 50 MG/ML Injection [SCD] · 10 ML 5-5-fluorouracil 50 MG/ML Injection [SY] · 10 ML 5-FU 50 MG/ML Injection [SY] · fluorouracil 500 MG per 10 ML Injection [SY]55These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 196220260119
a85ab26a-05ea-498f-8f34-564a925fa9d9fluorouracil 500 MG in 10 ML Injection [PSN] · 10 ML fluorouracil 50 MG/ML Injection [SCD] · 10 ML 5-5-fluorouracil 50 MG/ML Injection [SY] · 10 ML 5-FU 50 MG/ML Injection [SY] · fluorouracil 500 MG per 10 ML Injection [SY]55These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 196220250709
fdf2a165-2ca4-48be-89c1-570e6010b47cfluorouracil 500 MG in 10 ML Injection [PSN] · 10 ML fluorouracil 50 MG/ML Injection [SCD] · 10 ML 5-5-fluorouracil 50 MG/ML Injection [SY] · 10 ML 5-FU 50 MG/ML Injection [SY] · fluorouracil 500 MG per 10 ML Injection [SY]55These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 1962 Rx Only20250611
21af1777-87f7-4e40-9917-f1677e7ff1a5fluorouracil 500 MG in 10 ML Injection [PSN] · 10 ML fluorouracil 50 MG/ML Injection [SCD] · 10 ML 5-5-fluorouracil 50 MG/ML Injection [SY] · 10 ML 5-FU 50 MG/ML Injection [SY] · fluorouracil 500 MG per 10 ML Injection [SY]55These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package - Not for Direct Infusion Initial U.S. Approval: 196220241216
b4328ae3-f48f-40b1-9719-1c1aced7c734fluorouracil 500 MG in 10 ML Injection [PSN] · 10 ML fluorouracil 50 MG/ML Injection [SCD] · 10 ML 5-5-fluorouracil 50 MG/ML Injection [SY] · 10 ML 5-FU 50 MG/ML Injection [SY] · fluorouracil 500 MG per 10 ML Injection [SY]54These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Pharmacy Bulk Package – Not for Direct Infusion Initial U.S. Approval: 196220241219
43057fcd-1f87-cc1a-e063-6294a90a8d24fluorouracil 500 MG in 10 ML Injection [PSN] · 10 ML fluorouracil 50 MG/ML Injection [SCD] · 10 ML 5-5-fluorouracil 50 MG/ML Injection [SY] · 10 ML 5-FU 50 MG/ML Injection [SY] · fluorouracil 500 MG per 10 ML Injection [SY]51These highlights do not include all the information needed to use FLUOROURACIL INJECTION safely and effectively. See full prescribing information for FLUOROURACIL INJECTION. FLUOROURACIL injection, for intravenous use Initial U.S. Approval: 196220251107