NDC 52544-920-54 - OXYTROL

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: 52544-920
Requested NDC: 52544-920-54
Package NDCs from labels: 52544-920-54, 52544-920-08
Manufacturer: Actavis Pharma, Inc.
Effective date: 2015-07-24
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
OXYTROL - Actavis Pharma, Inc.	Actavis Pharma, Inc.	2015-07-24	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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52544-920-08	EA - Each	52544-920	e4188f57-f61e-4bcc-866e-ba52a5b19350	1	2012-07-24
52544-920-54	EA - Each	52544-920	8ec4ce37-c1c6-4ed5-ac70-0c180f421236	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYBUTYNIN	ACTIVE INGREDIENT	K9P6MC7092	OXYTROL (OXYBUTYNIN) PATCH [ACTAVIS PHARMA, INC.]	18
OXYBUTYNIN	ACTIVE MOIETY	K9P6MC7092	OXYTROL (OXYBUTYNIN) PATCH [ACTAVIS PHARMA, INC.]	18
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	OXYTROL (OXYBUTYNIN) PATCH [ACTAVIS PHARMA, INC.]	18

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxytrol for Women	OXYBUTYNIN	Allergan, Inc.	8cdc5b4d-ff8d-4010-97d7-313422a0b868	2024-08-15	Warnings	Exact identifier unii: K9P6MC7092
OXYTROL	OXYBUTYNIN	Allergan, Inc.	20dee37f-1412-44ed-9e8b-f4379ce23eb0	2024-05-29	Warnings, Adverse reactions	Exact identifier application number: NDA021351 unii: K9P6MC7092
f59c07ba-71fe-4a49-aa7e-f34b077df010			a162fd5b-b2ab-4d45-8861-71b60b92acb4	2015-07-24	Warnings, Adverse reactions	Exact identifier spl id: f59c07ba-71fe-4a49-aa7e-f34b077df010 spl set id: a162fd5b-b2ab-4d45-8861-71b60b92acb4

Reported adverse events (FAERS/openFDA)#

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