isosorbide mononitrate

Product NDC
62175-107
11-digit product format
621750107
Labeler code
62175
Product ID
62175-107_81e3e7e0-b677-4948-9e04-6c3a44ea313b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide mononitrate
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
Application
NDA020215
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1993-06-30
Substance
ISOSORBIDE MONONITRATE
Active strength
20 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
isosorbide mononitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOSORBIDE MONONITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX1OH63030
Rxcui311192, 311197

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62175-107-01isosorbide mononitrate100 in 1 BOTTLETABLET1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62175-107ISOSORBIDE MONONITRATE TABLET [LANNETT COMPANY, INC.]8Current NDC, Legacy NDC, 1 package rows20220804_bf9e7e35-7707-42a0-88d6-6292fa52bbfa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311192isosorbide mononitrate 10 MG Oral TabletPSNbf9e7e35-7707-42a0-88d6-6292fa52bbfa8
311197isosorbide mononitrate 20 MG Oral TabletPSNbf9e7e35-7707-42a0-88d6-6292fa52bbfa8
311192isosorbide mononitrate 10 MG Oral TabletSCDbf9e7e35-7707-42a0-88d6-6292fa52bbfa8
311197isosorbide mononitrate 20 MG Oral TabletSCDbf9e7e35-7707-42a0-88d6-6292fa52bbfa8
311197isosorbide mononitrate 20 MG Oral TabletPSNcfd423bb-34ae-42a9-955e-1ea6aa31a8c64
311197isosorbide mononitrate 20 MG Oral TabletSCDcfd423bb-34ae-42a9-955e-1ea6aa31a8c64
311197isosorbide mononitrate 20 MG Oral TabletPSNf871dfa7-219f-4704-8e4d-215caeb7408d3
311197isosorbide mononitrate 20 MG Oral TabletSCDf871dfa7-219f-4704-8e4d-215caeb7408d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62175-107-0162175010701100 TABLET in 1 BOTTLE (62175-107-01) 100 tablet1993-06-300000-00-00NoNoCurrent