NDC 10139-061-01 - Epirubicin Hydrochloride

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: 10139-061
Requested NDC: 10139-061-01
Package NDCs from labels: 10139-061-01, 10139-061-25
Manufacturer: GeneraMedix, Inc.
Effective date: 2007-11-28
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
EPIRUBICIN HYDROCHLORIDE INJECTION Rx only	GeneraMedix, Inc.	2007-11-28	HUMAN PRESCRIPTION DRUG LABELING
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2013-02-13	Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10139-061-01	Epirubicin Hydrochloride	100 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	100		1
10139-061-25	Epirubicin Hydrochloride	25 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	25		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10139-061	EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN HYDROCHLORIDE) INJECTION, SOLUTION [GENERAMEDIX, INC.]	1	2 package rows	20071212_AACEE94D-15AF-4CCC-9CC9-6CD52905EC4E.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10139-061-01	ML - Milliliter	10139-061	98858758-e90a-4647-b3b2-a470b7f6db92	1	2013-02-13
10139-061-25	ML - Milliliter	10139-061	b5eb4a5e-b84e-4868-9a1c-ceea6b43b689	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
epirubicin hydrochloride	ACTIVE INGREDIENT	22966TX7J5	EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN HYDROCHLORIDE) INJECTION, SOLUTION [GENERAMEDIX, INC.]	1
epirubicin	ACTIVE MOIETY	3Z8479ZZ5X	EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN HYDROCHLORIDE) INJECTION, SOLUTION [GENERAMEDIX, INC.]	1
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN HYDROCHLORIDE) INJECTION, SOLUTION [GENERAMEDIX, INC.]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN HYDROCHLORIDE) INJECTION, SOLUTION [GENERAMEDIX, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN HYDROCHLORIDE) INJECTION, SOLUTION [GENERAMEDIX, 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
8B3C6343-80B9-2B4D-35CF-53288B851001			AACEE94D-15AF-4CCC-9CC9-6CD52905EC4E	2007-11-28	Boxed warning, Warnings, Adverse reactions	Exact identifier spl id: 8B3C6343-80B9-2B4D-35CF-53288B851001 spl set id: AACEE94D-15AF-4CCC-9CC9-6CD52905EC4E

Reported adverse events (FAERS/openFDA)#

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