NDC 54396-110 - Oxandrin

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: 54396-110
Package NDCs from labels: 54396-110-60
Manufacturer: Savient Pharmaceuticals, Inc.
Effective date: 2007-04-09
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Oxandrin®(oxandrolone tablets, USP)CIII	Savient Pharmaceuticals, Inc.	2007-04-09	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54396-110-60	Oxandrin	60 in 1 BOTTLE	TABLET	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54396-110	OXANDRIN (OXANDROLONE) TABLET [SAVIENT PHARMACEUTICALS, INC.]	1	1 package rows	20070517_f622616e-4c11-4149-bf00-5ea5ce97800b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54396-110-60	EA - Each	54396-110	21c8d7f3-5d02-4f66-a2eb-d51c73b7c885	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
oxandrolone	ACTIVE INGREDIENT	7H6TM3CT4L	OXANDRIN (OXANDROLONE) TABLET [SAVIENT PHARMACEUTICALS, INC.]	1
oxandrolone	ACTIVE MOIETY	7H6TM3CT4L	OXANDRIN (OXANDROLONE) TABLET [SAVIENT PHARMACEUTICALS, INC.]	1
cornstarch	INACTIVE INGREDIENT		OXANDRIN (OXANDROLONE) TABLET [SAVIENT PHARMACEUTICALS, INC.]	1
hydroxypropyl methylcellulose	INACTIVE INGREDIENT		OXANDRIN (OXANDROLONE) TABLET [SAVIENT PHARMACEUTICALS, INC.]	1
lactose	INACTIVE INGREDIENT		OXANDRIN (OXANDROLONE) TABLET [SAVIENT PHARMACEUTICALS, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	OXANDRIN (OXANDROLONE) TABLET [SAVIENT PHARMACEUTICALS, 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
9DAB9B37-DF9A-8541-FDDC-4F82F5F0E3EB			f622616e-4c11-4149-bf00-5ea5ce97800b	2007-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier spl id: 9DAB9B37-DF9A-8541-FDDC-4F82F5F0E3EB spl set id: f622616e-4c11-4149-bf00-5ea5ce97800b

Reported adverse events (FAERS/openFDA)#

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