NDC 45414-311 - Fludarabine Phosphate

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: 45414-311
Package NDCs from labels: 45414-311-15, 45414-311-20
Manufacturer: Antisoma Research Limited
Effective date: 2009-02-18
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Fludarabine Phosphate - Antisoma Research Limited	Antisoma Research Limited	2009-02-18	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
45414-311-15	Fludarabine Phosphate	3 in 1 BOTTLE	TABLET, FILM COATED	3	1
45414-311-15	Fludarabine Phosphate	1 in 1 CARTON	TABLET, FILM COATED	1	1
45414-311-20	Fludarabine Phosphate	4 in 1 BOTTLE	TABLET, FILM COATED	4	1
45414-311-20	Fludarabine Phosphate	1 in 1 CARTON	TABLET, FILM COATED	1	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45414-311	FLUDARABINE PHOSPHATE TABLET, FILM COATED [ANTISOMA RESEARCH LIMITED]	1	4 package rows	20090310_AC76ACA8-E718-4232-92AB-399166CE9E46.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUDARABINE PHOSPHATE	ACTIVE INGREDIENT	1X9VK9O1SC	FLUDARABINE PHOSPHATE TABLET, FILM COATED [ANTISOMA RESEARCH LIMITED]	1
FLUDARABINE	ACTIVE MOIETY	P2K93U8740	FLUDARABINE PHOSPHATE TABLET, FILM COATED [ANTISOMA RESEARCH LIMITED]	1
colloidal anhydrous silicon dioxide	INACTIVE INGREDIENT		FLUDARABINE PHOSPHATE TABLET, FILM COATED [ANTISOMA RESEARCH LIMITED]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	FLUDARABINE PHOSPHATE TABLET, FILM COATED [ANTISOMA RESEARCH LIMITED]	1
ferric oxide pigment (red/E172, yellow/E172)	INACTIVE INGREDIENT		FLUDARABINE PHOSPHATE TABLET, FILM COATED [ANTISOMA RESEARCH LIMITED]	1
hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	FLUDARABINE PHOSPHATE TABLET, FILM COATED [ANTISOMA RESEARCH LIMITED]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	FLUDARABINE PHOSPHATE TABLET, FILM COATED [ANTISOMA RESEARCH LIMITED]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	FLUDARABINE PHOSPHATE TABLET, FILM COATED [ANTISOMA RESEARCH LIMITED]	1
microcrystalline cellulose	INACTIVE INGREDIENT	OP1R32D61U	FLUDARABINE PHOSPHATE TABLET, FILM COATED [ANTISOMA RESEARCH LIMITED]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	FLUDARABINE PHOSPHATE TABLET, FILM COATED [ANTISOMA RESEARCH LIMITED]	1
titanium dioxide (E171)	INACTIVE INGREDIENT		FLUDARABINE PHOSPHATE TABLET, FILM COATED [ANTISOMA RESEARCH LIMITED]	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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fludarabine	FLUDARABINE PHOSPHATE	Fresenius Kabi USA, LLC	cf5255cc-91fd-4132-973b-764dba142eae	2024-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fludarabine
Fludarabine Phosphate	FLUDARABINE PHOSPHATE	Areva Pharmaceuticals	8039c2e3-ffe5-3997-e053-2991aa0ad9d0	2023-02-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fludarabine Phosphate
Fludarabine Phosphate	FLUDARABINE PHOSPHATE	Lannett Company, Inc.	0170c0f4-d502-4f8f-bdbf-6439f3ed33fb	2023-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fludarabine Phosphate
Fludarabine phosphate	FLUDARABINE PHOSPHATE	Actavis Pharma, Inc.	3adca34b-4f65-4e21-8058-3c01fc7fc9bb	2022-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fludarabine phosphate
Fludarabine Phosphate	FLUDARABINE PHOSPHATE	Sagent Pharmaceuticals	20e5acf0-90b7-45c8-be78-91eaf77c9ac0	2021-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fludarabine Phosphate

Reported adverse events (FAERS/openFDA)#

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