Isosorbide Mononitrate

Product NDC
23155-628
11-digit product format
231550628
Labeler code
23155
Product ID
23155-628_649023db-b51a-4696-ae92-28c926efc2d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA210822
Marketing category
ANDA
Marketing start
2018-11-15
Marketing end
0000-00-00
Substance
ISOSORBIDE MONONITRATE
Active strength
120 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cc3f7505-fd5d-aab9-1128-173349f98a63Product name420230113
f23201a1-1f10-4748-0041-3c03fbb37cfbProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-628-01EA - Each23155-628fa194e81-3834-41c2-9bbe-d9451e2918f112019-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-628ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]8Legacy NDC20211203_ef08d90f-ba26-4b68-8e3a-d0320e4b0f8e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
23155-628-0123155062801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-628-01) 2018-11-150000-00-00NoNoCurrent