FDA.reportPublic FDA data

NDC 0054-8130-25 - 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
0054-8130
Requested NDC
0054-8130-25
Package NDCs from labels
0054-8130-25
Manufacturer
Roxane Laboratories, Inc.
Effective date
2006-11-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CYCLOPHOSPHAMIDE TABLETS USP, 25 mg and 50 mgRoxane Laboratories, Inc.2006-11-06Human prescription drug label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cyclophosphamideACTIVE INGREDIENT8N3DW7272PCYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) TABLET [ROXANE LABORATORIES, INC.]1
cyclophosphamideACTIVE MOIETY8N3DW7272PCYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) TABLET [ROXANE LABORATORIES, INC.]1
acaciaINACTIVE INGREDIENTCYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) TABLET [ROXANE LABORATORIES, INC.]1
FD&C Blue No. 1INACTIVE INGREDIENTCYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) TABLET [ROXANE LABORATORIES, INC.]1
lactose monohydrateINACTIVE INGREDIENTCYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) TABLET [ROXANE LABORATORIES, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) TABLET [ROXANE LABORATORIES, INC.]1
microcrystalline celluloseINACTIVE INGREDIENTCYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) TABLET [ROXANE LABORATORIES, INC.]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 1 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CyclophosphamideCYCLOPHOSPHAMIDENexus Pharmaceuticals, LLCc961a1ac-6705-4756-9abc-9d84a6fcb5c82026-09-03Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CyclophosphamideCYCLOPHOSPHAMIDEOPKO Pharmaceuticals, LLCd8057d1a-e8af-42ab-9da2-b545730b26552026-05-04Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CyclophosphamideCYCLOPHOSPHAMIDEOPKO Pharmaceuticals, LLC7d6447e3-22c9-48d9-87c0-d0b576d7ea9e2026-04-21Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CyclophosphamideCYCLOPHOSPHAMIDEBluePoint Laboratories1d3396d8-4c03-4a28-890a-d87c6c53a74e2026-03-12Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CyclophosphamideCYCLOPHOSPHAMIDEBluePoint Laboratoriesd7e97b99-83db-42d0-8521-b87fe6467a672026-02-12Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CyclophosphamideCYCLOPHOSPHAMIDEAvenacy, LLC1de02105-9c5b-4d11-bddf-bf8450d88b782026-02-01Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CyclophosphamideCYCLOPHOSPHAMIDEAmneal Pharmaceuticals LLC520bfe39-dfd5-4a20-9a37-80078afded0d2026-01-19Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBamboo US Bidco LCC2873b99a-830d-0a7b-e063-6394a90a4de72025-12-03Warnings, Adverse reactionsName fallback
brand name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEEpic Pharma, LLC988d2f71-1dc7-45b5-b2df-187e682249732025-11-17Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CyclophosphamideCYCLOPHOSPHAMIDECivica, Inc.8627c83f-c057-495d-9f78-8b67bda97b3e2025-10-24Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBluePoint Laboratories0afd2cc7-09e6-481a-afea-9d2e3742da462025-08-07Warnings, Adverse reactionsName fallback
brand name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEBaxter Healthcare Company591d9955-3d9c-4cdc-a308-2f1288376b9f2025-06-24Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEBaxter Healthcare Company97ab446f-5017-4180-ae65-0a355289b0ed2025-06-20Warnings, Adverse reactionsName fallback
brand name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDEEugia US LLC3c1eb470-0bba-457d-94e3-b9508f0d398a2025-04-21Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CyclophosphamideCYCLOPHOSPHAMIDE FOR INJECTIONSlate Run Pharmaceuticals, LLC20bda486-cb9a-4d67-8c41-50e9fd0664342025-04-02Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDEDr. Reddy's Labratories Inc.a5818647-d840-e9d7-c7b8-6541b485e44e2025-03-11Warnings, Adverse reactionsName fallback
brand name: CYCLOPHOSPHAMIDE
CyclophosphamideCYCLOPHOSPHAMIDESandoz Inc.0e9e22fa-178a-42fc-9f82-c303db3b245a2025-03-05Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CyclophosphamideCYCLOPHOSPHAMIDESagent Pharmaceuticals329b5a3a-c7b9-4b11-abf0-009719cdfb792025-01-22Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CyclophosphamideCYCLOPHOSPHAMIDECipla USA Inc.0e1cb955-99c8-4fe5-89d1-399c8e52174e2025-01-10Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide
CyclophosphamideCYCLOPHOSPHAMIDE FOR INJECTIONHainan Poly Pharm. Co., Ltd.6fde2705-a2d8-4d48-9618-b9d99d0513732025-01-03Warnings, Adverse reactionsName fallback
brand name: Cyclophosphamide

Reported adverse events (FAERS/openFDA)#

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