NDC 64116-021-01 - AMPHOTEC

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: 64116-021
Requested NDC: 64116-021-01
Package NDCs from labels: 64116-021-01
Manufacturer: InterMune, Inc.
Effective date: 2006-02-27
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
AMPHOTEC® Amphotericin B Cholesteryl Sulfate Complex for Injection	InterMune, Inc.	2006-02-27	Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64116-021-01	AMPHOTEC	20 mL in 1 VIAL, SINGLE-USE	INJECTION, LIPID COMPLEX	20		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64116-021	AMPHOTEC (AMPHOTERICIN B) INJECTION, LIPID COMPLEX [INTERMUNE, INC.]	1	1 package rows	20080313_9b8ea543-1de8-472f-9666-34f99ca2f183.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
amphotericin B	ACTIVE INGREDIENT	7XU7A7DROE	AMPHOTEC (AMPHOTERICIN B) INJECTION, LIPID COMPLEX [INTERMUNE, INC.]	1
amphotericin B	ACTIVE MOIETY	7XU7A7DROE	AMPHOTEC (AMPHOTERICIN B) INJECTION, LIPID COMPLEX [INTERMUNE, INC.]	1
disodium edetate dihydrate	INACTIVE INGREDIENT		AMPHOTEC (AMPHOTERICIN B) INJECTION, LIPID COMPLEX [INTERMUNE, INC.]	1
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	AMPHOTEC (AMPHOTERICIN B) INJECTION, LIPID COMPLEX [INTERMUNE, INC.]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	AMPHOTEC (AMPHOTERICIN B) INJECTION, LIPID COMPLEX [INTERMUNE, INC.]	1
sodium cholesteryl sulfate	INACTIVE INGREDIENT		AMPHOTEC (AMPHOTERICIN B) INJECTION, LIPID COMPLEX [INTERMUNE, INC.]	1
tromethamine	INACTIVE INGREDIENT	023C2WHX2V	AMPHOTEC (AMPHOTERICIN B) INJECTION, LIPID COMPLEX [INTERMUNE, 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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
4A32D598-0CAF-DBE7-12E3-4CD865EC9DF9			9b8ea543-1de8-472f-9666-34f99ca2f183	2006-02-27	Warnings, Adverse reactions	Exact identifier spl id: 4A32D598-0CAF-DBE7-12E3-4CD865EC9DF9 spl set id: 9b8ea543-1de8-472f-9666-34f99ca2f183

Reported adverse events (FAERS/openFDA)#

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