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 | Type |
|---|---|---|---|
| Fluorouracil - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2026-07-15 | HUMAN PRESCRIPTION DRUG LABEL |
| Fluorouracil - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2026-06-10 | HUMAN PRESCRIPTION DRUG LABEL |
| Fluorouracil - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2026-06-09 | HUMAN PRESCRIPTION DRUG LABEL |
| Fluorouracil - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2026-06-08 | HUMAN PRESCRIPTION DRUG LABEL |
| Fluorouracil - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2026-03-19 | HUMAN PRESCRIPTION DRUG LABEL |
| Fluorouracil - ProPharma Distribution | ProPharma Distribution | 2025-11-07 | HUMAN PRESCRIPTION DRUG LABEL |
| Fluorouracil - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2025-06-11 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-117-00 | Fluorouracil | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | 10 | |
| 63323-117-01 | Fluorouracil | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 20 | 10 | |
| 63323-117-10 | Fluorouracil | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | 10 | |
| 63323-117-20 | Fluorouracil | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | 10 | |
| 63323-117-51 | Fluorouracil | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 6 | |
| 63323-117-51 | Fluorouracil | 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, SOLUTION | 50 | 6 | |
| 63323-117-61 | Fluorouracil | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, SOLUTION | 100 | 6 | |
| 63323-117-61 | Fluorouracil | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 6 | |
| 63323-117-18 | Fluorouracil | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | 5 | |
| 63323-117-19 | Fluorouracil | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | 5 | |
| 63323-117-28 | Fluorouracil | 10 in 1 TRAY | INJECTION, SOLUTION | 10 | 5 | |
| 63323-117-31 | Fluorouracil | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | 5 | |
| 63323-117-41 | Fluorouracil | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 20 | 5 | |
| 63323-117-43 | Fluorouracil | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | 5 | |
| 63323-117-58 | Fluorouracil | 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, SOLUTION | 50 | 5 | |
| 63323-117-58 | Fluorouracil | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 5 | |
| 63323-117-68 | Fluorouracil | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 5 | |
| 63323-117-68 | Fluorouracil | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, SOLUTION | 100 | 5 | |
| 63323-117-59 | Fluorouracil | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 4 | |
| 63323-117-59 | Fluorouracil | 50 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, SOLUTION | 50 | 4 | |
| 63323-117-69 | Fluorouracil | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 4 | |
| 63323-117-69 | Fluorouracil | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE | INJECTION, SOLUTION | 100 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-117 | FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 8 | Current NDC, Legacy NDC, 4 package rows | 20241013_c45f5286-a52b-43e5-8a6f-d0312e7da0c8.zip |
| 63323-117 | FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250129_21af1777-87f7-4e40-9917-f1677e7ff1a5.zip |
| 63323-117 | FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20241122_beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff.zip |
| 63323-117 | FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20241013_a85ab26a-05ea-498f-8f34-564a925fa9d9.zip |
| 63323-117 | FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241013_fdf2a165-2ca4-48be-89c1-570e6010b47c.zip |
| 63323-117 | FLUOROURACIL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20250129_b4328ae3-f48f-40b1-9719-1c1aced7c734.zip |
DailyMed Billing Units#
DailyMed Socrata Ingredients#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Remodulin | TREPROSTINIL | United Therapeutics Corporation | 6c80bb38-e8db-4138-9f0d-dbbf9c673185 | 2026-07-02 | Warnings, Adverse reactions | 059QF0KO0R |
| Fendall 2000 Pure Flow | PURIFIED WATER | Honeywell Safety Products USA, Inc. | 37dead3e-60cb-88ae-e063-6294a90a8f70 | 2026-06-24 | Warnings | 059QF0KO0R |
| Bacteriostatic Water | BACTERIOSTATIC WATER | Fujian Genohope Biotech Ltd. | 54f66b82-c9e5-a2bc-e063-6394a90adbbc | 2026-06-23 | 059QF0KO0R | |
| Humalog | INSULIN LISPRO | Eli Lilly and Company | c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f | 2026-06-16 | Warnings, Adverse reactions | 059QF0KO0R |
| BM BM70 DROPS | ANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALB | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 54113d1f-e8e7-6b4c-e063-6394a90a0edf | 2026-06-12 | Warnings | 059QF0KO0R |
| BM BM70 DROPS | ANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALB | BM Private Limited | 53fa21d9-1f80-2e69-e063-6394a90ab9f3 | 2026-06-11 | Warnings | 059QF0KO0R |
| Fluorouracil | FLUOROURACIL | Fresenius Kabi USA, LLC | b4328ae3-f48f-40b1-9719-1c1aced7c734 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | ANDA040278 63323-117-69 63323-117-59 63323-117 1791736 1791701 239177 72e70086-5049-42bd-80f0-f1b6a456c77d b4328ae3-f48f-40b1-9719-1c1aced7c734 U3P01618RT |
| Fluorouracil | FLUOROURACIL | Fresenius Kabi USA, LLC | a85ab26a-05ea-498f-8f34-564a925fa9d9 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | ANDA040279 63323-117-41 63323-117-43 63323-117-28 63323-117-18 63323-117 1791736 1791701 239177 562eeb37-71b5-498d-9364-d70d06aaff4c a85ab26a-05ea-498f-8f34-564a925fa9d9 U3P01618RT |
| XIMONTH Fungi Free Bee Venom Nail Soothing Serum | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 53bab969-8407-6334-e063-6294a90aa5d1 | 2026-06-08 | Warnings | 059QF0KO0R |
| Fluorouracil | FLUOROURACIL | Fresenius Kabi USA, LLC | 21af1777-87f7-4e40-9917-f1677e7ff1a5 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | ANDA040278 63323-117-68 63323-117-58 63323-117 1791736 1791701 239177 774fb5db-0103-4bf9-94d1-ca910ef934f1 21af1777-87f7-4e40-9917-f1677e7ff1a5 U3P01618RT |
| FLUOROURACIL | FLUOROURACIL | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | b268684b-487f-4716-a2e8-6e6d3e117b14 | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | 239177 U3P01618RT |
| Bacteriostatic Water | BACTERIOSTATIC WATER | Hospira, Inc. | 87d6e9dc-fe3b-4593-ac9a-d7493d1959c7 | 2026-05-22 | Warnings, Adverse reactions | 059QF0KO0R |
| WHITENING SUNSCREENANTI WRINKLE | WHITENING SUNSCREENANTI WRINKLE | Shantou Oushiya Biotechnology Co.,Ltd | 524384e9-b3f8-4c13-e063-6394a90a8973 | 2026-05-20 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Hospira, Inc. | 3a6422e1-feee-4095-8883-2b0837039e6e | 2026-05-07 | Warnings, Adverse reactions | 059QF0KO0R |
| Multi Flower | AESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOS | Energique, Inc. | 09c059e7-f748-402c-8447-af5b61169c58 | 2026-05-06 | Warnings | 059QF0KO0R |
| Fluorouracil | FLUOROURACIL | Meitheal Pharmaceuticals Inc. | de8a3fce-85a9-4a77-a3cd-e50179b93098 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | 239177 U3P01618RT |
| Fluorouracil | FLUOROURACIL | Meitheal Pharmaceuticals Inc. | a0cd6301-c6e0-4b62-8683-39c99913db24 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | 239177 U3P01618RT |
| KIDS TOOTHPASTE, FOR CAVITY PROTECTION | KIDS TOOTHPASTE FOR CAVITY PROTECTION | Shulisa (Foshan) Daily ChemicalIndustry Co., Ltd | 4e8fab9e-f05c-5e2f-e063-6294a90aecf9 | 2026-04-03 | Warnings | 059QF0KO0R |
| Fluorouracil | FLUOROURACIL | Fresenius Kabi USA, LLC | c45f5286-a52b-43e5-8a6f-d0312e7da0c8 | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | ANDA040279 63323-117-20 63323-117-01 63323-117-00 63323-117-10 63323-117 63323011701 1791736 1791701 239177 0c579d19-82e7-4aac-bcb6-b3a60a3b48a3 c45f5286-a52b-43e5-8a6f-d0312e7da0c8 U3P01618RT |
| Sterile Water | WATER | Hospira, Inc. | 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828 | 2026-03-18 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.