PREXXARTAN

Product NDC: 25208-100
11-digit product format: 252080100
Labeler code: 25208
Product ID: 25208-100_7ad4ad18-919e-48fe-b630-213ead75a8b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREXXARTAN
Dosage form: SOLUTION
Route: ORAL
Labeler: Medicure International Inc.
Application: NDA209139
Marketing category: NDA
Marketing start: 2018-01-02
Marketing end: 0000-00-00
Substance: VALSARTAN
Active strength: 4 mg/mL
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
25208-100-06	2020-01-31	C162847	48780-1	9d75b9d0-9553-f424-e053-dadaa90a57ce	df73d781-65d8-4aaa-9b0f-de4341f639ec
25208-100-07	2020-01-31	C162847	48780-1	9d75b9d0-9553-f424-e053-dadaa90a57ce	df73d781-65d8-4aaa-9b0f-de4341f639ec
25208-100-08	2020-01-31	C162847	48780-1	9d75b9d0-9553-f424-e053-dadaa90a57ce	df73d781-65d8-4aaa-9b0f-de4341f639ec

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25208-100	PREXXARTAN SOLUTION [MEDICURE INTERNATIONAL INC.]	1	Legacy NDC	20180115_df73d781-65d8-4aaa-9b0f-de4341f639ec.zip