FDA.reportPublic FDA data

isosorbide mononitrate

Product NDC
67544-224
11-digit product format
675440224
Labeler code
67544
Product ID
67544-224_12d1eedc-151a-4775-8e83-9f64e967cb70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075155
Marketing category
ANDA
Marketing start
1998-10-30
Marketing end
0000-00-00
Substance
ISOSORBIDE MONONITRATE
Active strength
60 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67544-224-302023-01-30C16284748780-1f386c649-9e15-0266-e053-dadaa90a7c1aIsosorbide Mononitrate Extended-Release Tablets Rx only
67544-224-452023-01-30C16284748780-1f386c649-9e15-0266-e053-dadaa90a7c1aIsosorbide Mononitrate Extended-Release Tablets Rx only
67544-224-562023-01-30C16284748780-1f386c649-9e15-0266-e053-dadaa90a7c1aIsosorbide Mononitrate Extended-Release Tablets Rx only
67544-224-602023-01-30C16284748780-1f386c649-9e15-0266-e053-dadaa90a7c1aIsosorbide Mononitrate Extended-Release Tablets Rx only
67544-224-802023-01-30C16284748780-1f386c649-9e15-0266-e053-dadaa90a7c1aIsosorbide Mononitrate Extended-Release Tablets Rx only
67544-224-812023-01-30C16284748780-1f386c649-9e15-0266-e053-dadaa90a7c1aIsosorbide Mononitrate Extended-Release Tablets Rx only
67544-224-822023-01-30C16284748780-1f386c649-9e15-0266-e053-dadaa90a7c1aIsosorbide Mononitrate Extended-Release Tablets Rx only
67544-224-992023-01-30C16284748780-1f386c649-9e15-0266-e053-dadaa90a7c1aIsosorbide Mononitrate Extended-Release Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-224-30isosorbide mononitrate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE303
67544-224-45isosorbide mononitrate45 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE453
67544-224-56isosorbide mononitrate3000 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE30003
67544-224-60isosorbide mononitrate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE903
67544-224-80isosorbide mononitrate180 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1803
67544-224-81isosorbide mononitrate800 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE8003
67544-224-82isosorbide mononitrate1200 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE12003
67544-224-99isosorbide mononitrate600 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE6003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-224-30EA - Each67544-2249a66b9ce-9914-4bcb-9387-80318bde9b6212014-05-02
67544-224-45EA - Each67544-22404a64ad6-8d71-48f4-a8ea-5695e78d794412014-05-02
67544-224-56EA - Each67544-22444c3cf7a-105a-4110-bbef-e7ed1e92f46412014-06-03
67544-224-60EA - Each67544-224f558c5a2-f5dd-4b29-813d-2c0361ea62c012014-05-02
67544-224-80EA - Each67544-224c24899c3-5862-4c86-a52b-e5e5b53d9a9512014-05-02
67544-224-81EA - Each67544-2246f1d5a5f-a4ea-4b17-9059-a30dcd6271aa12014-09-03
67544-224-82EA - Each67544-224ec661ed4-24be-412e-9a89-38800ef7236612014-09-03
67544-224-99EA - Each67544-224557095bb-a848-4215-9238-7eeaf4fbada812014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ISOSORBIDE MONONITRATEACTIVE MOIETYLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-224ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 8 package rows20191224_a707727c-819f-43ea-89f3-2a2ae1cb9edf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSNa707727c-819f-43ea-89f3-2a2ae1cb9edf3
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCDa707727c-819f-43ea-89f3-2a2ae1cb9edf3
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSYa707727c-819f-43ea-89f3-2a2ae1cb9edf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67544-224-306754402243030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-224-30) 2007-03-310000-00-00NoNoCurrent
67544-224-456754402244545 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-224-45) 2007-02-070000-00-00NoNoCurrent
67544-224-56675440224563000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-224-56) 2013-06-280000-00-00NoNoCurrent
67544-224-606754402246090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-224-60) 2010-06-250000-00-00NoNoCurrent
67544-224-8067544022480180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-224-80) 2011-09-100000-00-00NoNoCurrent
67544-224-8167544022481800 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-224-81) 2006-09-060000-00-00NoNoCurrent
67544-224-82675440224821200 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-224-82) 2005-12-060000-00-00NoNoCurrent
67544-224-9967544022499600 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-224-99) 2006-09-060000-00-00NoNoCurrent