NDC 66657-301-01 - GANITE

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: 66657-301
Requested NDC: 66657-301-01
Package NDCs from labels: 66657-301-01, 66657-301-05
Manufacturer: Genta Incorporated | Cangene BioPharma Inc
Effective date: 2012-03-19
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
GANITE - Genta Incorporated \| Cangene BioPharma Inc	Genta Incorporated \| Cangene BioPharma Inc	2012-03-19	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66657-301-05	2019-11-13	C162847	48780-1	97449f38-c125-f6ea-e053-dbdaa90aa703	Ganite® (gallium nitrate injection)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66657-301-01	GANITE	20 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION, CONCENTRATE	20		4
66657-301-05	GANITE	5 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66657-301	GANITE (GALLIUM NITRATE) INJECTION, SOLUTION, CONCENTRATE [GENTA INCORPORATED]	4	2 package rows	20120323_8bc2ddf8-d695-46b3-bf76-9f85ce6027e3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66657-301-01	ML - Milliliter	66657-301	c178db83-059e-48b3-b6a5-a425d6ce645a	1	2012-07-24
66657-301-05	ML - Milliliter	66657-301	18a5a3ff-58df-4bf1-aa0b-528d13799194	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GALLIUM NITRATE	ACTIVE INGREDIENT	VRA0C6810N	GANITE (GALLIUM NITRATE) INJECTION, SOLUTION, CONCENTRATE [GENTA INCORPORATED]	4
Gallium cation	ACTIVE MOIETY	F7K5MP217W	GANITE (GALLIUM NITRATE) INJECTION, SOLUTION, CONCENTRATE [GENTA INCORPORATED]	4
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	GANITE (GALLIUM NITRATE) INJECTION, SOLUTION, CONCENTRATE [GENTA INCORPORATED]	4

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 3 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	448a1dc5-7a98-4b2f-82af-4b92de05cfc3	2019-11-18		Exact identifier unii: B22547B95K
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	051f7347-5a76-4664-8fe2-e61b3dfcb0e4	2014-08-27		Exact identifier unii: B22547B95K
91011848-9bcb-4ccc-83b1-a53c4d8e219b			8bc2ddf8-d695-46b3-bf76-9f85ce6027e3	2012-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier spl id: 91011848-9bcb-4ccc-83b1-a53c4d8e219b spl set id: 8bc2ddf8-d695-46b3-bf76-9f85ce6027e3

Reported adverse events (FAERS/openFDA)#

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