NDC 0054-8089-25 - 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: 0054-8089
Requested NDC: 0054-8089-25
Package NDCs from labels: 0054-8089-25
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
Label	Manufacturer	Effective date	Type
CYCLOPHOSPHAMIDE TABLETS USP, 25 mg and 50 mg	Roxane Laboratories, Inc.	2006-11-06	Human prescription drug label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
cyclophosphamide	ACTIVE INGREDIENT	8N3DW7272P	CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) TABLET [ROXANE LABORATORIES, INC.]	1
cyclophosphamide	ACTIVE MOIETY	8N3DW7272P	CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) TABLET [ROXANE LABORATORIES, INC.]	1
acacia	INACTIVE INGREDIENT		CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) TABLET [ROXANE LABORATORIES, INC.]	1
FD&C Blue No. 1	INACTIVE INGREDIENT		CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) TABLET [ROXANE LABORATORIES, INC.]	1
lactose monohydrate	INACTIVE INGREDIENT		CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) TABLET [ROXANE LABORATORIES, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) TABLET [ROXANE LABORATORIES, INC.]	1
microcrystalline cellulose	INACTIVE INGREDIENT		CYCLOPHOSPHAMIDE (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 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyclophosphamide	CYCLOPHOSPHAMIDE	Alembic Pharmaceuticals Limited	9e699cf7-860e-4c03-9760-0c24d56df2de	2024-12-16	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide
Cyclophosphamide	CYCLOPHOSPHAMIDE	Alembic Pharmaceuticals Inc.	3d6e68b1-5120-4cbb-a9d2-fb09d1b74ea1	2024-12-10	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide
Cyclophosphamide	CYCLOPHOSPHAMIDE	NorthStar Rx LLC	76f057be-e3da-0a89-e053-2a91aa0a8438	2024-11-20	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide
Cyclophosphamide	CYCLOPHOSPHAMIDE	Hikma Pharmaceuticals USA Inc.	8135b917-882f-4b4c-99b7-fa8ea54af4bf	2024-11-19	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide
Cyclophosphamide	CYCLOPHOSPHAMIDE	Fresenius Kabi USA, LLC	31986d36-a1bf-4903-93a4-ce7386241ba1	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide
Cyclophosphamide	CYCLOPHOSPHAMIDE	Avyxa Pharma, LLC	6f593585-e0dd-48bc-bd2b-c6c787e0b98c	2024-07-26	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide
Cyclophosphamide	CYCLOPHOSPHAMIDE INJECTION, SOLUTION	Baxter Healthcare Company	34dbffee-80e0-49c3-90e8-95713a0b7fbe	2024-04-10	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide
Cyclophosphamide	CYCLOPHOSPHAMIDE	Baxter Healthcare Corporation	769ded74-6186-40a8-8e44-ceff67287451	2020-08-07	Warnings, Adverse reactions	Name fallback brand name: Cyclophosphamide
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	Baxter Healthcare Company	cef038cc-efab-46d9-99c2-95bb11d6c9bc	2017-03-15	Warnings, Adverse reactions	Name fallback brand name: CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	Baxter Healthcare Company	6bae5c14-9e87-4fb6-ae9c-4d875c1ecffe	2017-03-15	Warnings, Adverse reactions	Name fallback brand name: CYCLOPHOSPHAMIDE

Reported adverse events (FAERS/openFDA)#

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