FDA.reportPublic FDA data

NDC 14335-470-01 - Cyclophosphamide

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
14335-470
Requested NDC
14335-470-01
Package NDCs from labels
14335-470-01, 14335-470-10
Manufacturer
Hainan Poly Pharm. Co., Ltd.
Effective date
2025-01-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyclophosphamide for Injection - Hainan Poly Pharm. Co., Ltd.Hainan Poly Pharm. Co., Ltd.2025-01-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14335-470-01Cyclophosphamide25 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION251
14335-470-10Cyclophosphamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14335-470CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE FOR INJECTION) INJECTION, POWDER, FOR SOLUTION [HAINAN POLY PHARM. CO., LTD.]1Current NDC, 2 package rows20250104_6fde2705-a2d8-4d48-9618-b9d99d051373.zip

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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CyclophosphamideCYCLOPHOSPHAMIDENexus Pharmaceuticals, LLCc961a1ac-6705-4756-9abc-9d84a6fcb5c82026-09-03Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
FrindovyxCYCLOPHOSPHAMIDEAVYXA Pharma, LLC5ad8ea65-4c98-487a-9c8d-df778765ec5e2026-08-26Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEOPKO Pharmaceuticals, LLCd8057d1a-e8af-42ab-9da2-b545730b26552026-05-04Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEOPKO Pharmaceuticals, LLC7d6447e3-22c9-48d9-87c0-d0b576d7ea9e2026-04-21Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEBluePoint Laboratories1d3396d8-4c03-4a28-890a-d87c6c53a74e2026-03-12Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEBluePoint Laboratoriesd7e97b99-83db-42d0-8521-b87fe6467a672026-02-12Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEAvenacy, LLC1de02105-9c5b-4d11-bddf-bf8450d88b782026-02-01Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEAmneal Pharmaceuticals LLC520bfe39-dfd5-4a20-9a37-80078afded0d2026-01-19Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBamboo US Bidco LCC2873b99a-830d-0a7b-e063-6394a90a4de72025-12-03Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEEpic Pharma, LLC988d2f71-1dc7-45b5-b2df-187e682249732025-11-17Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDECivica, Inc.8627c83f-c057-495d-9f78-8b67bda97b3e2025-10-24Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEBaxter Healthcare Company591d9955-3d9c-4cdc-a308-2f1288376b9f2025-06-24Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Company97ab446f-5017-4180-ae65-0a355289b0ed2025-06-20Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDEEugia US LLC3c1eb470-0bba-457d-94e3-b9508f0d398a2025-04-21Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDE FOR INJECTIONSlate Run Pharmaceuticals, LLC20bda486-cb9a-4d67-8c41-50e9fd0664342025-04-02Warnings, Adverse reactionsExact identifier
application number: ANDA218632
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDESandoz Inc.0e9e22fa-178a-42fc-9f82-c303db3b245a2025-03-05Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDESagent Pharmaceuticals329b5a3a-c7b9-4b11-abf0-009719cdfb792025-01-22Warnings, Adverse reactionsExact identifier
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDECipla USA Inc.0e1cb955-99c8-4fe5-89d1-399c8e52174e2025-01-10Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDE FOR INJECTIONHainan Poly Pharm. Co., Ltd.6fde2705-a2d8-4d48-9618-b9d99d0513732025-01-03Warnings, Adverse reactionsExact identifier
application number: ANDA218632
ndc (package): 14335-471-10
ndc (package): 14335-472-10
ndc (package): 14335-470-01
ndc (package): 14335-472-01
ndc (package): 14335-471-01
ndc (package): 14335-470-10
ndc (product): 14335-471
ndc (product): 14335-472
ndc (product): 14335-470
ndc11 (package): 14335047001
rxcui: 1734921
rxcui: 1734917
rxcui: 1734919
spl id: 2aca7731-9fcc-4625-e063-6394a90a6020
spl set id: 6fde2705-a2d8-4d48-9618-b9d99d051373
unii: 8N3DW7272P
CyclophosphamideCYCLOPHOSPHAMIDESandoz Inccf2f4b95-0327-499a-a5a3-51b1bdef68c52024-12-30Warnings, Adverse reactionsExact identifier
unii: 8N3DW7272P

Reported adverse events (FAERS/openFDA)#

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